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WithdrawnNCT06437314Updated Aug 14, 2026

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

An interventional study of Aquatic program based on the back school in Low Back Pain, Exercise and Healthy, sponsored by University of Vigo. Withdrawn at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by University of Vigo · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study was not initiated following an investigator decision not to proceed; no participants were enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Exercise
  • Healthy
03

In context

Low Back Pain

2,820 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

Browse Low Back Pain studies →

Lead sponsor

University of Vigo is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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).

    Behavioral: Aquatic program based on the back school

  • No intervention
    Control

    They will continue with their usual lifestyle.

Interventions

  • BehavioralAquatic 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).

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale.

    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.

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

  2. Roland Morris Disability Questionnaire.

    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.

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

  3. Short-Form Health Survey-36.

    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).

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

  4. Tampa Scale Of Kinesiophobia.

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

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

07

Study locations

1 site
  • Beone Sport center
    Pontevedra, 36003, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06437314
Lead sponsor
University of Vigo
Responsible party
Pablo Hernandez-Lucas (Associate professor in health sciences, University of Vigo) — Principal investigator
First posted
May 31, 2024
Start date
Apr 10, 2025 (estimated)
Primary completion
Jul 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Aug 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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