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

NCT ID: NCT05932381

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-10-05

Brief Summary

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

Detailed Description

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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

Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

complete decongestive therapy and routine medical treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
opaque sealed envelope

Study Groups

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Complete decongestive therapy

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

Group Type EXPERIMENTAL

Complete decongestive therapy

Intervention Type OTHER

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

Intervention Type OTHER

the patients will receive routine medical treatment

medical treatment

the patients will receive routine medical treatment for ten weeks

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type OTHER

the patients will receive routine medical treatment

Interventions

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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

Intervention Type OTHER

Medical treatment

the patients will receive routine medical treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abd Elmohsen Ali

principle investigator Sara Abd Elmohsen Ali

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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P.T.REC/012/003738

Identifier Type: -

Identifier Source: org_study_id

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