Skip to main content
OpenTrials
Completed

NCT Number: NCT05490420

Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome

This study is aimed to investigate the effects of upper extremity manual lymphatic drainage, which is applied to remove edema from the carpal tunnel region in addition to conventional exercise therapy in Carpal tunnel syndrome patients on findings of clinical, ultrasonographic, and electrophysiological.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emel Mete

Istanbul, 34000, Turkey (Türkiye)

About this study

Thirtyfour volunteer participants between aged 40 and 60 years, who met the inclusion criteria, will be included in the study. Participants will be randomly divided into two groups experimental and control groups. While the control group will receive only conventional exercises, the experimental group will receive both conventional exercises and upper extremity manual lymphatic drainage. A total of 3 measurements will be made before the treatment, after the treatment and 1 month after the end of the treatment. Symptom severity will be evaluated via Boston carpal tunnel syndrome questionnaire, grip strength via hand dynamometer, pressure pain threshold via digital algometer device, cross-sectional area of the median nerve via ultrasound, and median nerve conduction velocity via superficial EMG device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People aged between 40-60 years
  • Having been diagnosed with carpal tunnel syndrome (CTS) at least 6 months ago or having symptoms related to carpal tunnel syndrome for at least 6 months
  • Having mild (median nerve sensory conduction velocity below 40 m/sec) and moderate (median nerve sensory conduction velocity below 40 m/sec and median motor distal latency 4 ms and above) CTS according to electrophysiological findings
  • Not having received medical treatment and/or physiotherapy for CTS in the last 6 months

Exclusion criteria

  • Having cervical radiculopathy
  • Having thoracic outlet syndrome
  • Presence of systemic disease that may lead to CTS, such as diabetes or thyroid disease
  • Pregnancy
  • Presence of anemia
  • Having a history of CTS surgery
  • Presence of radial or ulnar nerve sensory-motor lesions accompanying the present condition
  • Presence of lymphedema
  • Having severe (Sensory nerve action potential cannot be obtained) and severe (Sensory nerve action potential cannot be obtained, but combined muscle action potential is not present) CTS according to electrophysiological findings

Treatment and study plan

Manual Lymphatic Drainage (MLD)

Other

MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions.

Primary outcomes

  1. Symptom severity

    Time frame: Change from baseline symptom severity at week 6 and 10.

    1- Symptom severity will be evaulated with Boston carpal tunnel questionnaire (BCTQ). BCTQ comprises 11 items of Symptom Severity Scale (SSS) measuring pain, paresthesia, numbness, nocturnal symptoms and feeling of weakness plus another 8 items of Functional Status Scale (FSS) measuring difficulties in performing daily activities. Scales ranged from 1-5 representing normal to worst symptoms or disabilities. Higher scores indicate greater symptom severity and disability.

  2. Grip strength

    Time frame: Change from baseline grip strength at week 6 and 10.

    2- Grip strength will be assessed with a digital hand dynamometer. The subject will seat with feet positioned on the floor, shoulder adducted, and the elbow bent at a 90-degree angle with the forearm parallel to the floor. Maximal isometric grip strength will be measured in kilograms. It is a reliable method for measuring grip strength.

  3. Pressure pain threshold (PPT)

    Time frame: Change from baseline pressure pain threshold at week 6 and 10.

    PPT, the minimal amount of pressure where a sense of pressure changes to pain, will be measured with an electronic algometer over the median nerve in the wrist area. The pressure will be applied approximately at a rate of 30 kPa/sec for 30 seconds. Participants will be instructed to press the switch when the sensation changed from pressure to pain.

  4. Cross-sectional area of the median nerve

    Time frame: Change from baseline cross-sectional area of the median nerve at week 6 and 10.

    US images will be obtained by a neurologist trained in peripheral nerve US. The nerve will be imaged using a Biosound Esaote MyLab 70 equipped with an 18-MHZ linear-array transducer. The median nerve will be imaged in cross-section at the distal wrist crease (carpal tunnel inlet) and 12 cm proximal to this point in the forearm.

  5. Sensory Velocity of median nerve

    Time frame: Change from baseline Sensory Velocity of median nerve at week 6 and 10.

    Sensory Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques.

  6. Motor velocity of median nerve

    Time frame: Change from baseline motor velocity of median nerve at week 6 and 10.

    Motor Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2022
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.