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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05932381

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema	Other: Complete decongestive therapy Other: Medical treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

complete decongestive therapy and routine medical treatmentcomplete decongestive therapy and routine medical treatment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

opaque sealed envelope

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Oct 5, 2023

Anticipated Study Completion Date :

Oct 5, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

hand strength [up to ten weeks]
hand held dynamometer will be used for measuring the hand strength
median nerve conduction velocity [up to ten weeks]
median nerve conduction velocity will be measured by electromyography device

Secondary Outcome Measures

pain intensity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Abd Elmohsen Ali, principle investigator Sara Abd Elmohsen Ali, Cairo University

ClinicalTrials.gov Identifier:

NCT05932381

Other Study ID Numbers:

P.T.REC/012/003738

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sara Abd Elmohsen Ali, principle investigator Sara Abd Elmohsen Ali, Cairo University

complete decongestive therapy

carpal tunnel syndrome

upper limb lymphedema

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Lymphedema

Study Results

No Results Posted as of Jul 6, 2023