SPINE Volume 30, Number 7, pp 711721 2005, Lippincott Williams & Wilkins, Inc.

A Randomized Clinical Trial Comparing Two Physiotherapy Interventions for Chronic Low Back Pain
Jeremy S. Lewis, PhD, PT, Jane S. Hewitt, MSc, PT, Lisa Billington, BSc, PT, Sally Cole, MSc, PT, Jenny Byng, MSc, PT, and Sandra Karayiannis, BSc, PT
will present to their GP with LBP with 32% presenting for repeated consultations.1,2 It has been suggested that 70% of sufferers are better in 1 month3 and 80 to 90% of patients will recover in 6 weeks without any intervention.4 However, there appears to be a trend toward chronic low back pain (CLBP) with 40% of subjects reporting pain at 6 months5 and 33% still experiencing pain at 1 to 2 years.6 The nancial cost of LBP is substantial. In 1993 LBP cost the National Health Service 480 million with an associated 3.8 billion cost to industry.7 The etiology of CLBP is generally unknown and the diagnostic label, nonspecic LBP, is frequently given when no specic pathologic process or structure can be identied. As a result of the nonspecic nature of the condition, a myriad of conservative treatment techniques has been proposed, each technique aiming to address a largely hypothetical pathologic process. These techniques are generally very varied and apparently contradictory in philosophy. Examples of these diverse beliefs relating to treating pathologic processes include: joint mobilization to treat restricted spinal segments and specic segmental stabilization exercises to treat spinal segmental instability.8 11 The confusion for clinicians is increased when the evidence to assess specic pathologies, such as palpation to assess spinal stiffness, has clearly been shown to be unreliable,12 and the evidence to demonstrate the reliability of clinically assessing segmental spinal instability is also lacking. There is however, strong evidence for exercise therapy in the treatment of CLBP.10,1316 However, the choice of exercise therapy is also fraught with difculty for the clinician because aerobic exercises, strengthening exercises, coordination exercises, and specic stabilization exercises have been shown to be effective in the treatment of this condition.8,10,11,13,14,16,17 There is also a distinct lack of guidance as to whether it is more effective to administer exercises on an individual basis or in a group setting.10 14 The clinician is therefore in an uncertain position as to what form of exercise therapy to prescribe and in what manner to prescribe it. Spinal mobilization is another frequently used conservative technique.8,9,18 It involves the application of a low velocity, repetitive passive movement and has been hypothesized to decrease joint stiffness, reposition subluxed joints, free adhesions around the zygapophysial joints, and to be involved with the neuromodulation of pain.9,19 22 The exact effect of the procedure is unknown. There is additional confusion for clinicians, because seemingly very similar techniques to mobilization, such as acupressure massage and myo711

Study Design. A randomized clinical trial with blinded assessment. Objectives. To investigate the clinical efcacy of 2 active interventions for patients with chronic low back pain. Summary of Background Data. Manual therapy and exercise prescription are treatments frequently prescribed for patients with chronic low back pain. The evidence for the relative benet of these treatments is limited, and questions concerning the most appropriate type of intervention remain unanswered. Methods. Eighty patients with chronic low back pain (3 months) were randomized to one of the following treatments, involving 8 treatments over 8 weeks; 1) oneto-one treatment involving 30 minutes of manual therapy (mobilizations to the spine) and spinal stabilization exercises, and 2) a 10 station exercise class involving aerobic exercises, spinal stabilization exercises, and manual therapy. Three physiotherapists led the hour long group with a maximum of 10 patients. Questionnaires were completed, and physical measurements were taken by a blinded observer before randomization, at the completion of treatment, and at 6 months and 12 months after the completion of treatment. The intention-to-treat principle was used in data analysis. Results. Eleven patients dropped out of the individual treatment sessions and 7 dropped out of the exercise group. There was a signicant reduction (reduced disability) in the questionnaire score in both groups, and there were signicant increases in range for all the physical movements tested in both groups. The exercise group was 40% more cost effective than the individual treatments. Conclusion. Both forms of intervention were associated with signicant improvement. On-going clinical research is necessary to provide guidance as to the clinical efcacy of various forms of intervention. Key words: chronic low back pain, physiotherapy, manual therapy, exercises, rehabilitation, cost effectiveness. Spine 2005;30:711721

Low back pain (LBP) is associated with substantial morbidity for 80% of the general population at some stage during their lives. Annually, 7% of the adult population
From the Therapy Department, Chelsea & Westminster Healthcare National Health Service Trust, London, United Kingdom. Acknowledgment date: February 25, 2004: First revision date: April 14, 2004. Acceptance date: April 23, 2004. The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. No benets in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Address correspondence and reprint requests to Dr Jeremy Lewis, PhD, Therapy Department, Chelsea & Westminster Healthcare NHS Trust, 369 Fulham Road, London SW10 9NH, UK; E-mail: jeremy.lewis@chelwest.nhs.uk

712 Spine Volume 30 Number 7 2005

fascial trigger point massage, are applied in an analogous fashion, but the philosophy that underpins the application of each technique is extremely diverse. The purpose of this pragmatic study was to compare the outcome of two different, but commonly used, forms of physiotherapy intervention for patients with nonspecic CLBP. One involved individualized (one-to-one) treatment (mobilization and spinal stabilization exercises), and the other, a group exercise approach (offering a variety of exercises and techniques). These two forms of treatment are commonly used by physiotherapists, and the aim of this study was to add to the body of knowledge required to help guide clinicians into effective treatment choices for patients with CLBP. The null hypothesis for this investigation was that neither form of treatment would statistically be more benecial than the other. Materials and Methods Design. The study was a prospective, randomized clinical trial
with unblinded treatment and blinded outcome assessment. On the basis of recommendations to detect a minimum clinical important difference of 15 points in the main outcome measure (Quebec back pain disability scale)23,24 for a power of 0.8 and an alpha of 0.05, 28 subjects would be required in each group. Because of the transient nature of the population around the hospital where the investigation was conducted, it was expected that there would be up to 30% withdrawal/loss to follow-up with subjects in each group. This suggested that a total of 40 subjects would need to be recruited into each group at the start of the study. The nature of the interventions precluded any blinding of physiotherapists or participants to the assigned treatments. Potential participants received oral and written information pertaining to the study. Ethical approval was granted by the local ethics committee (Riverside Research Ethics Committee) at the teaching hospital where the study was conducted. Participating subjects signed informed consent documentation.

Participants. Patients with LBP referred by their consultant or family physician to physiotherapy were invited to participate in the study. Inclusion criteria were as follows: subjects between the ages of 18 to 75 years, uency in English, and mechanical low back pain for 3 months (of a nonradicular nature). Mechanical pain was dened as LBP, which increased with movement. Exclusion criteria were cardiac, respiratory, kidney, blood pressure or blood circulatory problems, spinal surgery, fracture, inammatory or infectious diseases of the spine, metabolic disease, neurological decit, rheumatoid arthritis or diabetes, health professionals, and staff members at the institution where data were collected. Potential subjects who were pregnant, or attempting to become pregnant, or who were not capable of participating in a graded exercise program were also excluded. Interventions. Using random number tables, subjects were
assigned to group 1 (exercise class) or group 2 (individual treatment). The exercise class consisted of 8, 1-hour sessions conducted over 2 months, and was conducted in an out-patient gym. Ten patients participated in the class, which was led by 3 (occasionally 2) physiotherapists. The class consisted of a number of stations that included treadmill, exercise bicycle, sit to

stand repetitions, spinal stabilization exercises (supine, prone, four-point kneeling), sitting gym ball exercises, leg press, bridging exercises, step ups (onto 12-cm step), stepper (Tanturi Tristepper 500, Helsinki, Finland), arm circling and arm raising (in standing), high-stepping on the spot (touching opposite hand to knee), walking to jogging on trampette, and gym ball (5 kg) lifts toward ceiling in supine position. There was also a curtained off manual therapy station that formed part of the circuit. Subjects would generally spend 2 minutes (approximately 5 minutes) at this station and would then reenter the circuit following individual treatment. The same physiotherapist treated the same patient during these manual therapy sessions. Instructions and diagrams were available at each station to remind the participants of the activity involved, and the physiotherapists moved between stations with explanations, encouragement, and guidance for the subjects. Not all subjects would receive mobilization each class, and most subjects received 6 sessions during the 8 session program. Individual targets (speed and repetitions) were set for each patient for the 2 minutes spent at each station. The 40-minute circuit was preceded by 10 minutes of warm up that consisted of walking and general stretching exercises and was followed by a 10 minute cool down also consisting of walking and stretching. Each subject had an individual program that indicated levels and exercise targets for each station and for the progression of the program. The individuals baseline was determined during the rst session. As one subject completed the 8 sessions, another would enter the program. Group 2 consisted of 8, 30minute sessions of individual treatment involving manual therapy and spinal stabilization exercises, where the same physiotherapists treated the same patient during the 8 sessions. Group 2 subjects were also instructed in spinal stabilization exercises and were progressed according to their individual ability. All manual therapy techniques were performed by physiotherapists who had completed recognized 1 year postgraduate MSc courses in manual therapy. The treating therapists were at liberty to choose the manual therapy technique they felt most suitable for the individual patient. These included Maitland mobilization techniques,9 Mulligan mobilization techniques,19 McKenzie techniques,25 and a variety of soft tissue techniques. Spinal stabilization exercises for both groups followed recommendations made by OSullivan et al26 All subjects received a copy of The Back Book (The Stationery Ofce, PO Box 29, Norwich, NR3 1GN, UK), which addresses commonly asked questions relating to aspects of LBP. Subjects were encouraged to discuss issues in greater depth with their treating physiotherapists.

Outcome Measurements. Two assessors blinded to group

allocation administered questionnaires and conducted physical assessments, before group allocation, immediately following treatment, and then at 6 months and 12 months following treatment. At the rst data collection stage the subjects height and weight were recorded, the duration of their symptoms, and whether the symptoms were constant or intermittent. Any previous conservative treatment was also recorded. At each data collection stage subjects completed the Quebec back pain disability scale.24 This is a 20-item self-administered instrument designed to assess the level of functional disability. Each item is scored on a scale from 0 to 5. The maximum score of 100 represents maximum disability. Subjects were also asked to rate their perceived level of physical tness on a 5-point scale where 1 represented very unt and 5 represented an excellent

Two Physiotherapy Interventions for Chronic LBP Lewis et al 713

Table 1. Intra- and Intertester Reliability Study

Tester 1 ICC (2,1) Flexion (cm) Extension (cm) Left SF (cm) Right SF (cm) Left SLR () Right SLR () 0.98 0.98 0.89 0.96 0.99 0.97 95% CI 0.880.99 0.910.99 0.320.98 0.770.99 0.950.99 0.820.99 Tester 2 ICC (2,1) 0.98 0.99 0.91 0.94 0.97 0.97 95% CI 0.900.99 0.920.99 0.190.98 0.340.99 0.860.99 0.870.99 Tester 1: Tester 2 First Data Collection ICC (2,1) 0.99 0.99 0.96 0.86 0.97 0.97 95% CI 0.940.99 0.930.99 0.800.99 0.270.98 0.720.99 0.850.99 Tester 1: Tester 2 Second Data Collection ICC (2,1) 0.99 0.96 0.93 0.94 0.98 0.95 95% CI 0.960.99 0.800.99 0.630.99 0.660.99 0.900.99 0.680.99 SEM 2.2cm 1.2cm 1.8cm 1.2cm 2.3 3.7

SF side exion; SLR straight leg raise.

level of tness. Subjects were asked to indicate if they were using analgesics for their LBP and if they were smokers and how many cigarettes they smoked on a daily basis. Aftertreatment and at the 6 and 12 month data collection stages, each subject was also asked to detail any additional treatment, if they felt that their condition had improved or not, to state the percentage of change (positive or negative), if they would do (or had done the prescribed exercises), and to rate their level of condence relating to their LBP. Condence was measured on a 3-point scale where 1 represented less condent, 2 represented no change, and 3 represented more condence about their back. At each data collection stage the following physical measurements were taken: Lumbar Flexion. In standing, subjects were asked to slide their hands down the front of their legs until they experienced the rst point of pain or the rst increase in pain. The distance from the end of the middle nger to the oor was measured using a standard nonstretch berglass tape measure. Subjects were then requested to mark the intensity of pain on a horizontal 10 cm visual analog scale (VAS) for pain, where the left side represented no pain and the right side represented the worst pain imaginable. Lumbar Extension. Measured in the same way with subjects sliding their hands down the posterior aspect of their legs. Side Flexion. Left and right side exion were measured in the same way with subjects sliding their hands down the lateral aspects of their left and right legs, respectively. Straight Leg Raise. In supine position the range of left and right SLR (straight leg raise) was measured by placing the proximal peg of an inclinometer (Isomed, Portland, OR) on the tibial tuberosity. The leg was passively elevated, and the angle at the rst point of pain, or rst increase in pain, was read off the inclinometer. The subjects then marked the intensity of pain on the VAS (pain) line.

come indicators in the main investigation were of acceptable clinical reliability.27 The values for the SEM suggested that measurements less than or equal to the values obtained should be considered as measurement error, and values above these gures should be considered as real change.

Statistical Analysis. The data were analyzed using the intention to treat principle. Data were analyzed using simple percentages and where appropriate paired t tests, independent t tests, 2 analysis, and Kendall correlation coefcient. Data analysis was performed using Statistical Package for the Social Sciences version 12.0 software (SPSS, Woking, Surrey, UK).

Results Figure 1 details subject entry into the study, randomization, and subject numbers including subjects lost to follow-up at each stage of the investigation. Table 2 details the demographic data for the two groups after randomization. Table 3 details the within group and between group interaction over the 12-month period for the questionnaire score and the ranges of movement for both groups of patients. Table 4 details the within group and between group interaction for the VAS (pain) associated with the movements for both groups of patients. After randomization, there was no statistical difference between the groups for the ranges of lumbar exion, extension, left side exion, and left and right SLR. There was also no difference for the VAS (pain) scores for exion, extension, and left and right side exion. However, there were signicant differences in the questionnaire scores, right side exion range, and left and right SLR VAS (pain) scores. The exercise group had statistically higher questionnaire scores (greater disability), less range of right side exion, and more pain during SLR than the individual treatment group. These differences at the baseline measurements represented a failure of the randomization process to produce 2 identically matched groups in all the parameters of interest. Questionnaire There was a statistically signicant reduction in questionnaire scores in both groups. The mean decrease in the exercise group was 15.1, and the corresponding result was 15.4 in the individual treatment group. Both groups

Preparatory Study. A pilot study was conducted on 6 asymptomatic subjects [2 males, 4 females, mean age 27.6 years (SD 4.7)] to determine the reliability of the investigators to measure the ranges of movement with the tape measure and inclinometer. The measurements that would be used in the main study were taken twice by the 2 investigators blinded to any previous data input. The single measure intraclass correlation coefcient [ICC (2,1)], 95% condence interval (CI) and SEM results are detailed in Table 1. The results for the intra- and intertester reliability study suggested that the measurements that would be used as out-

714 Spine Volume 30 Number 7 2005

Figure 1. Progression of participants through the trial including withdrawals and losses to follow-up. S subject; BP blood pressure; GI gastrointestinal; UTA unable to attend.

achieved the minimum clinically important difference to detect real change using this disability scale.23 Ranges of Movement and VAS (Pain) At 12 months aftertreatment, there was a mean increase in 8.5-cm exion range, 2-cm extension range, 2.5-cm left side exion range, 2.7-cm right side exion range, 12.6 left SLR range, and 10.5 right SLR range in the exercise group. These changes represented a statistically signicant improvement in all the outcome measureTable 2. Subject Demographics

ments of interest between the baseline and 12-month measurements. The corresponding results for the individual treatment group were 12.5 cm (exion), 1.5 cm (extension), 2.5 cm (left side exion), 1.3 cm (right side exion), 12.1 (left SLR), and 12.2 (right SLR). With the exception of left and right side exion, these results were statistically signicant. At 12 months, there were statistically signicant decreases in VAS (pain) for all movements, except left side exion, in the exercise

Group 1: Exercise Group (n 40) Gender Age (years) Height (cm) Weight (kg) Duration of symptoms (years) Pain behavior Analgesic use Smokers Past treatment Female 26 (65%) Male 14 (35%) 46.1 (SD 12.7) 168.4 (SD 9.5) 75.6 (SD 20.8) 11.1 (SD 12.6) 27 (67.5%) constant pain aggravated by movement 13 (32.5%) pain aggravated by movement 25 (62.5%) taking 15 (37.5%) not taking 10 (25%) smokers 30 (75%) non smokers 29 (74.5%) past non-medical treatment 11 (25.5%) no past treatment

Group 2: Individual Treatment (n 40) Female 26 (65%) Male 14 (35%) 45.7 (SD 12.7) 165.7 (SD 18.5) 76.8 (SD 20.8) 10.1 (SD 9.9) 19 (47.5%) constant pain aggravated by movement 21 (52.5%) pain aggravated by movement 23 (57.5%) taking 17 (42.5%) not taking 7 (17.5%) smokers 33 (82.5%) non smokers 28 (70%) past non-medical treatment 12 (30%) no past treatment

Two Physiotherapy Interventions for Chronic LBP Lewis et al 715

Table 3. Within and Between Group Interaction

Group 1 (G1) Exercise Group Mean (SD) Questionnaire score 1. Pre 2. Post 3. 6 months 4. 12 months Lumbar exion 1. Pre 2. Post 3. 6 months 4. 12 months Lumbar extension 1. Pre 2. Post 3. 6 months 4. 12 months Left side exion 1. Pre 2. Post 3. 6 months 4. 12 months Right side exion 1. Pre 2. Post 3. 6 months 4. 12 months Left SLR 1. Pre 2. Post 3. 6 months 4. 12 months Right SLR 1. Pre 2. Post 3. 6 months 4. 12 months Within group interaction paired t test (2-tailed) 2 1 (P 0.002) 23 4 3 (P 0.04) 4 1 (P 0.001) 2 1 (P 0.03) 23 34 4 1 (P 0.03) 21 32 43 4 1 (P 0.02) 2 1 (P 0.05) 32 4 3 (P 0.04) 4 1 (P 0.004) 2 1 (P 0.01) 32 4 3 (P 0.01) 4 1 (P 0.002) 2 1 (P 0.002) 32 43 4 1 (P 0.001) 2 1 (P 0.008) 32 43 4 1 (P 0.004) Group 2 (G2) Individual Treatment Mean (SD) Within group interaction paired t test (2-tailed) (2 1) P 0.001 23 43 4 1 (P 0.001) 2 1 (P 0.004) 23 43 4 1 (P 0.002) 21 32 43 4 1 (P 0.01) 21 32 4 3 (P 0.04) 41 2 3 4 4 1 2 3 1 Between Group Interaction Independent t test (2-tailed)

44.4 (23.1) 32.6 (19.5) 35.4 (23.5) 29.3 (22.6) 31.2 (21.2) 25.2 (19.8) 22.5 (20.9) 22.7 (18.7) 65.2 (7.1) 64.4 (6.8) 64.7 (6.4) 63.2 (6.3) 53.3 (6.0) 51.5 (6.6) 52.6 (6.6) 50.8 (6.3) 53.1 (7.2) 51.2 (7.1) 52.4 (6.4) 50.4 (6.1) 51.7 (19.5) 59.3 (17.9) 61.5 (21.3) 64.3 (19.4) 52.6 (24.9) 59.8 (21.3) 61.1 (21.1) 63.1 (21.8)

34.7 (19.5) 22.3 (18.9) 20.3 (19.1) 19.3 (19.4) 30.3 (21.1) 18.4 (16.9) 18.1 (16.6) 17.8 (14.7) 61.8 (6.7) 57.9 (14.0) 61.3 (5.9) 60.3 (6.1) 50.4 (7.6) 47.1 (11.2) 48.3 (7.8) 47.9 (7.6) 49.2 (7.5) 47.4 (7.2) 47.8 (8.1) 47.9 (7.5) 56.6 (15.8) 60.4 (18.8) 65.6 (19.1) 68.7 (16.1) 57.4 (17.5) 62.9 (19.1) 66.3 (18.9) 69.6 (16.5)

G2 G2 G2 G2

G1 G1 G1 G1

(P (P (P (P NS NS NS NS

0.047) 0.039) 0.008) 0.05)

NS NS G2 G1 (P 0.03) NS NS NS G2 G1 (P 0.02) NS G2 G1 (P 0.024) G2 G1 (P 0.036) G2 G1 (P 0.015) NS NS NS NS NS NS NS NS NS

21 3 2 (P 0.032) 43 4 1 (P 0.001) 12 23 4 3 (P 0.039) 4 1 (P 0.001)

group, and for all movements, except left SLR, in the individual treatment group. All the movements in both groups were greater than the standard error of measurements calculated in the pilot study. Additional Treatment In the exercise group, 3 subjects required additional conservative treatment at the end of their treatment program, 5 at 6 months and 6 at 12 months. At the end of treatment, one subject had additional physiotherapy and another, osteopathy; neither reported improvement. Another subject that had received additional physiotherapy reported improvement at the rst data collection, but reported no change from the pretreatment baseline at 12 months. The 5 subjects receiving additional treatment (physiotherapy, chiropractic, massage) between the second follow-up and the third follow-up, reported no improvement at 6 months. Of the 6 subjects receiving additional treatment (physiotherapy, chiropractic, acupuncture) between 6 to 12 months, one who had received additional physiotherapy reported improvement at 12 months; the others reported no improvement. In comparison, 0, 1, and 2 subjects, respectively, required additional treatment in the individual treatment

group, at the end of treatment, at 6 months and at 12 months. One subject who received additional osteopathy and physiotherapy between the second and third data collection points reported improvement at 6 months. One subject who received additional chiropractic treatment between the third and fourth data collection points reported improvement at 12 months, and another, who had received additional osteopathy during the same period, reported no improvement from the pretreatment baseline. Self-Reported Perception of Change At 12 months, 21 of 33 subjects (63.6%) who had participated in the exercise group felt they had improved, and 12 of 33 (36.4%) felt they remained the same as in the beginning of the study. Of those available at the nal data collection period, no subject reported deterioration. The mean percentage improvement at 12 months was 62.9% (range 20 100%). The corresponding data for the individual treatment group at 12 months was 22 of 29 (75.8%) subjects improved (range 12 to 95%); 7 of 29 (24.1%) remained the same, with no one reporting deterioration.

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Table 4. Within and Between Group Interaction for VAS (Pain)

Group 1 (G1) Exercise Group Mean (SD) Lumbar exion (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Lumbar extension (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Left side exion (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Right side exion (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Left SLR (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Right SLR (VASpain) 1. Pre 2. Post 3. 6 months 4. 12 months Within group interaction paired t test (2-tailed) 2 1 (P 0.03) 32 34 4 1 (P 0.05) 2 1 (P 0.09) 32 4 3 (P 0.02) 4 1 (P 0.03) 2 1 (P 0.03) 32 43 41 21 32 43 4 1 (P 0.002) 21 32 43 4 1 (P 0.01) 2 1 (P 0.04) 32 4 3 (P 0.04) 4 1 (P 0.007) Group 2 (G2) Individual Treatment Mean (SD) Within group interaction paired t test (2-tailed) 2 1 (P 0.002) 32 34 4 1 (P 0.001) 2 1 (P 0.008) 32 43 4 1 (P 0.006) 21 32 43 4 1 (P 0.04) 2 1 (P 0.026) 32 43 4 1 (P 0.001) 2 3 4 4 1 2 3 1 Between Group Interaction Independent t test (2-tailed)

3.5 (2.8) 2.5 (2.3) 2.6 (2.8) 2.3 (2.7) 4.2 (3.2) 3.4 (3.2) 3.5 (2.9) 2.9 (3.0) 3.5 (2.9) 2.5 (2.4) 3.1 (2.8) 2.6 (2.8) 4.1 (2.8) 3.4 (2.8) 3.4 (2.7) 2.6 (2.7) 3.4 (3.1) 3.1 (2.8) 2.7 (2.7) 1.9 (2.5) 3.8 (3.4) 3.1 (2.9) 3.2 (3.1) 2.3 (2.9)

2.9 (2.6) 1.7 (1.8) 1.4 (1.9) 1.3 (1.9) 3.1 (2.9) 2.2 (2.4) 2.0 (2.4) 1.8 (2.5) 2.5 (2.7) 1.8 (2.2) 1.9 (1.9) 1.7 (1.9) 2.9 (2.9) 2.1 (2.4) 1.8 (2.3) 1.5 (1.9) 1.7 (2.0) 1.5 (2.3) 1.1 (1.9) 1.3 (2.2) 2.4 (2.7) 1.2 (2.0) 1.3 (2.2) 1.6 (2.4)

NS NS G2 G1 (P 0.038) NS NS NS G2 G1 (P 0.031) NS NS NS NS NS NS NS G2 G1 (P 0.019) NS G2 G1 (P 0.004) G2 G1 (P 0.021) G2 G1 (P 0.013) NS G2 G1 (P 0.039) G2 G1 (P 0.003) G2 G1 (P 0.01) NS

2 1 (P 0.002) 32 43 4 1 (P 0.028)

Compliance With the Home Exercise Program There was a steady decline in the reported compliance of the home exercises over the 1-year follow-up period. In the exercise group, 29 subjects (87.8%) reported doing their exercises at the end of the treatment period. At 6 months this gure was 69.6% (23 subjects) and 57.5% (19 subjects) at 12 months. There was also a selfreported decline in exercise compliance in the individual treatment group over the 12 month follow-up. At the end of treatment, 25 subjects (86.2%) reported regularly doing their exercise program. At 6 months this gure had reduced to 63% (18 subjects), which was the same number of subjects who self reported continuing their exercises at 12 months. The main reasons given for failing to continue with the exercises were time management and laziness. In both groups, subjects who continued with their home program reported greater improvement than those who had stopped their home exercise program. In the exercise group, 78.9% (15 of 19) still exercising at home reported improvement at the end of the 12 months. In comparison, 64.3% (9 of 14) subjects who had stopped their home program in this group reported improvement. Similarly, in the individual treatment group, 83.3% (15 of 18) of subjects who were still exercising at home at 12 months reported improvement, whereas 63.6% (7 of 11) of those not exercising reported improvement. 2 analy-

sis of subjects exercising (yes/no) and improvement at 12 months (yes/no) for the individual treatment failed to achieve statistical signicance (2 1.6, df 1). In contrast, those in the exercise group did achieve statistical signicance (2 10.4, df 1, P 0.001 two-tailed). Subjects who completed the exercise group and who were still exercising at 12 months also reported a statistically signicant improvement in their condence (2 5.46, df 1, P 0.01 two-tailed). In contrast those still exercising in the individual treatment group failed to achieve a statistically signicant improvement of their condence (2 2.4, df 1). Behavior of Pain and Duration of Symptoms There was no statistically signicant relationship between the behavior of the subjects pain at the beginning of the study and their self reported improvement (group 1: 2 0.8, df 1; group 2: 2 1.4, df 1), or condence (group 1: 2 0.2, df 1; group 2: 2 2.8, df 1), at 12 months for either group. The correlation between duration of symptoms before commencement of treatment, and the score at 12 months for percentage improvement, lumbar exion, extension, left and right side exion, left and right straight leg raise, and their corresponding VAS(pain) scores was analyzed using the Kendall correlation coefcient. The analysis failed to

Two Physiotherapy Interventions for Chronic LBP Lewis et al 717

Table 5. The Relationship Between Smoking and Outcome

Group 1: 10 Smokers (3 Male, 7 Female) Mean 14.2, Cigarettes/Day Range (320) Improved Questionnaire score at 12 months Nonsmokers Smokers Subjective improvement at 12 months Nonsmokers Smokers Condence at 12 months Nonsmokers Smokers Same Worse Group 2: 7 Smokers (2 Male, 5 Female) Mean 14.6, Cigarettes/Day Range (220) Improved Same Worse

76.0% 62.5% 68.0% 50.0% 76.0% 50.0% Yes 20.0% 37.5%

24.0% 37.5% 32.0% 50.0% 4.0% 12.5% No 44.0% 62.5% 80.0% 37.5%

96.2% 100% 74.0% 33.0% 81.5% 33.3% Yes 69.2% 0.0% 19.2% 33.0% 11.1% 0.0%

3.8% 0.0% 26% 66.0% 7.4% 66.7% No 30.8% 100% 80.8% 66.0%

Exercising at 12 months Nonsmokers Smokers Analgesic use at 12 months Nonsmokers Smokers

56.0% 37.5% 20.0% 62.5%

demonstrate any statistically signicant correlation (at the 5% level) for any pairs, in either group of subjects. Analgesic Requirements In the exercise group, 62.5% (25 of 40) of subjects were taking analgesics at the beginning of the program. At the nal data collection, this had reduced to 30.3% (13 of 33). The corresponding data for the individual treatment group was 57.5% (23 of 40) subjects taking medication for LBP relief at the start of the study and 20.6% (6 of 29) at the end of the study. Although a trend appeared to exist between exercise and reduced analgesic use, a 2 analysis of subjects exercising (yes/no) and taking analgesics (yes/no) for the exercise group failed to achieve statistical signicance (2 1.8, df 1). The same analysis for the individual treatment group also failed to achieve statistical signicance (2 0.47, df 1). Level of Fitness Before starting the exercise group intervention, 8 subjects (20%) perceived their tness level to be very poor, 12 (30%) poor, 19 (47.5%) average, 1 (2.5%) good, and none excellent. At the 12-month stage there was a general trend of improvement with 3 subjects (9.1%) very poor, 7 (21.2%) poor, 18 (54.5%) average, 4 (12.1%) good, and 1 (3%) excellent. In comparison, 6 subjects (15%) participating in the individual treatment reported their tness level to be very poor, 10 (25%) poor, 19 (47.5%) average, and 5 (12.5%) good. At the 12-month Table 6. Alternative Analysis
Group 1 (%) Improved End of treatment 6 months 12 months 50.0 47.5 52.5 Same 47.5 35 30

stage, 1 subject (3.4%) reported a very poor level of tness, 3 (10.3%) poor, 18 (62.1%) average, and 7 (24.1%) good. The Relationship Between Smoking and Outcome Table 5 details the relationship between the participants who smoked throughout the study and outcome. Alternative Analysis In this study, the data from each participant was analyzed in accordance with the intention-to-treat approach. It is possible that missing subject data represented deterioration in the subjects LBP symptoms. Therefore an analysis was also performed in which it was assumed that missing values represented subjects who had dropped out because of deterioration in their condition or an expectation that they would no benet from the assigned therapy. Table 6 details the results of this alternative analysis, the results of which substantially reduce the benet of the intervention for subjects allocated to the individual treatments and, to a lesser extent, for those randomized to the exercise group. Discussion Improvement and restoration of function is a primary aim for physiotherapy rehabilitation for patients with CLBP. Disability questionnaires are key tools to determine the response to treatment as they provide information about a wide range of functional tasks. The Quebec

Group 2 (%) Worse 2.5 17.5 17.5 Improved 65 55 55 Same 7.5 17.5 17.5 Worse 27.5 27.5 27.5

718 Spine Volume 30 Number 7 2005

Disability Questionnaire has been shown to be a useful tool in assessing and monitoring change in the function of CLBP patients.23,28 There was a statistically signicant reduction in questionnaire scores in both groups. The mean decrease in the exercise group was 15.1 and the corresponding result in the individual treatment group was 15.4. Both groups achieved the minimum clinically important difference necessary as recommended by Fritz and Irrang.23 The ndings suggests that both forms of intervention produce similar clinically important reductions in symptoms. Overall, in comparison to the individual treatment group, fewer subjects in the exercise group reported improvement at 12 months. This may have been attributable to the higher disability scores of the exercise group at the commencement of the study. In contrast, similar results regarding self-reported perception of improvement were found for both groups for the subjects who had continued their exercise program. The relationship between exercise compliance and self-reported perception of improvement achieved statistical signicance in the exercise group but not in the individual treatment group. Knowledge of the condence a patient has to move and use their spine during daily activities is important because pain-related fear is associated with avoidance behaviors as well as kinesophobia.4,29,30 Subjects in the exercise group who continued to exercise reported feeling more condent about their back during daily functional activities at the nal data collection point, and this clinically signicant nding also achieved statistical signicance, whereas it failed to achieve statistical significance in the individual treatment group. It is frequently difcult for the clinician to predict an outcome based on a patients presenting symptoms. The ndings of this study suggested that no statistical correlation existed between initial pain behavior (intermittent/constant) and any of the commonly used physical range-of-movement assessment procedures in this group of patients. These ndings suggest that the majority of patients who present to an out-patient physiotherapy department with mechanical nonspecic LBP (without radiation), independent of pain behavior, movement restriction, and duration of symptoms, and who continue to exercise at the completion of the formal treatment period, can expect an improvement in their perception of pain, condence, and range of movement. They may also expect a reduction in their disability. These same ndings can be expected in the individual treatment group but will not reach statistical signicance for self perception of improvement and condence. Analgesic requirements were reduced in both groups. Although this relationship failed to achieve statistical signicance, it is clinically relevant with regard to pain behavior, potential side effects, and healthcare costs. Similarly, OSullivan et al11 reported that analgesic requirements were reduced in subjects who completed a specic stabilization exercise program in comparison to subjects who received conventional

medical care. In general, at 12 months subjects in both groups reported that their level of tness had improved. In both groups, 5 fewer subjects reported their level of tness to be very poor. In the exercise group, there were 5 fewer subjects who reported their tness to be poor and 1 less in the average band. In comparison, 7 fewer subjects in the individual treatment group reported their tness level to be poor and 1 less in the average category. Three more subjects in the exercise group, and 2 more in the individual treatment group reported their tness levels to be good, and 1 subject in the exercise group reported their tness to be excellent. Although, it was beyond the resources of this study to investigate the physiologic levels of tness at the beginning and end points of the investigation, it is possible that these changes in the perception of tness levels may have been associated with the other ndings, such as self perception of improvement, condence, disability scores, and possibly increases in range of movement. No consensus was found in this study regarding the efcacy of one form of treatment over the other. This nding supports other studies that have investigated different forms of treatment intervention and that have reported favorable results with various interventions. Johannsen et al13 compared a combination of strengthening and endurance exercises and endurance and coordination exercises in patients with CLBP. At the 6-month follow-up point, they reported that both groups had an equal reduction in symptoms. Klaber Moffet et al31 reported that a general exercise program involving low impact aerobics, generalized strengthening aimed at all the major muscle groups, relaxation exercises, and stretching was signicantly more effective at 6 and 12 months in a group of 187 patients with subacute to chronic mechanical LBP than traditional medical management. Hides et al10 compared medical care (bed rest, medication advice) with 8 treatments involving specic spinal stabilization exercises for patients with acute LBP. Each subject completed a telephone questionnaire with regard to their subjective recollection of LBP recurrence, severity, and additional treatment at 1 year and between 2 and 3 years after intervention. At 1 year, 6 of 20 subjects in the exercise group (30%) and 16 of 19 (84%) in the medical care group had reported a recurrence of pain. At 3 years, the ndings were 9 of 20 and 16 of 19, respectively. Eight out of 19 (42%) subjects in the medical care group reported seeking additional treatment in the rst year, and 4 of 16 (25%) in years 2 to 3. The corresponding gures for the specic exercise group were 3 of 20 (15%) and 4 of 20 (20%), respectively. Cairns et al17 compared conventional physiotherapy (dened as any physiotherapy technique currently in clinical use, excluding high repetition/low load trunk training) and specic spinal stabilization exercises and conventional physiotherapy. At the 6 month follow-up point, both groups had improved, and there was no signicant difference between the groups for the outcome measurements of

Two Physiotherapy Interventions for Chronic LBP Lewis et al 719

interest (Roland Morris Disability Questionnaire, Distress Risk Assessment Method, McGill pain questionnaire (short-form), numerical rating score of usual pain). It is difcult to directly compare ndings between these studies10,17 as the effect of general exercises was not investigated by Hides et al,10 and follow-up time and patient selection was not comparable. However, it appears that both forms of exercise intervention were benecial in the management of LBP and that the inclusion of specic spinal stabilization exercises may not be essential in the management of nonspecic CLBP.8,17,18,31 This supports the ndings of Brox et al32 after a review of exercise and manipulation in the treatment of LBP who reported that studies comparing the effectiveness of different exercise regimens have found no evidence in favor of one particular method. Koes et al18 reported that manual therapy produced a faster and larger improvement in patients with CLBP in comparison with exercise, massage and electrotherapy, placebo, and medical treatment. Mobilization was reported to be the most common intervention used in the treatment of LBP by physiotherapists in Britain and Ireland with 59% of respondents (n 813) using Maitland mobilizations.33 Aure et al8 compared manual therapy and exercise therapy (n 27) with exercise therapy alone (n 22) in a group of CLBP patients. Although signicant improvement was observed in both groups, the manual therapy group demonstrated signicantly larger improvements than the exercise therapy in all outcome variables throughout the entire study. This nding suggests that the inclusion of manual therapy for this group of patients is benecial, and the effect is greater than exercise alone, and these ndings support the results of other studies investigating the role of mobilization in chronic LBP.16,18 In the present study there was no signicant difference between the 2 groups in the magnitude of the main outcome measurement. To our knowledge this is the rst study that reports the use of mobilization therapy as one of the stations in a group exercise program, and the difference in outcome between the current study and that reported by Aure et al8 may in part be attributable to the inclusion of mobilization in both treatment groups. Further research is necessary to determine the role and effect of mobilization therapy for patients with CLBP. The benecial effects of both forms of manual therapy and exercise therapy reported in the literature and in the present study may be explained by improved nutrition of the intervertebral disc induced by motion.34 In addition, both the mobilization and exercise may have released endorphins that modify the perception of pain.35 This may be a generic effect common to many forms of treatment and may explain the preponderance of manual techniques with a similar physical action (e.g., mobilization, trigger point therapy, acupressure massage). It may also help explain the apparent benecial effect derived from specic spinal stabilization and general exercises in this patient group.

Smoking There were 10 smokers in the exercise group (7 females and 3 males) who smoked an average of 14.2 cigarettes each day (range 320). At the 12 month assessment, there were 8 still smoking whose data were available for analysis. Of those smoking 3 of 8 (37.5%) had a worse questionnaire score, and 5 of 8 (62.5%) had an improved score. In comparison, 76% (19 of 25) of the nonsmokers had an improved questionnaire, and 6 of 25 (24%) had deteriorated. Fifty percent (4 of 8) of the smokers felt they had subjectively improved over the 12-month period in comparison with 68% (17 of 25) of the nonsmokers. At 12 months, one smoker felt less condent about their back (12.5%), with 3 of 8 (37.5%) feeling the same as at the beginning of the study and 4 of 8 feeling more condent. In comparison, 76% (19 of 25) of the nonsmokers felt more condent, 5 of 25 (20%) felt the same level of condence, and 1 of 25 (4%) felt less condent. More smokers (5 of 8, 62.5%) reported that they were still doing their exercises at 12 months in comparison to the nonsmokers (11 of 25, 44%). At 12 months 5 of 8 smokers (62.5%) were still taking analgesic medications, whereas 20% (5 of 25) of the nonsmokers still required analgesic cover for their LBP. At 12 months no smoker perceived their level of tness to be greater than average [3 of 8 (28%) poor, 5/8 (62.5%) average]. In comparison, 7 of 25 (28%) of the nonsmokers perceived their tness to be poor, 13 of 25 (52%) average, 4 of 25 (16%) good, and 1 of 25 (4%) excellent. The majority of smokers in the individual treatment group had withdrawn from the study or were lost to follow-up by the second data collection period. There were 7 smokers (5 women and 2 men) in this group at the beginning of the study. They smoked a mean 14.6 cigarettes each day (range 2 40). There were only 3 smokers present at the end of treatment, 6 month and 12 month follow-up. At 12 months, all three had an improved questionnaire score, one felt more condent about his/her back, and two less condent. None reported doing their exercises at 12 months in comparison with 18 of 26 (69.2%) of nonsmokers who were still exercising. One of the smokers (33.3%) still required analgesic cover, and the other two did not. In comparison 5 of 26 of the nonsmokers (19.2%) required analgesics for their back pain. At the nal data collection point, two smokers reported their tness level to be poor (66.6%) and one average (33.3%). In comparison 1 of 26 (3.8%), 2 of 26 (7.7%), 16 of 26 (61.5%), 7 of 26 (26.9%), of the nonsmokers reported their tness levels to be very poor, poor, average, and good, respectively. From a simple statistical analysis it appears that smoking was less of a problem in the individual treatment group. However, this nding would appear to be heavily biased because the majority of the smokers had left the study before the second data collection was complete. Although a number of studies have not found a relationship between smoking and LBP,36,37 others have reported a denite relationship between smoking and LBP,38,39 whereas a modest effect

720 Spine Volume 30 Number 7 2005

has been reported in other investigations.40 These equivocal ndings relate primarily to the lack of longitudinal studies and are also inuenced by confounding variables within the reported studies. Although the present study lacks sufcient power to substantially contribute to this knowledge base, the apparent negative association with smoking, especially in the exercise group, is potentially of relevance. Fogelholm and Alho41 have hypothesized how smoking leads to lumbar pathology, and Lincoln et al39 have suggested that modiable health behaviors such as smoking are relevant targets for intervention in musculoskeletal disease. It may therefore be relevant for physiotherapists who are treating patients individually or in group settings to discuss these issues with their patients. Economic Analysis of the Treatments The individual treatment (group 2) cost was determined to be 40% higher than the exercise group treatment (group 1) cost. This is based on the hourly rate for a senior physiotherapist working for the National Health Service (NHS) who on the midpoint of their pay scale would currently earn approximately 15 per hour. On this basis, the cost of running the exercise group (group 1) for 10 patients over 8 weeks, for 8 hours of therapy by 3 physiotherapists would be 360. In comparison, for one physiotherapist to treat 1 patient 8 times, the cost would be 60 (8 30 minute sessions). To treat 10 patients, the cost would be 600 or 240 more than the exercise group for the same number of patients. This does not take into account electricity and other associated costs that are assumed to be roughly equal. In Britain in 1993, physiotherapists assessed 1.3 million new patients with back pain. This was associated with a mean total of approximately 14.2 million treatment sessions. The overall cost of physiotherapy (NHS and private) was 207 million. The cost to the NHS was reported to be 63 million.7 In our department we see approximately 3000 new referrals annually for CLBP. The cost to the department of treating these patients individually (mean 8 treatments) is approximately 180,000. Using the group approach, the approximate cost would be 108,000, a savings of 72,000. Our current practice is for specialist physiotherapists to triage all LBP patients entering the hospital, performing physical and psychosocial assessments, identifying red and yellow ags, and then determining who should be referred for investigations (blood screening, radiograph, bone scans, MRI, computed tomography, etc.), surgical consultation, pain management team treatment, individual physiotherapy treatment, hydrotherapy, or the CLBP exercise group. The group continues to consist of eight 1-hour sessions but is preceded by eight 30 minute lectures including the following: anatomy and biomechanics of the spine; neurophysiology of pain; pacing, goal-setting, and managing a are-up; ergonomics; role of exercise in CLBP; relaxation techniques; well being (diet, nutrition, smoking, hobbies); and questions and discussion.

In this study patients were instructed and encouraged to continue exercises at home. Each patient was given an exercise diary but 5% of both groups completed it, and it was not used in the nal analysis. Lack of time, forgetfulness, and laziness were the main reasons given for not completing the diary. As such there was no control on the type, frequency, or duration of the home exercise program available for the data analysis. Another limitation of this study was the lack of a control and placebo group. To some extent this may have been offset by the mean duration of symptoms (11.1 and 10.1 years for the exercise group and individual treatment group, respectively). This pragmatic approach to research on the effects of conservative treatment for chronic LBP has been used in other studies.8,13,17 Where placebo and control groups have been included in the study design,10,18,31 the ndings have demonstrated a signicant improvement in favor of the active intervention. Further studies are required to determine whether the improvement observed in this study occurred as a result of the possible natural resolution of an exacerbation of LBP or as a result of the intervention. CLBP is associated with decreased spinal range of movement.42 Although this association has been challenged,43 the ndings of the current study suggest that a decrease in disability was associated with an improvement in range of movement. Further studies are required to determine whether reduced mobility is associated with CLBP, and if it is, whether it is a cause or symptom of the condition. Conclusion Different models have been proposed for the treatment of CLBP, but no one method appears to be more effective than another. The ndings of this study suggest that similar results are likely using either an individual treatment or a group exercise approach, with up to 78% of participants expressing improvement, 12-months after the conclusion of the intervention. Exercise compliance, selfreported improvement, and improvement in condence achieved statistical signicance for those patients treated using the group approach but failed to do so for those patients treated individually. Furthermore, the cost of the group treatment was substantially lower than the individual treatment approach, and if future research supports these ndings, then this potential savings could be used to support other aspects of the health service generally, and the physiotherapy service specically. Key Points
Patients with chronic low back pain were randomized to receive individual physiotherapy treatment or a group exercise treatment. Both forms of intervention were found to be statistically and clinically effective in the management of chronic low back pain disability.

Two Physiotherapy Interventions for Chronic LBP Lewis et al 721

19. Mulligan BR. Manual Therapy Nags, Snags, MWMs, etc. 4th ed. New Zealand: Plane View Services; 1999. 20. Vicenzino B, Collins D, Wright A. The initial effects of a cervical spine manipulative physiotherapy treatment on the pain and dysfunction of lateral epicondylalgia. Pain 1996;68:69 74. 21. Vicenzino B, Collins D, Benson D, et al. An investigation of the interrelationship between manipulative therapy-induced hypoalgesia and sympathoexcitation. J Manipulative Physiol Ther 1998;21:448 53. 22. Wright A. Hypoalgesia post-manipulative therapy; a review of potential neurophysiological mechanisms. Man Ther 1995;1:11 6. 23. Fritz JM, Irrgang JJ. A comparison of a modied Oswestry low back pain disability questionnaire and the Quebec back pain disability scale. Phys Ther 2001;81:776 88. 24. Kopec JA, Esdaile JM, Abrahamowicz M, et al. The Quebec Back Pain Disability Scale. Measurement properties. Spine 1995;20:34152. 25. McKenzie R. Treat Your Own Back. New Zealand: Spinal Publications New Zealand Limited; 1998. 26. OSullivan PB. Lumbar segmental instability: clinical presentation and specic stabilizing exercise management. Man Ther 2000;5:212. 27. Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. Stamford, CT: Appleton and Large, 1993. 28. Davidson M, Keating JL. A comparison of ve low back disability questionnaires: reliability and responsiveness. Phys Ther 2002;82:8 24. 29. Picavet HSJ, Vlaeyen JWS, Schouten JSAG. Pain catastrophizing and kinesophobia: Predictors of chronic low back pain. Am J Epidemiol 2002;156: 1028 34. 30. Waddell G. The back pain revolution. Edinburgh, UK: Churchill Livingstone, 1998. 31. Klaber Moffett J, Torgerson D, Bell-Syer S, et al. Randomised controlled trial of exercise for low back pain: clinical outcomes, costs and preferences. BMJ 1999;319:279 83. 32. Brox JI, Hagen KB, Juel NG, et al. Is exercise therapy and manipulation effective in low back pain? Tidsskr Nor Laegeforen 1999;119:204250. 33. Foster NE, Thompson KA, Baxter GD, et al. Management of nonspecic low back pain by physiotherapists in Britain and Ireland. Spine 1999;24:1332 42. 34. Holm S, Nachemson A. Variation in the nutrition of the canine intervertebral disc induced by motion. Spine 1983;8:866 74. 35. Fields HL. Sources and variability in sensation of pain. Pain 1988;33:195 200. 36. Kovacs FM, Gestoso M, Gil del Real MT, et al. Risk factors for non specic low back pain in schoolchildren and their parents: a population based study. Pain 2003;103:259 68. 37. Mortimer M, Wiktorin C, Pernol G, et al. Sports activities, body weight and smoking in relation to low back pain: a population-based case referent study. Scand J Med Sci Sports 2001;11:178 84. 38. Kostova V, Koleva M. Back disorders and some related risk factors. J Neurol Sci 2001;192:1725. 39. Lincoln AE, Smith GS, Amoroso PJ, et al. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work 2002;18:99 113. 40. Power C, Frank J, Hertzman C, et al. Predictors of low back pain onset in a prospective British study. Am J Public Health 2001;91:1671 8. 41. Fogelholmn RR, Alho AV. Smoking and intervertebral disc degeneration. Med Hypotheses 2001;56:5379. 42. Mellin G. Correlation of spinal mobility with degree of chronic low back pain after correction for age and anthropometric factors. Spine 1987;12: 464 8. 43. Parks KA, Crichton KS, Goldford RJ, et al. A comparison of lumbar range of motion and functional ability scores in patients with low back pain. Spine 2003;28:380 4.

Group exercise treatment resulted in a statistically signicant improvement in condence. The cost of the group exercise approach was found to be substantially lower than the individual treatment approach.

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