YOga for Patients with Chronic BACK Pain and Poor PROgnosis (YOBACK-PRO)

Federal University of Minas Gerais

Status: Enrolling

Conditions: Chronic Low-back Pain; Back Pain; Back Pain Lower Back Chronic; Low Back Pain

Treatments: Other: Yoga; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05953155

CAAE: 57028022.0.0000.5149

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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

• serious spine pathology (e.g. tumors, fractures, and inflammatory diseases).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Control

Other group

Description:

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.

Treatment:

Other: Control

Yoga

Experimental group

Description:

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.

Treatment:

Other: Yoga