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

Non-specific Low Back Pain Clinical Trial

Official title:

Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain - a Validation Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283409
• Other study ID #: HiREB#7986
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: July 30, 2025

Study information

• Verified date: June 2023
• Source: McMaster University
• Contact: Luciana G Macedo, PhD
• Phone: 289-426-0824
• Email: macedol[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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, neuropatic 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: July 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Low Back Pain

Intervention

Other:
• Graded activity
Exercise therapy using principles of cognitive behavioral therapy and education
• Motor Control Exercises
Exercise therapy using principles of motor control and motor learning and education

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Laval University, Macquarie University, Australia, The University of Queensland, University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lumbar Spine Instability Questionnaire: Effect Modifier:	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)	0, 2 and 12 months
Other	Effect Modifier: OREBRO LBP screening questionnaire	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)	0, 2 and 12 months
Other	Effect Modifier: TAMPA scale of kinesiophobia	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)	0, 2 and 12 months
Other	Effect Modifier: Coping strategies questionnaire	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)	0, 2 and 12 months
Other	Effect Modifier: painDetect Questionnaire	This questionnaire total score >18 will classify participants into neuropathic or non neuropathic pain(dichotomous outcome)	0, 2 and 12 months
Other	Effect Modifier: SMART clinical checklist	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)	0, 2 and 12 months
Other	Effect Modifier: Pain Pressure Threshold Assessment	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)	0, 2 and 12 months
Other	Publicly funded health care costs	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.	1 year prior to intervention, 12 months follow-up
Other	Patient direct health care costs	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	12 months follow-up
Other	Societal health care costs	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	12 months follow-up
Primary	Oswestry Disability Index	disease specific disability questionnaire; total score from 0-100 (higher scores represent worse disability)	2 months
Secondary	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)	0, 2, 6 and 12 months
Secondary	Pain Numeric Ranting Scale	Pain over the last week; total score from 0-10 (higher scores represent worse pain)	0, 2, 6 and 12 months
Secondary	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.	0, 2, 6 and 12 months
Secondary	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)	0, 2, 6 and 12 months