Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema (CDT)

June 27, 2023 updated by: Sara Abd Elmohsen Ali, Cairo University
this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

lymphedema is a chronic condition characterized by lymphatic vessel ectasia and valve dysfunction, followed by the reflux of lymphatic fluid into the interstitial space. Lymph stasis may lead to a chronic inflammatory process, resulting in adipose tissue differentiation and fibro adipose tissue deposition. One consequence of post-mastectomy lymphedema may be the development of nerve entrapments. One example is median nerve entrapment in the carpal canal, or carpal tunnel syndrome (CTS). many studies assessed the relationship of CTS as a risk factor for developing lymphedema, other studies stated the possibility of lymphedema as a potential contributor to CTS development. Complex decongestive treatment of breast cancer-related lymphoedema is an accepted strategy and is considered as an international standard for treatment. A previous review concluded that complex decongestive therapy has a positive impact on the volume of arm and quality of life in different stages of lymphedema.sixty females will be allocated randomly to two groups; first one will receive decongestive therapy and the second one will receive the routine medical treatment for ten weeks

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age will range between 20- 40 years.
  • Only females will participate in the study.
  • All patients have carpal tunnel syndrome post upper limb lymphedema.

Exclusion Criteria:

  • Diabetes mellitus.
  • Individuals with cardiopulmonary conditions.
  • Individuals undergoing radiation therapy or chemotherapy.
  • Hepatic or pancreatic diseases.
  • Sensory impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complete decongestive therapy
the patients will receive complete decongestive therapy twice a week for ten weeks
Other: Complete decongestive therapy
the patients will receive Complete decongestive therapy in the form of intermittent pneumatic compression, Exercising, bandaging, and manual lymphatic drainage with Pressures of 50, 80, and 120 mmHg and timing 5, 20, and 50 secs
Other: Medical treatment
the patients will receive routine medical treatment
Active Comparator: medical treatment
the patients will receive routine medical treatment for ten weeks
Other: Medical treatment
the patients will receive routine medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand strength
Time Frame: up to ten weeks
hand held dynamometer will be used for measuring the hand strength
up to ten weeks
median nerve conduction velocity
Time Frame: up to ten weeks
median nerve conduction velocity will be measured by electromyography device
up to ten weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to ten weeks
Visual analogue scale which is 100 mm horizontal line will be used for measuring pain intensity. the scale has no pain on the left side and worst pain on the right side
up to ten weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 5, 2023

Primary Completion (Estimated)

October 5, 2023

Study Completion (Estimated)

October 5, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003738

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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