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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation-based exercises | Experimental | Home therapeutic exercise intervention scheduled through a software of digital physiotherapy and telerehabilitation |
|
| Standard home-based exercise | Active Comparator | Home therapeutic exercise program scheduled through a dossier and an exercise diary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Disability measured using the Oswestry Disability Index | 8 weeks measurement (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Range of movement (Schober score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo MartÃn-San AgustÃn, PhD | Contact | +34 963 983 853 | rodrigo.martin@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo MartÃn-San AgustÃn, PhD | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Recruiting | Valencia | Select One | 46010 | Spain |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| 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. |
|
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) |
| 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) |
| 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) |
| 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) |
| Muscle thickness (transversus abdominis) | Muscle thickness (transversus abdominis) measured using ultrasonography | 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]) | Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) |
| Medication intake | Medication intake registered using a diary | 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]) | 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]) | 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]) | 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]) | Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) |
| Adherence | Adherence measured using the TRAK application | Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) |
| Adherence | Adherence measured using an exercise diary | Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |