YOga for Patients with Chronic BACK Pain and Poor PROgnosis

Last updated: March 13, 2025
Sponsor: Federal University of Minas Gerais
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Yoga

Control

Clinical Study ID

NCT05953155
CAAE: 57028022.0.0000.5149
  • Ages 18-60
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • report chronic nonspecific LBP, defined as pain and discomfort localized below thecostal margin and above the inferior gluteal folds, with or without leg pain and ofat 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 painrating scale.

Exclusion

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, reflexchange, 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., seriouscardiovascular, kidney or neurological diseases).

  • any other musculoskeletal condition that may affect activity and movementparticipation 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

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Yoga
Phase:
Study Start date:
July 27, 2023
Estimated Completion Date:
July 30, 2027

Connect with a study center

  • IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais

    Belo Horizonte, Minas Gerais 30130-110
    Brazil

    Active - Recruiting

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