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

NCT06446596 | Recruiting

• 1 other identifier: Telerehab_Low_back_pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

low back pain; exercise; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Disability

  Disability measured using the Oswestry Disability Index

  8 weeks measurement (post intervention)

Secondary Outcomes (14)

• Disability

  Baseline; 32 weeks measurement (24 weeks post intervention)

• Range of movement (Schober score)

  Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

• Range of movement (Finger floor distance test)

  Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

• Extensor low back muscle strength

  Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

• Muscle thickness (low back extensor muscles)

  Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

Study Arms (2)

Telerehabilitation-based exercises

EXPERIMENTAL

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

Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK

Standard home-based exercise

ACTIVE COMPARATOR

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

Other: Standard home-based exercise

Interventions

Exercise supported by the digital physiotherapy and telerehabilitation software TRAK 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.

Telerehabilitation-based exercises

Standard home-based exercise 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.

Standard home-based exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonspecific subacute or chronic low back pain

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Select One, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rodrigo Martín-San Agustín, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Martín-San Agustín, PhD

CONTACT

+34 963 983 853; rodrigo.martin@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)