YOga for Patients with Chronic BACK Pain and Poor PROgnosis
NCT ID: NCT05953155
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-07-27
2027-07-30
Brief Summary
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\- 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire.
* have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale.
Exclusion Criteria
* nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve).
* previos spinal surgery.
* pregnancy or having given birth within the previous 3 months.
* any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases).
* any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year.
* not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise).
* inadequate Portuguese literacy for the study's questionnaires and instructions.
18 Years
60 Years
ALL
No
Sponsors
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Federal University of Minas Gerais
OTHER
Responsible Party
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Rafael Zambelli Pinto
Principal Investigator
Principal Investigators
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Rafael Z Pinto, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
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IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAAE: 57028022.0.0000.5149
Identifier Type: -
Identifier Source: org_study_id
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