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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04283409
Other study ID # HiREB#7986
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
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