Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial
| Registry | NCT06437314 |
|---|---|
| Status | Withdrawn - The study was not initiated following an investigator decision not to proceed; no participants were enrolled. |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: single, treatment |
| Sponsor | University of Vigo (Other) |
| Conditions | Low Back Pain, Exercise, Healthy |
| Interventions | Aquatic program based on the back school (Behavioral) |
| Dates | start 2025-04-10 (estimated), primary completion 2025-07-30 (estimated), completion 2025-09-30 (estimated), first posted 2024-05-31, last updated 2026-08-14 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Low Back Pain All trials for Exercise All trials of Aquatic program based on the back school
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Aquatic program based on the back school | Experimental | Behavioral: Aquatic program based on the back school | Participants will undertake a back school-based program. 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 center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain). |
| Control | No intervention | They will continue with their usual lifestyle. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 18-65 years of age. * With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS). Exclusion Criteria: * History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance. * Missing more than two Back School sessions. * Not being able to attend the measurement sessions.
| Facility | City | Country | Status |
|---|---|---|---|
| Beone Sport center | Pontevedra | Spain |