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| Name | Class |
|---|---|
| Salud Aragon | UNKNOWN |
| Universitat de Catalunya | UNKNOWN |
| Institut Català de la Salut | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompression prototype splint | Experimental | The patients of this group will wear the decompression prototype splint. |
|
| standard splint | Active Comparator | The patients of this group will wear a standard splint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompression prototype splint for carpal tunnel syndrome | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the treatment | The participants will fill in a calendar indicating the hours of use | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Estébanez-de-Miguel, PhD | Universidad de Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elena Estébanez de Miguel | Zaragoza | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19797585 | Background | Keith MW, Masear V, Chung KC, Maupin K, Andary M, Amadio PC, Watters WC 3rd, Goldberg MJ, Haralson RH 3rd, Turkelson CM, Wies JL, McGowan R. American Academy of Orthopaedic Surgeons Clinical Practice Guideline on diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2009 Oct;91(10):2478-9. doi: 10.2106/JBJS.I.00643. No abstract available. | |
| 12169318 |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Standard splint for carpal tunnel syndrome | Device | 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. |
|
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 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |