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

• ClinicalTrials.gov Identifier: NCT05932381
• Recruitment Status: Not yet recruiting
• First Posted: July 6, 2023
• Last Update Posted: July 6, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): Sara Abd Elmohsen Ali, Cairo University

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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: complete 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
• Estimated Study Start Date: July 5, 2023
• Estimated Primary Completion Date: October 5, 2023
• Estimated Study Completion Date: October 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. pain intensity [ Time Frame: 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

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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: July 6, 2023
• Last Update Posted: July 6, 2023
• Last Verified: June 2023

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

Keywords provided by Sara Abd Elmohsen Ali, Cairo University:

complete decongestive therapy; carpal tunnel syndrome; upper limb lymphedema

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Lymphedema; Lymphatic Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries