YOBACK-PRO: YOga for Patients With Chronic BACK Pain and Poor PROgnosis
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is:
- In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone?
A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control The control group will be invited to attend 3 educational classes. In these sessions, participants will receive evidence-based information about self-management strategies and pain education. |
Other: Control
Each educational class will last for 1 hour and consists of evidence-based information about low back pain, including, for example, self-management strategies, pain education, reassurance and common misconceptions about back pain.
|
| Experimental: Yoga In addition to the invitation to attend the same 3 educational classes on evidence-based information about self-management strategies and pain education, the experimental group will participate in a 12-week, twice-weekly group-based yoga program. |
Other: Yoga
Participants in the intervention group will receive, in addition to the educational classes, a course of yoga program led by certified yoga instructors. The program consists of a 60-min group session with up to 10 participants, delivered twice a week for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Disability [Post-intervention (i.e. 3 months after randomisation)]
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Secondary Outcome Measures
- Disability [6 months after randomisation]
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
- Pain intensity [Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
- Quality of life [Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)
- Depressive symptoms [Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)
- Pain self-efficacy [Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Eligibility Criteria
Criteria
Inclusion Criteria:
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report chronic nonspecific LBP, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration.
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score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire.
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have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale.
Exclusion Criteria:
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serious spine pathology (e.g. tumors, fractures, and inflammatory diseases).
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nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve).
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previos spinal surgery.
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pregnancy or having given birth within the previous 3 months.
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any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases).
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any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year.
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not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise).
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inadequate Portuguese literacy for the study's questionnaires and instructions.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Federal University of Minas Gerais
Investigators
- Principal Investigator: Rafael Z Pinto, PhD, Federal University of Minas Gerais
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAAE: 57028022.0.0000.5149