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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05932381
Other study ID # P.T.REC/012/003738
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 5, 2023
Est. completion date October 5, 2023

Study information

Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 5, 2023
Est. primary completion date October 5, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Medical treatment
the patients will receive routine medical treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary hand strength hand held dynamometer will be used for measuring the hand strength up to ten weeks
Primary median nerve conduction velocity median nerve conduction velocity will be measured by electromyography device up to ten weeks
Secondary 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 up to ten weeks
See also
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Active, not recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Completed NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT06323200 - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
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Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
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Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
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Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
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Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
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Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A