Comparison of Different Treatment Approaches in Carpal Tunnel Syndrome

May 15, 2024 updated by: Banu BAYAR, Muğla Sıtkı Koçman University

Comparison of the Efficacy of Different Treatment Approaches in Carpal Tunnel Syndrome: Randomized Controlled Double-Blind Study

The effectiveness of various external applications (strapping and splinting) on grip strength, pain intensity, symptom level, and functional status in carpal tunnel syndrome (CTS) has been compared in this study. Comparative testing was conducted with exercise and mobilization applications (carpal bone mobilization, yoga, tendon and nerve gliding exercises, neurodynamic mobilization, instrument-assisted soft tissue massage, and standard soft tissue massage) in control groups, placebo groups, and groups undergoing other non-surgical treatments (orthotic application, steroid injections, and other physical agents). Criticisms regarding these studies include bias, lack of blinding, and small intergroup differences. In the literature, evidence supporting the beneficial effects of splinting and strapping applications on CTS is reported to be of low quality, emphasizing the need for higher-quality studies. In light of the information obtained, this study aims to compare the effects of different external applications (strapping and splinting) on grip strength, pain intensity, symptom level, and functional status in CTS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The inclusion of 40 volunteers is planned for the study. Participants will be divided into four groups, namely control, splint, rigid strapping, and kinesiotape, with the intention of having 10 participants in each group using the closed envelope method.

In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.

In the Splint (SP) group, in addition to the 10-session conventional physiotherapy program, individuals will be instructed to use the splint prescribed by the physician for 2 weeks.

In the Rigid Strapping (RB) group, along with the 10-session conventional physiotherapy program, a rigid strapping application will be performed by an experienced researcher at the end of each physiotherapy session, five days a week.

In the Kinesiotape (KT) group, in addition to the 10-session conventional physiotherapy program, kinesiotape application will be carried out by a certified researcher. To ensure homogeneity, individuals in both strapping groups will be asked to remove the tape before coming to treatment and reapply it at the end of the session. All participants included in the study will be evaluated twice, before and after treatment.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey
      • Muğla, Turkey, 48000
        • Muğla Sıtkı Koçman University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be volunteered
  • To be in the age range of 18-65
  • To be diagnosed with mild to moderate carpal tunnel syndrome (CTS) through median nerve conduction velocity studies
  • To have experienced paresthesia, pain, and vasomotor symptoms in the area associated with the N. medianus for more than six weeks, as determined by studies on median nerve conduction.
  • To test positive in Phalen, Tinel, or carpal compression tests
  • To have been recommended splint therapy for CTS

Exclusion Criteria:

  • Having a distal motor latency of the median nerve of less than 4.2 milliseconds and/or a distal sensory latency of less than 3.2 milliseconds as a result of electrodiagnostic studies on nerve conduction velocity
  • History of malignant tumor
  • Use of a pacemaker
  • Presence of severe electrodiagnostic findings (fibrotic changes in the median nerve)
  • Another inflammatory condition (rheumatoid arthritis, tendinitis, etc.)
  • Osteoarthritis in the hand/wrist
  • Any musculoskeletal conditions affecting the hand, elbow, or wrist
  • Yhyroid dysfunction
  • Diagnosis of chronic kidney failure and undergoing treatment for it
  • History of carpal tunnel surgery, upper extremity, and neck surgery and trauma
  • Diagnosis of carpal tunnel syndrome associated with pregnancy or diabetes
  • Having received any treatment for carpal tunnel syndrome (splint therapy, physical agents, exercise, local corticosteroid injection) up to 3 months before the tests
  • Hypersensitivity (allergy to Kinesiotape or rigid strapping)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.
Other: Splint and taping methods

In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.

Splint group: CG + Splint Rigid taping group: CG+ Rigid taping Kinesiotape: CG+ kinesiotape
Experimental: Splint
In the Splint (SP) group, in addition to the 10-session conventional physiotherapy program, individuals will be instructed to use the splint prescribed by the physician for 2 weeks.
Other: Splint and taping methods

In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.

Splint group: CG + Splint Rigid taping group: CG+ Rigid taping Kinesiotape: CG+ kinesiotape
Experimental: Rigid taping
In the Rigid taping (RB) group, along with the 10-session conventional physiotherapy program, a rigid strapping application will be performed by an experienced researcher at the end of each physiotherapy session, five days a week.
Other: Splint and taping methods

In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.

Splint group: CG + Splint Rigid taping group: CG+ Rigid taping Kinesiotape: CG+ kinesiotape
Experimental: Kinesiotape
In the Kinesiotape (KT) group, in addition to the 10-session conventional physiotherapy program, kinesiotape application will be carried out by a certified researcher. To ensure homogeneity, individuals in both strapping groups will be asked to remove the tape before coming to treatment and reapply it at the end of the session.
Other: Splint and taping methods

In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.

Splint group: CG + Splint Rigid taping group: CG+ Rigid taping Kinesiotape: CG+ kinesiotape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visuai Analog Scale (VAS)
Time Frame: Baseline- after two weeks
Pain
Baseline- after two weeks
Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: Baseline- after two weeks
Symptom and Function
Baseline- after two weeks
Handgrip Dynamometer
Time Frame: Baseline- after two weeks
Grip
Baseline- after two weeks

Collaborators and Investigators

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

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Özge ipek Dongaz, Muğla Sıtkı Koçman University

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)

January 2, 2024

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

April 2, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/XIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not a study that requires sharing of personal data. Participants' data regarding the study will be given anonymously during publication.

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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