Actively Recruiting

Phase Not Applicable
Age: 40Years - 65Years
FEMALE
NCT06452615

Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

Led by Cairo University · Updated on 2024-08-27

60

Participants Needed

1

Research Sites

15 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

PURPOSE: The main objective of the study is: to evaluate the therapeutic effect of ESWT on intercostobrachial neuralgia post-mastectomy. BACKGROUND: Intercostobrachial neuralgia post-mastectomy is thought to develop from surgical damage to the intercostobrachial nerve, this nerve is injured in 80-100 % of mastectomy patients who undergo axillary lymph nodes dissection. Pain that is localized in the axilla, medial upper arm, breast, and/or chest wall significantly affects the patient's mood, everyday activities, and social functioning, causing a heavy economic burden on healthcare systems. If poorly treated, patients may develop an immobilized arm, which can lead to severe lymphedema, frozen shoulder syndrome, and complex regional pain syndrome. HYPOTHESES: It will be hypothesized that: Shock wave therapy has no effect in improving intercostobrachial neuralgia post-mastectomy.

CONDITIONS

Official Title

Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy

Who Can Participate

Age: 40Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 40 to 65 years
  • Suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy
  • Experiencing moderate or severe burning, tingling, numbness, or electric nerve pain lasting 3 to 5 months after mastectomy
  • Pain located in the anterior chest wall, axilla, and upper medial arm with altered skin sensitivity
  • Having unilateral mild to moderate lymphedema with a 4 cm arm circumference difference
  • Completed chemotherapy or radiotherapy treatment
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Presence of current metastases
  • Ongoing chemotherapy or radiotherapy treatment
  • History of allergy to coupling agent used in treatment
  • Chronic inflammatory diseases or cellulitis
  • Venous thrombosis
  • Local infections in the painful area
  • Diabetes mellitus causing nerve inflammation
  • Open skin lesions in the painful area
  • Other causes of arm pain such as brachial plexus neuropathy from radiotherapy, cervical radiculopathy, or shoulder joint peri-capsulitis

AI-Screening

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Trial Site Locations

Total: 1 location

1

from the National Cancer Institute

Cairo, Egypt

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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