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Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage

Primary Purpose

Ultrasound Evaluation of the Effect of Manual Lymph Drainage, Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual lymphatic drainage
splint
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ultrasound Evaluation of the Effect of Manual Lymph Drainage focused on measuring ultrasonographic evaluation, carpal tunnel syndrome, manual lymph drainage, edema, pain

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 circulatory disorders that would contraindicate manual lymphatic drainage
  • NSAID drug use

Sites / Locations

  • Kutahya Health Science University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Kontrol group

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

Ultrasonographic Evaluation
Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe. With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.
Evaluation of symptom severity and functional status
It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ). 1. The symptom severity scale (BCTQSS) has 11 items that evaluate 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 higher score.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
August 16, 2022
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05415618
Brief Title
Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage
Official Title
Clinical and Ultrasonographic 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
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 30, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. The main cause of median nerve compression and carpal tunnel syndrome is the increase in volume in the carpal tunnel. The pressure exerted by the edema on the nerve should be brought under control in the early period. Edema that continues beyond the inflammatory process may contribute to the fibrotic phase, delaying healing and even causing complications such as pain and stiffness. Manual lymph drainage (MLD) is a special technique that includes light massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, reducing edema and pain, regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating changes in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may occur after a traumatic situation, reducing edema, which is a predisposing factor for pain, and increasing mobility. The aim of this study is to determine the effectiveness of manual lymphatic drainage on clinical and ultrasonographic findings in carpal tunnel syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Evaluation of the Effect of Manual Lymph Drainage, Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome
Keywords
ultrasonographic evaluation, carpal tunnel syndrome, manual lymph drainage, edema, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kontrol group
Arm Type
Active Comparator
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Manual lymphatic drainage
Intervention Description
Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.
Intervention Type
Device
Intervention Name(s)
splint
Intervention Description
In splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks.
Primary Outcome Measure Information:
Title
Ultrasonographic Evaluation
Description
Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe. With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.
Time Frame
20 minutes
Title
Evaluation of symptom severity and functional status
Description
It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ). 1. The symptom severity scale (BCTQSS) has 11 items that evaluate 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 higher score.
Time Frame
10 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 circulatory disorders that would contraindicate manual lymphatic drainage NSAID drug use
Facility Information:
Facility Name
Kutahya Health Science University Hospital
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage

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