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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Rafael Z Pinto, PhD
rafaelzp@ufmg.br
+55 31 3409 7405
Backup
Simone M Nunes, MSc
simacnunes@gmail.com
+55 31 32473137
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 110
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Federal University of Minas Gerais

This content was sourced from clinicaltrials.gov