- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139445
Manual Lymphatic Drainage for Pain, Muscle Strength, and Sensation
Effect of Manual Lymphatic Drainage on Pressure Pain Threshold, Pain Tolerance, Grip and Pinch Strength, and Two-point Discrimination
To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults.
healthy young adults were included in the study. Before and after MLD and plasebo touchs, the same physiotherapist performed PPT and pain tolerance measurements, muscle strength measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point discrimination (2PD) evaluation with an esthesiometer.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey, 42130
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being aged 18-30 years
- Volunteering to participate in the study
Exclusion Criteria:
- Having any skin disease
- Having a history of neurological and/or orthopedic disease
- Having a significant scar or burn tissue in the upper extremity
- Having any condition that would prevent communication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Group
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Manual lymphatic drainage (MLD), one of the components of complex decongestive physiotherapy, is a gentle massage technique with proven positive effects on lymphatic circulation.
MLD can be applied to different parts of the body (e.g., arms, legs, neck, abdomen, and trunk), with a different technique for each region (stationary circle, scoop, pump, and rotary)
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Placebo Comparator: Plasebo Group
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random superficial touches not involved in any manual technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain threshold (PPT)
Time Frame: 5 minutes
|
PPT measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points.
Measurements will be repeated three times.
The average of these three measurements will be used for analysis.
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5 minutes
|
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pain tolerance
Time Frame: 5 minutes
|
pain tolerance measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points.The highest tolerable pressure will be used in the measurement and it will be recorded.
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5 minutes
|
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Evaluation of Hand Grip Strength
Time Frame: 5 minutes
|
The Jamar will be used to measure hand grip strength.Three measurements will be made at one-minute intervals, and the average values will be recorded
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5 minutes
|
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Evaluation Finger Pinch Strength
Time Frame: 5 minutes
|
A pinchmeter (Baseline®) will be used to measure finger pinch strength.
Three measurements will be made at one-minute intervals, and the average values will be recorded
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5 minutes
|
|
Two-point discrimination (2PD)
Time Frame: 10 minutes
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This evaluation will be performed using an esthesiometer with the participants in the sitting position with their eyes closed.
Evaluation will be made from the biceps medial to the elbow.
The contact time of the two-point stimulation will be adjusted to be approximately 1-2 seconds, and approximately 3-5 seconds will be waited between each stimulation.
The shortest distance felt between two points provided the static 2PD value
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/25-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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