Clinical Trial

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

Withdrawn
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Why the trial stopped
The study was not initiated following an investigator decision not to proceed; no participants were enrolled.
Summary
A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.
Protocol Amendment History 3 changes
critical Withdrawn before enrolling 2026-08-15
critical Trial withdrawn: The study was not initiated following an investigator decision not to proceed; no participants were enrolled. 2026-08-15
notable Enrollment reduced: 65 -> 0 participants 2026-08-15
Trial Details
NCT Number NCT06437314
Lead Sponsor University of Vigo
Conditions Low Back Pain, Exercise, Healthy
Start Date 2025-04-10
Primary Completion 2025-07-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14