Clinical trial NCT06437314: Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain
Official title: Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Exercise
Healthy
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Visual Analogue Scale.
timeFrame: Through study completion, an average of 2 months.
measure: Roland Morris Disability Questionnaire.
timeFrame: Through study completion, an average of 2 months.
measure: Short-Form Health Survey-36.
timeFrame: Through study completion, an average of 2 months.
measure: Tampa Scale Of Kinesiophobia.
timeFrame: Through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Beone Sport center
Study officials:
References: