Chronic Low Back Pain, Non Specific Low Back Pain
Conditions
Keywords
exercise, mobility, physiotherapy, validation
Brief summary
Dr. Macedo and others involved in the proposed research recently conducted a study that investigated whether simple clinical characteristics could identify patients who benefit more from either motor control exercises or graded activity. Results were statistically significant and clinically relevant demonstrating that a simple questionnaire could help aid the selection of the most appropriate exercise therapy for each individual patient. Therefore, we aim to conduct a randomized controlled trial following a similar approach to the original study to validate in a different sample the results of the effect modification analysis.
Detailed description
Dr. Macedo and others involved in the proposed research recently conducted a study that investigated whether simple clinical characteristics could identify patients who benefit more from either motor control exercises or graded activity. Motor control exercises (sometimes called lumbar stabilization exercises) and graded activity using the principles of cognitive behavioral therapy are two popular forms of exercise therapy with evidence of effectiveness from high quality systematic reviews, but no evidence for superiority of one approach over the other when tested in heterogenous populations. The results of a previously published study demonstrated that a simple 15-item questionnaire (Lumbar Spine Instability (LSI) Questionnaire) could identify patients who responded best to either motor control exercise or graded activity (interaction 2.72 95% CI 1.39 to 4.06, p=0.001). The results demonstrated that for people who are LSI negative, graded activity provided a much better outcome than motor control exercise one year post-intervention (a statistically and clinically significant improvement of 1.96 points on a 0-10 numeric function scale; p\< 0.001). In people who were LSI positive, motor control exercise provided slightly better outcomes, compared to those prescribed motor control exercises. It is important to note that this study was measuring differences between treatments groups, and thus change in the scores of function presented represent differences between groups. However, although this clinical decision rule has the potential to transform exercise treatment for LBP, especially given the relatively large interaction effects found, validation in an independent sample is essential before recommending use in clinical practice.There are three recognized steps in developing clinical decisions rules: derivation, validation and impact evaluation. Dr. Macedo's previous study falls within the first step of this process and the proposed study aims to address the second step; validation. Therefore, the objective of this study is to conduct a randomized controlled trial following a similar approach to the original study to validate in a different sample the results of the effect modification analysis to identify baseline characteristics that predict/modify response to treatment.
Interventions
BEHAVIORALMotor control exercises
The first stage of the treatment involves assessment of symptoms and implementation of a retraining program designed to improve activity of muscles assessed to have poor control and reducing activity of any muscle identified to be overactive. Participants are taught how to contract these muscles independently from the superficial trunk muscles and progress until the patient are able to maintain isolated contractions of the target muscles. During this stage exercises for breathing control, posture of spine and lower limb and movement are performed. The second stage of the treatment involved the progression of the exercises towards more functional activities. Throughout this process the recruitment of the trunk muscles, posture, movement pattern and breathing are assessed and corrected.
BEHAVIORALGraded activity
The program is based on activities that each patient identify as problematic and that they cannot perform or have difficulty performing because of their back pain. The activities in the program are progressed in a time-contingent manner from the baseline assessed ability to a target goal set jointly by patient and therapist. Patients receive daily quotas and are instructed to only perform the agreed amount, even when they feel they are capable of doing more. Cognitive-behavioural principles are used to help patients overcome the natural anxiety associated with pain and activities. Physiotherapists use positive reinforcement, explain pain mechanisms and addressed negative behaviours and pain-related anxiety. A plan for managing relapses is developed between therapists and patients.
Sponsors
University of Alberta
Macquarie University, Australia
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Given that this is an exercise study blinding of participants and those delivering the exercise program will not be possible. Outcome measures will be collected by an investigator not aware of treatment allocation, but most outcome measures will be self-reported and thus, true assessor blinding will no be possible. All statistical analysis will be conducted by a blinded investigator.
Intervention model description
Participants will be randomized into one of two groups, both of which are exercises considered part of standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible for inclusion if they meet all of the following inclusion criteria: chronic non-specific LBP (\>3 months) with or without leg pain, currently seeking care for LBP, between 18 to 80 years of age, English speaking (to allow response to the questionnaires and communication with the treating physiotherapist), Clinical assessment indicating that the participant is suitable for active exercises (by a family physician or using the Physical Activity Readiness Questionnaire), Moderate or greater pain or disability measured using question 7 or question 8 of the SF-36 Health Survey, moderate or High Risk Classification on the STarT Back Tool indicating appropriateness of physiotherapy and thus an exercise program.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Functional Scale | 12 months | This scale evaluates patient's self function on a scale from 0-10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Functional Scale | 2 and 6 month | This scale evaluates patient's self reported function on a scale from 0-10 |
| Roland Morris Disability Questionnaire | 2, 6 and 12 months | The RMDQ questionnaires evaluates pain related disability on a scale from 0-24. |
| Numeric Rating Scale- pain | 2, 6 and 12 months | A numeric rating scale from 0-10 will be used to assess average level of pain over the last week |
| SF-36 | 2, 6 and 12 months | The SF-36 will be used to assess self reported quality of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect modifier _ Lumbar instability | baseline | Lumbar Spine Instability Questionnaire is a self reported scale to evaluate clinical instability on a scale from 0-15. |
| Effect modifier _ Kinesiophobia | baseline | Pain Anxiety Symptom Scale (PASS - 20) is a scale used in chronic pain to evaluate kinesiophobia, anxiety and depression symptoms associated with pain experience. Scores are divided into cognitive (0 to 5), escape/avoidance (0 to 5), fear (0 to 5) and psychological anxiety (0 to 5). Total score from 0-100 |
| Effect modifier_ Coping | baseline | Coping Strategies Questionnaire is a 6 item measure of coping in patients with chronic pain (00-36) |
| Effect Modifier - OREBRO | baseline | OREBRO LBP screening questionnaire is a 24 item scale to measure psychosocial risk factors for poor outcomes (scale from 11 to 192) |
Countries
Canada
Outcome results
None listed