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
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
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
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
Learn more about this trial
Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
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