Comparison of Different Treatment Approaches in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06238440
• Other study ID #: 2/XIV
• Status: Completed
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: April 2, 2024

Study information

• Verified date: May 2024
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Kinesiotape
• Splints
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Mugla Sitki Koçman University	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visuai Analog Scale (VAS)	Pain	Baseline- after two weeks
Primary	Boston Carpal Tunnel Syndrome Questionnaire	Symptom and Function	Baseline- after two weeks
Primary	Handgrip Dynamometer	Grip	Baseline- after two weeks