Comparison of Different Treatment Approaches in Carpal Tunnel Syndrome

NCT06238440 | Completed DMC

• 1 other identifier: 2/XIV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; Splints; Rigid Taping; Kinesiotape

Keywords

functionality; grip strength; Pain

Outcome Measures

Primary Outcomes (3)

• Visuai Analog Scale (VAS)

  Pain

  Baseline- after two weeks

• Boston Carpal Tunnel Syndrome Questionnaire

  Symptom and Function

  Baseline- after two weeks

• Handgrip Dynamometer

  Grip

  Baseline- after two weeks

Study Arms (4)

Control

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.

Other: Splint and taping methods

Splint

EXPERIMENTAL

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

Rigid taping

EXPERIMENTAL

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

Kinesiotape

EXPERIMENTAL

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

Interventions

Splint and taping methods 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

Control; Kinesiotape; Rigid taping; Splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18-65
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Özge ipek Dongaz

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective. A randomized controlled double-blind study.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: January 2, 2024
• Primary Completion: January 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)