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NCT Number: NCT06437314

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

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Exercise Healthy Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beone Sport center

Pontevedra, 36003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquatic program based on the back school

Behavioral

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).

Primary outcomes

  1. Visual Analogue Scale.

    Time frame: Through study completion, an average of 2 months.

    The visual analogue scale is a widely used tool to measure pain. The patient is asked to indicate the intensity of the pain they perceive (most commonly) along a horizontal line from 0 millimetres (minimum value) to 100 millimetres (maximum value), and this score is then measured from the left edge, the higher the value in millimetres the more pain.

  2. Roland Morris Disability Questionnaire.

    Time frame: Through study completion, an average of 2 months.

    The Roland Morris Disability Questionnaire Scoring is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total Roland Morris Disability Questionnaire score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.

  3. Short-Form Health Survey-36.

    Time frame: Through study completion, an average of 2 months.

    Short-Form Health Survey was used to measure quality of life.The Short-Form Health Survey-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status).

  4. Tampa Scale Of Kinesiophobia.

    Time frame: Through study completion, an average of 2 months.

    This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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