Clinical trial NCT06446596: Telerehabilitation-based Exercises Vs Standard Home-based Exercise in Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
exercise
telerehabilitation
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability
timeFrame: 8 weeks measurement (post intervention)
Secondary outcomes:
measure: Disability
timeFrame: Baseline; 32 weeks measurement (24 weeks post intervention)
measure: Range of movement (Schober score)
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Range of movement (Finger floor distance test)
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Extensor low back muscle strength
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Muscle thickness (low back extensor muscles)
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Muscle thickness (transversus abdominis)
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Low Back Pain
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Medication intake
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Kinesiphobia
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Depression
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Fear Avoidance Beliefs
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Fear Avoidance Components
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Adherence
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Adherence
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Rodrigo Martín-San Agustín, PhD
role: PRINCIPAL_INVESTIGATOR
References: