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

November 3, 2020 updated by: Elena Estebanez de Miguel, Universidad de Zaragoza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Elena Estebanez de Miguel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decompression prototype splint
The patients of this group will wear the decompression prototype splint.
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.
Active Comparator: standard splint
The patients of this group will wear a standard splint.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of symptoms at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
The nerve conduction will be assess with electroneurogram.
Baseline
Nerve conduction studies at 6 weeks
Time Frame: 6 weeks
The nerve conduction will be assess with electroneurogram.
6 weeks
Self-reported symptom severity and functional status at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 weeks
The participants will fill in a calendar indicating the hours of use
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Collaborators

Institut Català de la Salut
Salud Aragon
Universitat de Catalunya

Investigators

  • Principal Investigator: Elena Estébanez-de-Miguel, PhD, Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI19/334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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