NCT05394870

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

May 19, 2022

Last Update Submit

July 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    15 minutes

  • 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.

    10 minutes

  • 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

    15 minutes

Study Arms (2)

study group

EXPERIMENTAL
Other: manual lymphatic drainage (massage)Other: Splint treatment

control group

ACTIVE COMPARATOR
Other: Splint treatment

Interventions

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.

study group

The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients

control groupstudy group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Centrum, 43040, Turkey (Türkiye)

Location

Related Publications (1)

  • Akdeniz Leblebicier M, Cihan E, Yaman F, Sahbaz Pirincci C, Ture A, Kavuncu V. Can manual lymphatic drainage be a new treatment option in mild-moderate carpal tunnel syndrome? A randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):584-593. doi: 10.1016/j.jht.2024.12.020. Epub 2025 Feb 6.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Manual Lymphatic DrainageMassage

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 27, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 10, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations