Comparison of Different Treatment Approaches in Carpal Tunnel Syndrome

NCT ID: NCT06238440

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-04-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome Splints Rigid Taping Kinesiotape

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective. A randomized controlled double-blind study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type OTHER

Splint and taping methods

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Splint and taping methods

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Splint and taping methods

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Splint and taping methods

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Banu BAYAR

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özge ipek Dongaz

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

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Muğla Sıtkı Koçman University

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2/XIV

Identifier Type: -

Identifier Source: org_study_id

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