Low Back PainNCT06446596
Telerehabilitation-based Exercises vs Standard Home-based Exercise in Low Back Pain
A study testing Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise in people with Low Back Pain, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonspecific subacute or chronic low back pain
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, Select One, 46010
Rodrigo Martin San Agustín, 963983855, rodrigo.martin@uv.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK, Standard home-based exercise
- Keywords
- low back pain, exercise, telerehabilitation
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise supported by the digital physiotherapy and telerehabilitation software TRAKOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation-based exercises | Experimental | Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation Receives: 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 Receives: Other: Standard home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability measured using the Oswestry Disability Index
Measured: 8 weeks measurement (post intervention)
Secondary outcomes (14)
Disability
Disability measured using the Oswestry Disability Index (range score from 0 [less disability] to 100 [more disability])
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Muscle thickness (low back extensor muscles)
Muscle thickness (low back extensor muscles) measured using ultrasonography
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Muscle thickness (transversus abdominis)
Muscle thickness (transversus abdominis) measured using ultrasonography
Measured: 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])
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Medication intake
Medication intake registered using a diary
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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])
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Adherence measured using the TRAK application
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Adherence measured using an exercise diary
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start4 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
- Investigators
- Rodrigo Martín-San Agustín, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446596
- Sponsor's protocol ID
- Telerehab_Low_back_pain
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06446596
- Acronym / sponsor ID
- Telerehab_Low_back_pain
- Conditions
- Low Back Pain
- Keywords
- low back pain, exercise, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation-based exercises | Experimental | Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAKHome therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation |
| Standard home-based exercise | Active comparator | Other: Standard home-based exerciseHome therapeutic exercise program scheduled through a dossier and an exercise diary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nonspecific subacute or chronic low back pain
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise supported by the digital physiotherapy and telerehabilitation software TRAK8 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. | Other | Telerehabilitation-based exercises |
| Standard home-based exercise8 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. | Other | Standard home-based exercise |
Primary outcome
Disability
Time frame: 8 weeks measurement (post intervention)
Disability measured using the Oswestry Disability Index
14 secondary outcomes
Disability
Time frame: Baseline; 32 weeks measurement (24 weeks post intervention)
Range of movement (Schober score)
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Range of movement (Finger floor distance test)
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Extensor low back muscle strength
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Muscle thickness (low back extensor muscles)
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Muscle thickness (transversus abdominis)
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Low Back Pain
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Medication intake
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Kinesiphobia
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Depression
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Fear Avoidance Beliefs
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Fear Avoidance Components
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Martín-San Agustín, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise in people with Low Back Pain, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Martín-San Agustín, PhD (+34 963 983 853, rodrigo.martin@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: 8 weeks measurement (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.