NCT06139445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

12 days

First QC Date

May 25, 2023

Last Update Submit

January 26, 2024

Conditions

Keywords

Manual lymphatic drainagepain thresholdpain tolerancetwo-point discriminationmuscle strength

Outcome Measures

Primary Outcomes (5)

  • pressure pain threshold (PPT)

    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.

    5 minutes

  • pain tolerance

    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.

    5 minutes

  • Evaluation of Hand Grip Strength

    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

    5 minutes

  • Evaluation Finger Pinch Strength

    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

    5 minutes

  • Two-point discrimination (2PD)

    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

Study Arms (2)

Study Group

EXPERIMENTAL
Other: Manual Lymphatic Drainage

Plasebo Group

PLACEBO COMPARATOR
Other: Plasebo Group

Interventions

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)

Study Group

random superficial touches not involved in any manual technique

Plasebo Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being aged 18-30 years
  • Volunteering to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42130, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

May 25, 2023

First Posted

November 18, 2023

Study Start

November 8, 2023

Primary Completion

November 20, 2023

Study Completion

November 30, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations