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

July 28, 2023 updated by: Rafael Zambelli Pinto, Federal University of Minas Gerais

Effectiveness of YOga in Patients With Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rafael Z Pinto, PhD
  • Phone Number: +55 31 3409 7405
  • Email: rafaelzp@ufmg.br

Study Contact Backup

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-110
        • Recruiting
        • IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Post-intervention (i.e. 3 months after randomisation)
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Post-intervention (i.e. 3 months after randomisation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 6 months after randomisation
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
6 months after randomisation
Pain intensity
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Quality of life
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Depressive symptoms
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Pain self-efficacy
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Rafael Z Pinto, PhD, Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 57028022.0.0000.5149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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