Ultrasonographic Evaluation of the Effectiveness of Different Techniques

NCT05415618 | Enrolling By Invitation

• 1 other identifier: 2023-14/01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. The main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel. The pressure that edema puts on the nerve must be controlled in the early period. Edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness. Manual lymphatic drainage (MLD) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility. Nerve gliding exercises are another method used in treatment. By providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated. The aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.

Conditions

Ultrasound Evaluation of the Effect of Manual Lymph Drainage; Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome

Keywords

ultrasonographic evaluation; carpal tunnel syndrome; manual lymph drainage; edema; pain

Outcome Measures

Primary Outcomes (2)

• Ultrasonographic Evaluation

  Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe. With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.

  20 minutes

• Evaluation of symptom severity and functional status

  It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ). 1. The symptom severity scale (BCTQSS) has 11 items that evaluate pain, paresthesia, and weakness. 2. The functional status scale (BCTQ-FS) evaluates the ability to perform manual activities with 8 items. Each item evaluates the increasing severity of symptoms or difficulty with a higher score.

  10 minutes

Study Arms (3)

Kontrol group

ACTIVE COMPARATOR

Device: splint

MLD group

EXPERIMENTAL

Other: Manual lymphatic drainage

Nerve gliding group

EXPERIMENTAL

Other: Nerve gliding

Interventions

Manual lymphatic drainage OTHER

Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.

MLD group

splint DEVICE

In splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks.

Kontrol group

Nerve gliding OTHER

Median nerve gliding exercises as a home exercise program will be performed by the patient 5 days a week for 4 weeks. It will be performed in 6 different consecutive positions of the hand and wrist.

Nerve gliding group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
• Being between 20-55 years old
• Volunteering to participate in the treatment to be given

You may not qualify if:

• Have a systemic inflammatory disease
• Having any disease that may cause polyneuropathy, such as diabetes mellitus
• Cognitive impairment
• Receiving psychotherapy
• Having a pacemaker
• illiterate
• Having a disease affecting the central nervous system
• Having a hearing problem
• Any skin disease that would contraindicate manual lymphatic drainage
• Arterial or venous circulatory disorders that would contraindicate manual lymphatic drainage
• NSAID drug use

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Kutahya Health Science University Hospital

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Edema; Pain

Interventions

Manual Lymphatic Drainage; 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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: March 12, 2024
• Primary Completion: April 12, 2024
• Study Completion: April 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TU (1)