Pulsed radiofrequency to shoulder nerves versus the brachial plexus for chronic post‑mastectomy shoulder pain

Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study

This will test whether pulsed radiofrequency to the brachial plexus or to individual shoulder nerves helps reduce chronic shoulder pain after mastectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cairo University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cairo)
• Trial ID: NCT07002944 on ClinicalTrials.gov

What this trial studies

This interventional trial compares pulsed radiofrequency (PRF) applied to the brachial plexus versus PRF applied to individual shoulder nerves, with a control group, in patients with chronic post‑mastectomy shoulder pain. Adults meeting inclusion criteria are enrolled at Cairo University and receive image‑guided PRF interventions, with clinical follow-up to record pain and functional outcomes. Eligibility includes age 18–65, BMI 20–40 kg/m2, ASA II–III status, and persistent pain despite up to 450 mg/day tramadol. The approach is based on shoulder innervation from C5–C7 and builds on prior case reports of PRF for brachial plexus‑related neuropathic pain, while brachial plexus PRF for shoulder pain is a novel application.

Who should consider this trial

Good fit: Adults 18–65 years with chronic post‑mastectomy shoulder pain, BMI 20–40 kg/m2, ASA II–III, and ongoing pain despite up to 450 mg/day tramadol are the intended participants.

Not a fit: Patients who are pregnant, hemodynamically unstable, recently had a myocardial infarction, have local or systemic sepsis, psychiatric illness, or known contraindications to the procedures are unlikely to benefit or to be eligible.

Why it matters

Potential benefit: If successful, the procedure could provide longer-lasting, non‑opioid pain relief and improved shoulder function for people with chronic post‑mastectomy shoulder pain.

How similar studies have performed: PRF to the brachial plexus for shoulder pain is novel, but PRF has shown benefit in case reports and small series for other brachial plexus‑related and neuropathic upper‑limb pain.

Eligibility criteria

Inclusion Criteria:

* Age (18-65) Years.
* American Society of Anesthesiologists (ASA) physical status (II- III).
* Patients with post mastectomy shoulder pain.
* Body mass index (BMI): (20-40) kg/m2.
* Patients on maximum daily dose tramadol ( 450mg ) and still in pain

Exclusion Criteria:

* Patient refusal.
* Known sensitivity or contraindication to drugs used in the study.
* Pregnancy.
* Recent myocardial infarction.
* Hemodynamically unstable.
* Local and systemic sepsis.
* Psychiatric illness.

Where this trial is running

Cairo

• Cairo University — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Yasmina S Ismail, Master

Conditions: Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Chronic, Post Mastectomy, Shoulder Pain