Back to resultsClinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
Primary Purpose
Carpal Tunnel Syndrome, Electrophysical Evaluation, Manual Lymphatic Drainage
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual lymphatic drainage (massage)
Splint treatment
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
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
Sites / Locations
- Kutahya Health Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
Outcomes
Primary Outcome Measures
pressure pain threshold
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
Boston Carpal Tunnel Questionnaire (BCTQ)
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.
Electrodiagnostic evaluation
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05394870
Brief Title
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
Official Title
Clinical and Electrophysiological Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Electrophysical Evaluation, Manual Lymphatic Drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
manual lymphatic drainage (massage)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Splint treatment
Intervention Description
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
Primary Outcome Measure Information:
Title
pressure pain threshold
Description
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
Time Frame
15 minutes
Title
Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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.
Time Frame
10 minutes
Title
Electrodiagnostic evaluation
Description
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
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kutahya Health Science University
City
Kütahya
State/Province
Centrum
ZIP/Postal Code
43040
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
We'll reach out to this number within 24 hrs