Telerehabilitation-based Exercises Vs Standard Home-based Exercise in Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Standard home-based exerciseOther: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
- Registration Number
- NCT06446596
- Lead Sponsor
- University of Valencia
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Nonspecific subacute or chronic low back pain
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard home-based exercise Standard home-based exercise Home therapeutic exercise program scheduled through a dossier and an exercise diary Exercise supported by the digital physiotherapy and telerehabilitation software TRAK Exercise supported by the digital physiotherapy and telerehabilitation software TRAK Home therapeutic exercise intervention scheduled through the software of digital physiotherapy and telerehabilitation TRAK
- Primary Outcome Measures
Name Time Method Disability 8 weeks measurement (post intervention) Disability measured using the Oswestry Disability Index
- Secondary Outcome Measures
Name Time Method Range of movement (Schober score) 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)
Disability Baseline; 32 weeks measurement (24 weeks post intervention) Disability measured using the Oswestry Disability Index (range score from 0 \[less disability\] to 100 \[more disability\])
Extensor low back muscle strength 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)
Muscle thickness (low back extensor muscles) Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) Muscle thickness (low back extensor muscles) measured using ultrasonography
Low Back Pain 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 \[worst pain\])
Medication intake Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) Medication intake registered using a diary
Kinesiphobia 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 \[higher levels of kinesiophobia\])
Depression 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 \[severe depression\])
Range of movement (Finger floor distance test) 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)
Fear Avoidance Beliefs 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 \[higher levels of fear-avoidace beliefs\])
Fear Avoidance Components 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 \[higher levels of fear-avoidace components\])
Muscle thickness (transversus abdominis) Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) Muscle thickness (transversus abdominis) measured using ultrasonography
Adherence Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) Adherence measured using an exercise diary