Telerehabilitation-based Exercises vs Standard Home-based Exercise in Low Back Pain

NCT ID: NCT06446596

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-12-31

Brief Summary

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The objective of the study is to compare the effect of a telerehabilitation-based exercise program, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.

Detailed Description

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The objective of the study is to compare the effect of a telerehabilitation-based exercise program, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.

This randomized controlled trial has a parallel design, with two groups. Both groups will complete an 8-week home exercise program that includes flexibility and strength exercises. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. In the case of the experimental group, the program will be carried out with the support of the TRAK computer tool (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows investigators/clinicians to keep a record of the sessions. In the case of the control group, the program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted. In both groups, as an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively.

The exercise program includes flexibility and strength exercises, each made up of three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telerehabilitation-based exercises

Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation

Group Type EXPERIMENTAL

Exercise supported by the digital physiotherapy and telerehabilitation software TRAK

Intervention Type OTHER

8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software a digital physiotherapy and telerehabilitation. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows you to keep a record of the sessions. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.

Standard home-based exercise

Home therapeutic exercise program scheduled through a dossier and an exercise diary

Group Type ACTIVE_COMPARATOR

Standard home-based exercise

Intervention Type OTHER

8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted.. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.

Interventions

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Exercise supported by the digital physiotherapy and telerehabilitation software TRAK

8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software a digital physiotherapy and telerehabilitation. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows you to keep a record of the sessions. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.

Intervention Type OTHER

Standard home-based exercise

8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted.. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Nonspecific subacute or chronic low back pain

Exclusion Criteria

* Neuropathic pain
* Pain below the knees
* Pain in legs with tingling, sensation of current or sensory alterations
* Positive neurological tests. Lack of strength, sensitivity or altered reflexes
* Canal stenosis
* Nociplastic pain (fibromyalgia, generalized pain, emotional lability, affective and cognitive implications)
* Previous lumbar surgery
* Specific pathology (rheumatic, spondylolisthesis, oncological, fractures...)
* Pregnancy
* Performing medium-high intensity exercise of more than 100 minutes a week
* Pathology that prevents exercise (decompensated cardiac pathology, decompensated respiratory pathology, significant mobility difficulties...)
* Lack of digital skills
* Visual problems that prevent exercise with the phone screen
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Martín-San-Agustin

Assistant Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Martín-San Agustín, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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University of Valencia

Valencia, Select One, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rodrigo Martín-San Agustín, PhD

Role: CONTACT

+34 963 983 853

Facility Contacts

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Rodrigo Martin San Agustín

Role: primary

963983855

Other Identifiers

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Telerehab_Low_back_pain

Identifier Type: -

Identifier Source: org_study_id

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