YOga for Patients With Chronic BACK Pain and Poor PROgnosis

Not Applicable

Recruiting

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

• Registration Number: NCT05953155
• Lead Sponsor: Federal University of Minas Gerais

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-19
• Study Start: 2023-07-27
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability	Post-intervention (i.e. 3 months after randomisation)	Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)

Secondary Outcome Measures

Name	Time	Method
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)
Disability	6 months after randomisation	Roland Morris Disability Questionnaire (RMDQ) (0-24 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)

Trial Locations

Locations (1)

IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil