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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490420
• Other study ID #: 2022/0344
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2022
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 30, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• manual lymphatic drainage (MLD)
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.

Locations

Country	Name	City	State
Turkey	Emel Mete	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity	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.	Change from baseline symptom severity at week 6 and 10.
Primary	Grip strength	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.	Change from baseline grip strength at week 6 and 10.
Primary	Pressure pain threshold (PPT)	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.	Change from baseline pressure pain threshold at week 6 and 10.
Primary	Cross-sectional area of the median nerve	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.	Change from baseline cross-sectional area of the median nerve at week 6 and 10.
Primary	Sensory Velocity of median nerve	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.	Change from baseline Sensory Velocity of median nerve at week 6 and 10.
Primary	Motor velocity of median nerve	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	Change from baseline motor velocity of median nerve at week 6 and 10.