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Which Exercise for Low Back Pain? Predicting Response to Exercise for Patients With Low Back Pain

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.
 
ClinicalTrials.gov Identifier: NCT04283409
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Macquarie University, Australia
Laval University
The University of Queensland
University of Alberta
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Exercise therapy is the most recommended treatment for chronic low back pain. There is a wide range of exercises available and research studies have shown that no exercise is superior to another. The problem is that the effects of exercise in reducing pain and disability are small to moderate. Researchers and clinicians believe that different patients may best respond to different types of exercises. This means that if patients could be better matched to specific exercises, then the effects of exercise would be greater. A study conducted by the investigators of this study tested whether patient's characteristics could predict outcomes to two of the most common exercises for low back pain: motor control exercises or graded activity. The results showed that a simple questionnaire (Lumbar Spine Instability Questionnaire) could identify patients who responded best to either exercise. Patients with low clinical instability (measured by the questionnaire) responded best to graded activity. Patients with high clinical instability responded best to motor control exercises.These results were the first to show that better matching patients to specific exercises improves outcomes. Although these results have the potential to significantly improve the delivery of exercises for low back pain, validation of the results in a high-quality study with a large group of patients is a prerequisite to clinical implementation. The aim of this study is to conduct a randomized controlled trial comparing the effects of graded activity to motor control exercises and identify groups of respondents to these exercises. The study will also include the evaluation the costs and benefits of these interventions and the potential impact of matched treatment to patients and the health care system. The results of this study has the potential to increase the effects of exercise in low back pain and consequently lead to better patient outcomes and decreased health related costs.

Condition or disease Intervention/treatment Phase
Non-specific Low Back Pain Other: Graded activity Other: Motor Control Exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Given the exercise nature of the study it is not possible to blind therapists or patients, however; assessors will remain blinded
Primary Purpose: Treatment
Official Title: Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain - a Validation Randomized Controlled Trial
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motor Control Exercise
The primary goal of motor control exercises is to retrain optimal control and coordination of the spine. It uses principles of motor learning such as segmentation, simplification and task-specific practice to retrain control of trunk muscles activation, alignment and movement. The first stage of the treatment involves assessment of the postures, movement patterns and muscle activation associated with symptoms and a retraining program designed to improve activity of muscles assessed to have poor control (usually the deep trunk muscles). Participants are taught how to contract these muscles independently. During this stage additional exercises for breathing control, posture of spine and movement are performed. The second stage of the treatment involves the progression of the exercises towards functional activities, firstly using static then dynamic tasks. Education is also included.
Other: Motor Control Exercises
Exercise therapy using principles of motor control and motor learning and education

Experimental: Graded Activity
The primary goal of graded activity is to address individual modifiable contextual factors associated with the pain experience such as self-efficacy, pain-related fear, kinesiophobia and unhelpful beliefs/behaviors about back pain while at the same time addressing physical impairments such as endurance, muscle strength and balance. A primary goal of the program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. 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. Cognitive-behavioral principles are used to help patients overcome the natural anxiety associated with pain and activities.
Other: Graded activity
Exercise therapy using principles of cognitive behavioral therapy and education




Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 2 months ]
    disease specific disability questionnaire; total score from 0-100 (higher scores represent worse disability)


Secondary Outcome Measures :
  1. Patient Specific Functional Scale [ Time Frame: 0, 2, 6 and 12 months ]
    Rate 3 problematic activities; average of the 3 activities generate a total score from 0-10 (lower scores represent worse function)

  2. Pain Numeric Ranting Scale [ Time Frame: 0, 2, 6 and 12 months ]
    Pain over the last week; total score from 0-10 (higher scores represent worse pain)

  3. EQ-5D-5L [ Time Frame: 0, 2, 6 and 12 months ]
    Health related quality of life; index score form 0-100 (lower scores represent lower quality of life) in addition Quality- Adjusted Life Years QUALYS) will be calculated.

  4. IMPACT of low back pain - PROMIS-9 [ Time Frame: 0, 2, 6 and 12 months ]
    NIH recommended IMpACT: pain intensity, pain interference and functional status; scored from 8-50 (higher score represents more pain impact)


Other Outcome Measures:
  1. Lumbar Spine Instability Questionnaire: Effect Modifier: [ Time Frame: 0, 2 and 12 months ]
    Measure self reported 'clinical instability'; total score 0-15 (higher scores represent more instability) (Participants will be dichotomized as having instability >=9 or no instability <9)

  2. Effect Modifier: OREBRO LBP screening questionnaire [ Time Frame: 0, 2 and 12 months ]
    Measures attitudes and behavior towards pain; total score 11-192 (higher scores represent worse attitudes and behavior) (Median scores will be used to dichotomize participants into high and low scores)

  3. Effect Modifier: TAMPA scale of kinesiophobia [ Time Frame: 0, 2 and 12 months ]
    Measures fear of movement; total score from 0-52 (higher scores represent worse kinesophobia) (median scores will be used to dichotomize participants into high or low scores)

  4. Effect Modifier: Coping strategies questionnaire [ Time Frame: 0, 2 and 12 months ]
    Measures coping strategies; total score from 0-36 (higher scores represent worse coping) (median scores will be used to dichotomize participants into high or low scores)

  5. Effect Modifier: painDetect Questionnaire [ Time Frame: 0, 2 and 12 months ]
    This questionnaire total score >18 will classify participants into neuropathic or non neuropathic pain(dichotomous outcome)

  6. Effect Modifier: SMART clinical checklist [ Time Frame: 0, 2 and 12 months ]
    The sub-cores of the questionnaire as per SMART et al will be used to used to discriminate between nociceptive, neuropathic and nociplastic pain. (Nominal scale)

  7. Effect Modifier: Pain Pressure Threshold Assessment [ Time Frame: 0, 2 and 12 months ]
    PPT will be assessed at the lumbar spine (point with most pain) and thumbnail (distal point) using an algometer. Difference in PPT between local and distal sites will be included in the analysis. (high scores will represent more nociplastic pain)

  8. Publicly funded health care costs [ Time Frame: 1 year prior to intervention, 12 months follow-up ]
    Health care utilization costs will be extracted from the Ontario Health Funder database and an IC/ES (Institute for Clinical Evaluative Sciences) algorithm will be used to calculate health care utilization dollars per participant.

  9. Patient direct health care costs [ Time Frame: 12 months follow-up ]
    Direct health care costs (e.g. physiotherapy, travel) will be calculated following the completion of a health care utilization questionnaire. Total utilization will be reported as dollars per participants

  10. Societal health care costs [ Time Frame: 12 months follow-up ]
    Indirect health care costs (e.g. work lost productivity) will be calculated following the completion of a health care utilization questionnaire. Total utilization will be reported as dollars per participants



Information from the National Library of Medicine

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

Inclusion Criteria:

  • chronic non-specific LBP (>3 months) with or without leg pain
  • back pain being the primary musculoskeletal complaint of the patient
  • between 18 to 80 years of age,
  • English speaking (to allow response to questionnaires and communication with physiotherapist),
  • moderate or greater pain or disability measured using question 7 and 8 of the SF-36,34
  • moderate or high risk classification on the STarT Back Tool indicating appropriateness of physiotherapy and thus an exercise program.

Exclusion Criteria:

  • nerve root compromise (2 strength, reflex or sensation affected for the same nerve root)
  • suspected or confirmed serious pathology (e.g. infection, fracture, cancer, inflammatory arthritis, cauda equina syndrome)
  • pregnancy
  • scheduled or on the wait list for surgery during trial period
  • cognitive impairment that precludes participant from completing study questionnaires or comply with exercise recommendations (e.g. dementia, Alzheimers)
  • severe neuromuscular condition (e.g. spinal cord injury) that precludes participant from engaging in activity exercise.
  • clinical assessment indicating that the participant is not suitable for active exercises (by a family physician, or using the Physical Activity Readiness Questionnaire).

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): NCT04283409


Contacts
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Contact: Luciana G Macedo, PhD 289-426-0824 macedol@mcmaster.ca
Contact: Julia Schneider, Ba 905-525-9140 ext 23811 schneij8@mcmaster.ca

Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Macquarie University, Australia
Laval University
The University of Queensland
University of Alberta
Investigators
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Principal Investigator: Luciana G Macedo, PhD McMaster University
Publications:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04283409    
Other Study ID Numbers: HiREB#7986
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be requested directly to the principal investigator or may be made available upon publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available following publication of the results.
Access Criteria: Ethics approval will be required for any secondary analysis of data as per HiREB approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms