TRAK vs Standard Home-based Exercise in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effect of the Implementation of the TRAK Application Compared to the Standard Use of Exercise Dossier and Intervention Diary in a Home Therapeutic Exercise Intervention in Patients With Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446596
• Other study ID #: TRAK_Low_back_pain
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: University of Valencia
• Contact: Rodrigo Martín-San Agustín, PhD
• Phone: +34 963 983 853
• Email: rodrigo.martin[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK, 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.

Description:

The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK, 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 of digital physiotherapy and telerehabilitation TRAK. 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Disability measured using the Oswestry Disability Index	8 weeks measurement (post intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Muscle thickness (transversus abdominis)	Muscle thickness (transversus abdominis) measured using ultrasonography	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Secondary	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)
Secondary	Medication intake	Medication intake registered using a diary	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Adherence	Adherence measured using the TRAK application	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Secondary	Adherence	Adherence measured using an exercise diary	Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)