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NCT Number: NCT06446596

Telerehabilitation-based Exercises vs Standard Home-based Exercise in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, Select One, 46010, Spain

Location status: Recruiting

Location contact

Rodrigo Martin San Agustín

CONTACT

[email protected]

963983855

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Disability

    Time frame: 8 weeks measurement (post intervention)

    Disability measured using the Oswestry Disability Index

Secondary outcomes

  1. Disability

    Time frame: Baseline; 32 weeks measurement (24 weeks post intervention)

    Disability measured using the Oswestry Disability Index (range score from 0 [less disability] to 100 [more disability])

  2. Range of movement (Schober score)

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Range of movement measured using the modified Schober score (a higher score is an indicator of better range of movement)

  3. Range of movement (Finger floor distance test)

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Range of movement measured using the Finger floor distance test (a lower distance is an indicator of better range of movement)

  4. Extensor low back muscle strength

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Extensor low back muscle strength measured using the Biering-Sorensen test (a higher score is an indicator of better strength)

  5. Muscle thickness (low back extensor muscles)

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Muscle thickness (low back extensor muscles) measured using ultrasonography

  6. Muscle thickness (transversus abdominis)

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Muscle thickness (transversus abdominis) measured using ultrasonography

  7. Low Back Pain

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Mean pain during last week measured with a numerical pain rating scale (range score from 0 [no pain] -10 [worst pain])

  8. Medication intake

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Medication intake registered using a diary

  9. Kinesiphobia

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Kinesiofobia measured using the Tampa Scale of Kinesiofobia (range score from 17 [lower levels of kinesiophobia]-68 [higher levels of kinesiophobia])

  10. Depression

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Depression measured using the Beck Depression Inventory (range score from 0 [better status] to 63 [severe depression])

  11. Fear Avoidance Beliefs

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    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])

  12. Fear Avoidance Components

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    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])

  13. Adherence

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Adherence measured using the TRAK application

  14. Adherence

    Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)

    Adherence measured using an exercise diary

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Martín-San Agustín, PhD

CONTACT

[email protected]

+34 963 983 853

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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