Extracorporeal Shock Wave Therapy on Neuropathic Pain Post Mastectomy
Recruiting now · Not applicable
Conditions studied: Neuropathic Pain
In brief
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.
Key facts
- Study ID
- NCT06452615
- Run by
- Cairo University
- People needed
- 60
- Starts
- 2024-06-15
- Expected to finish
- 2024-10-01
- Last updated by the study team
- 2024-08-27
Who can join
Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age range will be from 40 to 65 years.
- All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
- All patients suffering from moderate or severe pain of burning, tingling, numbness, and electric nature persisting for 3-5 months following mastectomy, in the anterior chest wall, axilla, upper medial arm with altered sensitivity of the skin in the painful area.
- All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
- All patients will have completed their chemotherapy or radiotherapy treatment.
- All patients enrolled to the study will have their informed consent.
You may not qualify if…
- Current metastases.
- Continuing radiotherapy or chemotherapy.
- History of allergy to coupling agent.
- Chronic inflammatory diseases and cellulitis.
- Venous thrombosis.
- Local infections.
- Patients with diabetes mellitus (neuritis).
- Open skin lesions in the painful area.
- Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).
Where it is running
- from the National Cancer Institute — Cairo, Egypt (enrolling)
Full record on ClinicalTrials.gov
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