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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05953155
Other study ID # CAAE: 57028022.0.0000.5149
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 27, 2023
Est. completion date June 30, 2025

Study information

Verified date July 2023
Source Federal University of Minas Gerais
Contact Rafael Z Pinto, PhD
Phone +55 31 3409 7405
Email rafaelzp@ufmg.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
Brazil IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

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