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Not yet recruiting NCT06437314

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

No phase Interventional Low Back Pain Exercise Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aquatic program based on the back school.
Who it may be relevant to
Registry conditions: Low Back Pain, Exercise, Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 o

Primary outcome measures

  • Visual Analogue Scale. [Time frame: Through study completion, an average of 2 months.]
  • Roland Morris Disability Questionnaire. [Time frame: Through study completion, an average of 2 months.]
  • Short-Form Health Survey-36. [Time frame: Through study completion, an average of 2 months.]
  • Tampa Scale Of Kinesiophobia. [Time frame: Through study completion, an average of 2 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Beone Sport center — Pontevedra

Identifiers

NCT: NCT06437314 · EE acuático

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗