Non-specific Low Back PainNCT04283409
Which Exercise for Low Back Pain? Predicting Response to Exercise for Patients With Low Back Pain
A study testing Graded activity in people with Non-specific Low Back Pain, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Graded activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain - a Validation Randomized Controlled Trial
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.
Read the detailed description
Background:
Clinical practice guidelines consistently endorse exercise therapy for the treatment of low back pain (LBP). While exercise is more effective than no intervention, the effect size of exercise, like other treatments for LBP, is relatively small. While there are many forms of exercise therapies available (e.g. general exercise, pilates), there is no clear evidence of superiority of one exercise over another. A widely held belief is that the small effect for exercise is due to the heterogeneity of people presenting with LBP and if individual patients could be better matched to the optimal types of exercise, then the effects of treatment would be greater.A recently published study conducted by the study investigators provided preliminary evidence supporting the hypothesis of better outcomes when patients are matched to the appropriate exercise. The study demonstrated that a simple 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to either of the most common exercise approaches for LBP. Participants who had low scores on the LSIQ had better outcomes with graded activity while those with higher scores had better outcomes with motor control exercise. Theoretically, motor control would work best on those that have poor coordination and control of the trunk muscles and graded activity would work best on those with unhelpful beliefs and attitudes towards back pain. Although the results of this study have the potential to transform exercise treatment for LBP, validation and confirmation off the results in a fully powered study using an independent sample is essential before recommending implementation in clinical practice. Validation and impact analysis are crucial steps in the investigation of effect modification models.
Research aims:
The primary aim of this study is to evaluate whether pre-identified baseline characteristics, including the LSIQ, can modify the response to two of the most prominent exercise therapies (graded activity and motor control) for non-specific LBP.
The secondary aims include a cost-effectiveness analysis of a potential stratified care model.
Exploratory aims include the evaluation of potential new effect modifiers that may strengthen the initial prediction model. This include measures of central pain mechanisms to differentiate nociceptive, neuropathic and nociplastic pain.
Methods:
Participants (414) will be recruited by primary care professionals and will be randomized (1:1) to receive either motor control exercises or graded activity. Participants will receive 12 sessions of exercise therapy,delivered by a physiotherapist, over an 8-week period. The primary outcome will be disability at 2 months measured using the Oswestry Disability Index. Secondary outcomes will be pain, function and quality of life measured at 2, 6 and 12 months.
Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitization. The study will follow specific guidelines for the conduction of effect modification studies.
Expected outcomes:
The results of this study will provide the foundation for the implementation of the study results in large scale which would significantly improve the effects of exercise for LBP. Furthermore, it will provide cost-effectiveness information to guide clinical decision making. Implementation of this approach would be simple as both treatments are already widely used and the method to identify subgroups of responders to each approach is straight forward, quick and at no cost.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Graded activity, Motor Control Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded activityOther
Exercise therapy using principles of cognitive behavioral therapy and education
Motor Control ExercisesOther
Exercise therapy using principles of motor control and motor learning and education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Graded activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
disease specific disability questionnaire; total score from 0-100 (higher scores represent worse disability)
Measured: 2 months
Secondary outcomes (4)
Patient Specific Functional Scale
Rate 3 problematic activities; average of the 3 activities generate a total score from 0-10 (lower scores represent worse function)
Measured: 0, 2, 6 and 12 months
Pain Numeric Ranting Scale
Pain over the last week; total score from 0-10 (higher scores represent worse pain)
Measured: 0, 2, 6 and 12 months
EQ-5D-5L
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.
Measured: 0, 2, 6 and 12 months
IMPACT of low back pain - PROMIS-9
NIH recommended IMpACT: pain intensity, pain interference and functional status; scored from 8-50 (higher score represents more pain impact)
Measured: 0, 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start15 Sep 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Macquarie University, Australia, Laval University, The University of Queensland, University of Alberta
- Responsible party
- Principal investigator, Luciana Macedo, McMaster University
- Investigators
- Luciana G Macedo, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283409
- Sponsor's protocol ID
- HiREB#7986
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be requested directly to the principal investigator or may be made available upon publication.
Publications
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.
PubMed 25013000Macedo 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.
PubMed 33472786
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain - a Validation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04283409
- Acronym / sponsor ID
- HiREB#7986
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Macquarie University, Australia, Laval University, The University of Queensland, University of Alberta
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Clinical practice guidelines consistently endorse exercise therapy for the treatment of low back pain (LBP). While exercise is more effective than no intervention, the effect size of exercise, like other treatments for LBP, is relatively small. While there are many forms of exercise therapies available (e.g. general exercise, pilates), there is no clear evidence of superiority of one exercise over another. A widely held belief is that the small effect for exercise is due to the heterogeneity of people presenting with LBP and if individual patients could be better matched to the optimal types of exercise, then the effects of treatment would be greater.A recently published study conducted by the study investigators provided preliminary evidence supporting the hypothesis of better outcomes when patients are matched to the appropriate exercise. The study demonstrated that a simple 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to either of the most common exercise approaches for LBP. Participants who had low scores on the LSIQ had better outcomes with graded activity while those with higher scores had better outcomes with motor control exercise. Theoretically, motor control would work best on those that have poor coordination and control of the trunk muscles and graded activity would work best on those with unhelpful beliefs and attitudes towards back pain. Although the results of this study have the potential to transform exercise treatment for LBP, validation and confirmation off the results in a fully powered study using an independent sample is essential before recommending implementation in clinical practice. Validation and impact analysis are crucial steps in the investigation of effect modification models.
Research aims:
The primary aim of this study is to evaluate whether pre-identified baseline characteristics, including the LSIQ, can modify the response to two of the most prominent exercise therapies (graded activity and motor control) for non-specific LBP.
The secondary aims include a cost-effectiveness analysis of a potential stratified care model.
Exploratory aims include the evaluation of potential new effect modifiers that may strengthen the initial prediction model. This include measures of central pain mechanisms to differentiate nociceptive, neuropathic and nociplastic pain.
Methods:
Participants (414) will be recruited by primary care professionals and will be randomized (1:1) to receive either motor control exercises or graded activity. Participants will receive 12 sessions of exercise therapy,delivered by a physiotherapist, over an 8-week period. The primary outcome will be disability at 2 months measured using the Oswestry Disability Index. Secondary outcomes will be pain, function and quality of life measured at 2, 6 and 12 months.
Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitization. The study will follow specific guidelines for the conduction of effect modification studies.
Expected outcomes:
The results of this study will provide the foundation for the implementation of the study results in large scale which would significantly improve the effects of exercise for LBP. Furthermore, it will provide cost-effectiveness information to guide clinical decision making. Implementation of this approach would be simple as both treatments are already widely used and the method to identify subgroups of responders to each approach is straight forward, quick and at no cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Control Exercise | Experimental | Other: Motor Control ExercisesThe 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. |
| Graded Activity | Experimental | Other: Graded activityThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded activityExercise therapy using principles of cognitive behavioral therapy and education | Other | Graded Activity |
| Motor Control ExercisesExercise therapy using principles of motor control and motor learning and education | Other | Motor Control Exercise |
Primary outcome
Oswestry Disability Index
Time frame: 2 months
disease specific disability questionnaire; total score from 0-100 (higher scores represent worse disability)
4 secondary outcomes
Patient Specific Functional Scale
Time frame: 0, 2, 6 and 12 months
Pain Numeric Ranting Scale
Time frame: 0, 2, 6 and 12 months
EQ-5D-5L
Time frame: 0, 2, 6 and 12 months
IMPACT of low back pain - PROMIS-9
Time frame: 0, 2, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 25013000Macedo 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.
- Derived from this study: PubMed 33472786Macedo 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.
- Individual participant dataSharing planned: Yes. Data may be requested directly to the principal investigator or may be made available upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana G Macedo, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded activity in people with Non-specific Low Back Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283409, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.