Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage

July 5, 2022 updated by: Emine Cihan, Selcuk University

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

When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome

Study Overview

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Centrum
      • Kütahya, Centrum, Turkey, 43040
        • Kutahya Health Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 circulation disorder that would contraindicate manual lymphatic drainage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
Experimental: study group
Patients will begin treatment with manual lymphatic drainage in the affected extremity. In this context, while the patients are in the supine hook position, lymph drainage will be applied first to the neck and then to the abdomen. After the stimulation of the central lymph nodes, the lymph circulation will be increased by stimulating the axillary lymph nodes of the relevant region. First, the proximal part will be drained and it will be advanced towards the distal. Drainage will be repeated depending on the edema at the distal forearm-wrist level.
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pressure pain threshold
Time Frame: 15 minutes
Each evaluation will be repeated 3 times with 10 seconds between measurements, and the data will be recorded by taking the average of the last two measurements (15). The patients will be evaluated by measuring the transverse carpal ligament, radioulnar joint and extensor digitorum muscle with an algometer before and at the end of the treatment. measurements will be recorded in kg/cm2
15 minutes
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 10 minutes
BCTQ, a self-report measure of CTS, evaluates two domains: 1. The symptom severity scale (BCTQSS) has 11 items that assess 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 high score.
10 minutes
Electrodiagnostic evaluation
Time Frame: 15 minutes
Median motor nerve latency, median motor nerve conduction velocity, compound muscle action potential amplitude will be measured at both levels. Median sensory nerve conduction studies will be performed by antidromic recording with a superficial electrode from the 3rd finger and a stimulus will be given from the wrist 14 cm proximal. Median sensory nerve latency, median sensory nerve conduction velocity and sensory nerve action potential will be calculated for both applications. nerve potentials will be calculated in m/sec
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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