Shock wave therapy for pain after mastectomy
Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy
This study is testing if shock wave therapy can help women with ongoing pain after breast surgery feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06452615 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of extracorporeal shock wave therapy (ESWT) in treating intercostobrachial neuralgia, a type of neuropathic pain that can occur after a modified radical mastectomy. Sixty female patients aged 40 to 65, who have been experiencing moderate to severe pain for 3-5 months post-surgery, will be randomly assigned to either a treatment group receiving ESWT or a control group. The intervention will last for 8 weeks, aiming to assess improvements in pain and quality of life. The study is conducted at the National Cancer Institute in Cairo, Egypt.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 40 to 65 who have moderate to severe intercostobrachial neuralgia following unilateral modified radical mastectomy.
Not a fit: Patients with current metastases, ongoing chemotherapy or radiotherapy, or certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce pain and improve the quality of life for women suffering from neuropathic pain after mastectomy.
How similar studies have performed: While the specific application of ESWT for this condition may be novel, similar studies using shock wave therapy for other types of pain have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age range will be from 40 to 65 years. 2. All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy. 3. 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. 4. All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm). 5. All patients will have completed their chemotherapy or radiotherapy treatment. 6. All patients enrolled to the study will have their informed consent. Exclusion Criteria: 1. Current metastases. 2. Continuing radiotherapy or chemotherapy. 3. History of allergy to coupling agent. 4. Chronic inflammatory diseases and cellulitis. 5. Venous thrombosis. 6. Local infections. 7. Patients with diabetes mellitus (neuritis). 8. Open skin lesions in the painful area. 9. Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).
Where this trial is running
Cairo
- from the National Cancer Institute — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.