Back to resultsEffects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual lymphatic drainage (MLD)
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, manual lymphatic drainage, surface electromyography
Eligibility Criteria
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
Sites / Locations
- Emel Mete
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control
experimental
Arm Description
17 participants who meet the inclusion criteria will be applied conventional exercise which includes nerve gliding and tendon gliding exercises. And also sham (placebo) upper extremity manual lymphatic drainage will be applied. Sham (placebo) manual lymphatic drainage will include only classical massage not manual lymphatic drainage techniques. Participants will be treated for a total of 6 weeks, 2 days a week. Each session will last approximately 20-30 minutes, and the exercises will be performed in 3 sets with 10 repetitions.
17 participants who meet the inclusion criteria will be applied both conventional exercise and upper 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. Within the scope of this research, an application will be made to cover the entire upper extremity lymphatic system. MLD will last approximately 20-30 minutes. Conventional exercise, which includes nerve gliding and tendon gliding exercises, will be performed in 3 sets with 10 repetitions. Participants will be treated for a total of 6 weeks, 2 days a week.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05490420
First Posted
August 4, 2022
Last Updated
September 7, 2023
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT05490420
Brief Title
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
Official Title
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
June 3, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, manual lymphatic drainage, surface electromyography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Masking Description
participant will be masked.
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
17 participants who meet the inclusion criteria will be applied conventional exercise which includes nerve gliding and tendon gliding exercises. And also sham (placebo) upper extremity manual lymphatic drainage will be applied. Sham (placebo) manual lymphatic drainage will include only classical massage not manual lymphatic drainage techniques. Participants will be treated for a total of 6 weeks, 2 days a week. Each session will last approximately 20-30 minutes, and the exercises will be performed in 3 sets with 10 repetitions.
Arm Title
experimental
Arm Type
Experimental
Arm Description
17 participants who meet the inclusion criteria will be applied both conventional exercise and upper 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. Within the scope of this research, an application will be made to cover the entire upper extremity lymphatic system. MLD will last approximately 20-30 minutes. Conventional exercise, which includes nerve gliding and tendon gliding exercises, will be performed in 3 sets with 10 repetitions. Participants will be treated for a total of 6 weeks, 2 days a week.
Intervention Type
Other
Intervention Name(s)
manual lymphatic drainage (MLD)
Intervention Description
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 Outcome Measure Information:
Title
Symptom severity
Description
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.
Time Frame
Change from baseline symptom severity at week 6 and 10.
Title
Grip strength
Description
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.
Time Frame
Change from baseline grip strength at week 6 and 10.
Title
Pressure pain threshold (PPT)
Description
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.
Time Frame
Change from baseline pressure pain threshold at week 6 and 10.
Title
Cross-sectional area of the median nerve
Description
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.
Time Frame
Change from baseline cross-sectional area of the median nerve at week 6 and 10.
Title
Sensory Velocity of median nerve
Description
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.
Time Frame
Change from baseline Sensory Velocity of median nerve at week 6 and 10.
Title
Motor velocity of median nerve
Description
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
Time Frame
Change from baseline motor velocity of median nerve at week 6 and 10.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emel Mete
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
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