An interventional study of Motor control exercises and Graded activity in Chronic Low Back Pain and Non Specific Low Back Pain, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
Among 36 studies in Motor Activity by McMaster University — 4 open to participants now, 6 under way, 1 of them phase 3. Motor Activity · McMaster University.
Among the 36 studies in Motor Activity by McMaster University, this one is the 29th largest by enrollment of the 35 interventional ones that give a count, is one of 5 that started in 2017, is one of 32 with no phase, and was the 17th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →4 of the 36 studies in Motor Activity by McMaster University are open now, in 2 countries. Recruiting first, the newest first:
McMaster University · Sites in Canada
McMaster University · Sites in Canada
McMaster University · Sites in United States, Canada
McMaster University · Sites in Canada
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2017.
This study's enrollment of 20 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 36 across the 35 interventional studies, 114 across the 1 observational. Of the 30 that completed or were terminated, 3 (10%) have results posted.
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McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
1 of the studies in Motor Activity by McMaster University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07912307McMaster UniversitySex Differences in BDNF Study | 2027-02 |
Among the 36 studies in Motor Activity by McMaster University, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A primary goal of the motor control exercise program is to regain control and coordination of the spine and pelvis using principles of motor learning such as segmentation and simplification. The whole intervention is based on assessment of the individual patient's motor control impairments and the patient's individual treatment goals (set collaboratively with the therapist).
Behavioral: Motor control exercises
A primary goal of the graded activity program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. The intervention uses cognitive behavioral approaches to deal with fear of movement and self efficacy.
Behavioral: Graded activity
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.
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.
Patient Specific Functional Scale
This scale evaluates patient's self function on a scale from 0-10.
Time frame: 12 months
Patient Specific Functional Scale
This scale evaluates patient's self reported function on a scale from 0-10
Time frame: 2 and 6 month
Roland Morris Disability Questionnaire
The RMDQ questionnaires evaluates pain related disability on a scale from 0-24.
Time frame: 2, 6 and 12 months
Numeric Rating Scale- pain
A numeric rating scale from 0-10 will be used to assess average level of pain over the last week
Time frame: 2, 6 and 12 months
SF-36
The SF-36 will be used to assess self reported quality of life
Time frame: 2, 6 and 12 months
Effect Modifier - OREBRO
OREBRO LBP screening questionnaire is a 24 item scale to measure psychosocial risk factors for poor outcomes (scale from 11 to 192)
Time frame: baseline
Effect modifier _ Lumbar instability
Lumbar Spine Instability Questionnaire is a self reported scale to evaluate clinical instability on a scale from 0-15.
Time frame: baseline
Effect modifier _ Kinesiophobia
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
Time frame: baseline
Effect modifier_ Coping
Coping Strategies Questionnaire is a 6 item measure of coping in patients with chronic pain (00-36)
Time frame: baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Sep 2018, 20 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 20 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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