Ultrasonographic Evaluation of the Effectiveness of Diffe... | NCT05415618

Studies
Ultrasonographic Evaluation of the Effectiveness of Different Techniques

NCT05415618

Sponsor

Selcuk University

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

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

Interventions

Manual lymphatic drainage
splint
Nerve gliding

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2024Actual

Primary Completion Date

Apr 12, 2024Estimated

Completion Date

Apr 30, 2024Estimated

First Submitted Date

Jun 8, 2022

First Submission Date that Met QC Criteria

Jun 8, 2022

First Posted Date

Jun 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 increased volume in the carpal tunnel. The pressure that edema puts on the nerve must be controlled in the early period. Edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness. Manual lymphatic drainage (MLD) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility. Nerve gliding exercises are another method used in treatment. By providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated. The aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Kontrol group	Active Comparator	Device: splint
MLD group	Experimental	Other: Manual lymphatic drainage
Nerve gliding group	Experimental	Other: Nerve gliding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manual lymphatic drainage	Other	Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.	MLD group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	20 minutes
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.	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kutahya Health Science University Hospital		Kütahya		43100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome
D004487	Edema
D010146	Pain

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073297	Manual Lymphatic Drainage
D013165	Splints

Ancestor Terms

ID	Term
D008405	Massage
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies

Browse Leaves

Not provided

Browse Branches

Not provided