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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043780
• Other study ID #: PI19/334
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Decompression prototype splint for carpal tunnel syndrome
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.
• Standard splint for carpal tunnel syndrome
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.

Locations

Country	Name	City	State
Spain	Elena Estébanez de Miguel	Zaragoza

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Institut Català de la Salut, Salud Aragon, Universitat de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Nerve conduction studies at baseline	The nerve conduction will be assess with electroneurogram.	Baseline
Primary	Nerve conduction studies at 6 weeks	The nerve conduction will be assess with electroneurogram.	6 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Adherence to the treatment	The participants will fill in a calendar indicating the hours of use	6 weeks