Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome

Study Overview
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Brief Summary
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A multicentric randomized controlled trial has been designed to study the effects of a decompression prototype splint on symptoms, functional capacity and nerve conduction studies in patients with carpal tunnel syndrome.

Detailed Description
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A decompression prototype splint was designed to simulate an manual mobilization that is able to increase the CSA of the carpal tunnel and the median nerve in cadavers. These changes are important because they may relate to the decrease in CTS symptoms. Patients with mild or moderate carpal tunnel syndrome will be selected for the trial. They will be randomized in 2 groups. One group will wear an standard splint for carpal tunnel syndrome and the other the decompression prototype splint.

Official Title
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Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome: a Multicentric Randomized Controlled Trial

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: Decompression prototype splint for carpal tunnel syndrome
* Device: Standard splint for carpal tunnel syndrome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be medically diagnosed with carpal tunnel syndrome after electrophysiological tests and present mild to moderate involvement. This test is performed according to the standards established by the American Academy of Physical Medicine and Rehabilitation Ability to understand and communicate their symptoms and to complete the questionnaires. Exclusion Criteria: Previous surgery in the carpal tunnel in the same limb Other pathologies that may be associated with carpal tunnel syndrome: traumas, pathologies or disorders of the upper limb or cervical spine (cervical radiculopathy, cervical sprain, etc.) or prior cervical surgery Concurrent comorbidities that may be the cause and interfere with the treatment of the carpal tunnel syndrome: diabetes mellitus, hypothyroidism, rheumatoid arthritis, fibromyalgia, reflex sympathetic dysfunction, obesity, renal disease, alcoholism, significant vitamin deficiency and associated viral or bacterial processes Pregnancy Oral drugs, physiotherapy treatment , treatment with splints or infiltrations for carpal tunnel syndrome prior or during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decompression prototype splint<br>The patients of this group will wear the decompression prototype splint. | Device: Decompression prototype splint for carpal tunnel syndrome<br>* This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.<br>|
| Active Comparator: standard splint<br>The patients of this group will wear a standard splint. | Device: Standard splint for carpal tunnel syndrome<br>* This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of symptoms at baseline | Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure. | Baseline | 
| Intensity of the symptoms at 6 weeks | Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure. | 6 weeks | 
| Intensity of the symptoms at 4 months | Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure. | 4 months | 
| Nerve conduction studies at baseline | The nerve conduction will be assess with electroneurogram. | Baseline | 
| Nerve conduction studies at 6 weeks | The nerve conduction will be assess with electroneurogram. | 6 weeks | 
| Self-reported symptom severity and functional status at baseline | This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. | Baseline | 
| Self-reported symptom severity and functional status at 6 weeks | This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. | 6 weeks | 
| Self-reported symptom severity and functional status at 4 months | This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. | 4 months | 
| Global Perceived Effect at 6 weeks | Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPE is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: Compared with the beginning of the episode, how do you describe your wrist/hand today?. Positive scores represent better recovery and negative scores indicate a worsening of symptoms. | 6 weeks | 
| Global Perceived Effect at 4 months | Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPES is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: Compared with the beginning of the episode, how do you describe your wrist/hand today?. Positive scores represent better recovery and negative scores indicate a worsening of symptoms. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the treatment | The participants will fill in a calendar indicating the hours of use | 6 weeks |