Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage

Sponsor

Selcuk University (Other)

Overall Status

Completed

CT.gov ID

NCT05415618

Collaborator

(none)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

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 the increase in volume in the carpal tunnel. The pressure exerted by the edema on the nerve should be brought under control in the early period. Edema that continues beyond the inflammatory process may contribute to the fibrotic phase, delaying healing and even causing complications such as pain and stiffness. Manual lymph drainage (MLD) is a special technique that includes light massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, reducing edema and pain, regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating changes in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may occur after a traumatic situation, reducing edema, which is a predisposing factor for pain, and increasing mobility. The aim of this study is to determine the effectiveness of manual lymphatic drainage on clinical and ultrasonographic findings in carpal tunnel syndrome.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Evaluation of the Effect of Manual Lymph Drainage Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome	Other: Manual lymphatic drainage Device: splint	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome

Actual Study Start Date :

Jun 6, 2022

Actual Primary Completion Date :

Jul 6, 2022

Actual Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Kontrol group	Device: splint 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.
Experimental: Treatment group	Other: Manual lymphatic drainage Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks. Device: splint 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.

Arm

Intervention/Treatment

Active Comparator: Kontrol group

Device: splint

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.

Experimental: Treatment group

Other: Manual lymphatic drainage

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

Device: splint

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.

Outcome Measures

Primary Outcome Measures

Ultrasonographic Evaluation [20 minutes]
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.
Evaluation of symptom severity and functional status [10 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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