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Which Exercise for Low Back Pain: A Validation Study

This study is not yet open for participant recruitment.
Verified October 2017 by Luciana Macedo, McMaster University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03327753
First Posted: October 31, 2017
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Alberta
Macquarie University, Australia
Information provided by (Responsible Party):
Luciana Macedo, McMaster University
  Purpose
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.

Condition Intervention
Chronic Low Back Pain Non Specific Low Back Pain Behavioral: Motor control exercises Behavioral: Graded activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized into one of two groups, both of which are exercises considered part of standard care.
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.
Primary Purpose: Treatment
Official Title: Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain: a Validation Pilot Study

Resource links provided by NLM:


Further study details as provided by Luciana Macedo, McMaster University:

Primary Outcome Measures:
  • Patient Specific Functional Scale [ Time Frame: 12 months ]
    This scale evaluates patient's self function on a scale from 0-10.


Secondary Outcome Measures:
  • Patient Specific Functional Scale [ Time Frame: 2 and 6 month ]
    This scale evaluates patient's self reported function on a scale from 0-10

  • Roland Morris Disability Questionnaire [ Time Frame: 2, 6 and 12 months ]
    The RMDQ questionnaires evaluates pain related disability on a scale from 0-24.

  • Numeric Rating Scale- pain [ Time Frame: 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 [ Time Frame: 2, 6 and 12 months ]
    The SF-36 will be used to assess self reported quality of life


Other Outcome Measures:
  • Effect Modifier - OREBRO [ Time Frame: baseline ]
    OREBRO LBP screening questionnaire is a 24 item scale to measure psychosocial risk factors for poor outcomes (scale from 11 to 192)

  • Effect modifier _ Lumbar instability [ Time Frame: baseline ]
    Lumbar Spine Instability Questionnaire is a self reported scale to evaluate clinical instability on a scale from 0-15.

  • Effect modifier _ Kinesiophobia [ Time Frame: 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 [ Time Frame: baseline ]
    Coping Strategies Questionnaire is a 6 item measure of coping in patients with chronic pain (00-36)


Estimated Enrollment: 172
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motor control exercises
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
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.
Experimental: Graded activity
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 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Exclusion criteria will be known or suspected serious pathology, comorbidity that would prevent participation in exercise programs and scheduled for surgery during trial period.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327753


Contacts
Contact: Luciana Macedo, PhD 905-525-9140 ext 22910 macedol@mcmaster.ca

Sponsors and Collaborators
McMaster University
University of Alberta
Macquarie University, Australia
Investigators
Principal Investigator: Luciana Macedo, PhD McMaster University
  More Information

Responsible Party: Luciana Macedo, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03327753     History of Changes
Other Study ID Numbers: WhichEx2017
First Submitted: October 23, 2017
First Posted: October 31, 2017
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luciana Macedo, McMaster University:
exercise
mobility
physiotherapy
validation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms