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

Primary Purpose

Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complete decongestive therapy
Medical treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring complete decongestive therapy, carpal tunnel syndrome, upper limb lymphedema

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Complete decongestive therapy

    medical treatment

    Arm Description

    the patients will receive complete decongestive therapy twice a week for ten weeks

    the patients will receive routine medical treatment for ten weeks

    Outcomes

    Primary Outcome Measures

    hand strength
    hand held dynamometer will be used for measuring the hand strength
    median nerve conduction velocity
    median nerve conduction velocity will be measured by electromyography device

    Secondary Outcome Measures

    pain intensity
    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

    Full Information

    First Posted
    June 27, 2023
    Last Updated
    June 27, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05932381
    Brief Title
    Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
    Acronym
    CDT
    Official Title
    Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 5, 2023 (Anticipated)
    Primary Completion Date
    October 5, 2023 (Anticipated)
    Study Completion Date
    October 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema
    Keywords
    complete decongestive therapy, carpal tunnel syndrome, upper limb lymphedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    complete decongestive therapy and routine medical treatment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelope
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Complete decongestive therapy
    Arm Type
    Experimental
    Arm Description
    the patients will receive complete decongestive therapy twice a week for ten weeks
    Arm Title
    medical treatment
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive routine medical treatment for ten weeks
    Intervention Type
    Other
    Intervention Name(s)
    Complete decongestive therapy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Medical treatment
    Intervention Description
    the patients will receive routine medical treatment
    Primary Outcome Measure Information:
    Title
    hand strength
    Description
    hand held dynamometer will be used for measuring the hand strength
    Time Frame
    up to ten weeks
    Title
    median nerve conduction velocity
    Description
    median nerve conduction velocity will be measured by electromyography device
    Time Frame
    up to ten weeks
    Secondary Outcome Measure Information:
    Title
    pain intensity
    Description
    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
    Time Frame
    up to ten weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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