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

NCT04283409 | Completed

• 1 other identifier: HiREB#7986
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  disease specific disability questionnaire; total score from 0-100 (higher scores represent worse disability)

  2 months

Secondary Outcomes (4)

• Patient Specific Functional Scale

  0, 2, 6 and 12 months

• Pain Numeric Ranting Scale

  0, 2, 6 and 12 months

• EQ-5D-5L

  0, 2, 6 and 12 months

• IMPACT of low back pain - PROMIS-9

  0, 2, 6 and 12 months

Other Outcomes (10)

• Lumbar Spine Instability Questionnaire: Effect Modifier:

  0, 2 and 12 months

• Effect Modifier: OREBRO LBP screening questionnaire

  0, 2 and 12 months

• Effect Modifier: TAMPA scale of kinesiophobia

  0, 2 and 12 months

Study Arms (2)

Motor Control Exercise

EXPERIMENTAL

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

Graded Activity

EXPERIMENTAL

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

Interventions

Graded activity OTHER

Exercise therapy using principles of cognitive behavioral therapy and education

Graded Activity

Motor Control Exercises OTHER

Exercise therapy using principles of motor control and motor learning and education

Motor Control Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Macquarie University, Australia: collaborator
• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laval University: collaborator
• The University of Queensland: collaborator
• University of Alberta: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (2)

• Macedo LG, Maher CG, Hancock MJ, Kamper SJ, McAuley JH, Stanton TR, Stafford R, Hodges PW. Predicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial. Phys Ther. 2014 Nov;94(11):1543-54. doi: 10.2522/ptj.20140014. Epub 2014 Jul 10.

  PMID: 25013000 BACKGROUND

• Macedo LG, Hodges PW, Bostick G, Hancock M, Laberge M, Hanna S, Spadoni G, Gross A, Schneider J. Which Exercise for Low Back Pain? (WELBack) trial predicting response to exercise treatments for patients with low back pain: a validation randomised controlled trial protocol. BMJ Open. 2021 Jan 20;11(1):e042792. doi: 10.1136/bmjopen-2020-042792.

  PMID: 33472786 DERIVED

Study Officials

• Luciana G Macedo, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the exercise nature of the study it is not possible to blind therapists or patients, however; assessors will remain blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 25, 2020
• Study Start: September 15, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CA (1)