Shoulder denervation to relieve post-mastectomy radiation shoulder pain

Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial

This trial will try thermal radiofrequency nerve treatment on the shoulder to reduce radiation-related shoulder pain in adults after mastectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: National Cancer Institute, Egypt (Academic / other)
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT07095569 on ClinicalTrials.gov

What this trial studies

This interventional trial tests thermal radiofrequency (TRF) denervation of individual shoulder nerves to treat shoulder pain following mastectomy and radiotherapy. Eligible participants will receive TRF targeting articular branches of the suprascapular and axillary nerves or receive conservative treatment, with procedures and follow-up at the National Cancer Institute in Cairo. Adults 18–65 years with ASA II–III status and BMI 20–40 are eligible, while people with active infection, recent myocardial infarction, hemodynamic instability, pregnancy, or major psychiatric illness are excluded. Pain levels and shoulder function will be monitored over follow-up to determine the clinical effect of the intervention.

Who should consider this trial

Good fit: Adults aged 18–65 with post-mastectomy irradiation shoulder pain, ASA physical status II–III, and BMI between 20 and 40 kg/m2 are ideal candidates.

Not a fit: Patients who are pregnant, hemodynamically unstable, have active local or systemic infection, recent myocardial infarction, or significant psychiatric illness are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the procedure could reduce chronic shoulder pain and improve arm mobility after mastectomy and radiation.

How similar studies have performed: Radiofrequency denervation has been used for other shoulder pain syndromes with mixed results, so applying TRF specifically for post-mastectomy radiation shoulder pain is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age (18-65) Years.
2. ASA physical status (II- III).
3. Patients with post mastectomy irradiation shoulder pain.
4. Body mass index (BMI): (20-40) kg/m2.

Exclusion Criteria:

1. Patient refusal.
2. Known sensitivity or contraindication to drugs used in the study.
3. Pregnancy.
4. Recent myocardial infarction.
5. Hemodynamically unstable.
6. Local and systemic sepsis.
7. Psychiatric illness.

Where this trial is running

Cairo, Cairo Governorate

• National Cancer institute — Cairo, Cairo Governorate, Egypt (Recruiting)

Study contacts

• Study coordinator: suzan Adlan

Conditions Breast Cancer