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

Effect of the Implementation of Telerehabilitation-based Exercises Compared to the Standard Use of Exercise Dossier and Intervention Diary in a Home Therapeutic Exercise Intervention in Patients With Low Back Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Standard home-based exercise; Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo Martín-San Agustín, PhD; Phone Number: +34 963 983 853; Email: rodrigo.martin@uv.es

Study Locations

• Spain
  • Select One
    • Valencia, Select One, Spain, 46010
      • Recruiting
      • University of Valencia
      • Contact: Rodrigo Martin San Agustín; Phone Number: 963983855; Email: rodrigo.martin@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard home-based exercise; Home therapeutic exercise program scheduled through a dossier and an exercise diary	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.
Experimental: Telerehabilitation-based exercises; Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Disability measured using the Oswestry Disability Index	8 weeks measurement (post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle thickness (low back extensor muscles)	Muscle thickness (low back extensor muscles) measured using ultrasonography	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Muscle thickness (transversus abdominis)	Muscle thickness (transversus abdominis) measured using ultrasonography	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Medication intake	Medication intake registered using a diary	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Disability	Disability measured using the Oswestry Disability Index (range score from 0 [less disability] to 100 [more disability])	Baseline; 32 weeks measurement (24 weeks post intervention)
Range of movement (Schober score)	Range of movement measured using the modified Schober score (a higher score is an indicator of better range of movement)	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Range of movement (Finger floor distance test)	Range of movement measured using the Finger floor distance test (a lower distance is an indicator of better range of movement)	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Extensor low back muscle strength	Extensor low back muscle strength measured using the Biering-Sorensen test (a higher score is an indicator of better strength)	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Low Back Pain	Mean pain during last week measured with a numerical pain rating scale (range score from 0 [no pain] -10 [worst pain])	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Kinesiphobia	Kinesiofobia measured using the Tampa Scale of Kinesiofobia (range score from 17 [lower levels of kinesiophobia]-68 [higher levels of kinesiophobia])	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Depression	Depression measured using the Beck Depression Inventory (range score from 0 [better status] to 63 [severe depression])	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Fear Avoidance Beliefs	Fear Avoidance Beliefs measured using the Fear Avoidance Belief Questionnaire (range score from 0 [Lower levels of fear-avoidance beliefs] to 96 [higher levels of fear-avoidace beliefs])	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Fear Avoidance Components	Fear Avoidance Beliefs measured using the Fear Avoidance Components Scale (range score from 0 [Lower levels of fear-avoidance components] to 100 [higher levels of fear-avoidace components])	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence	Adherence measured using the TRAK application	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence	Adherence measured using an exercise diary	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Rodrigo Martín-San Agustín, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; low back pain; telerehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Low Back Pain; Motor Activity
• Other Study ID Numbers: Telerehab_Low_back_pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No