Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain

Not Applicable

Recruiting

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

• Registration Number: NCT07002944
• Lead Sponsor: Cairo University

Brief Summary

this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.

Detailed Description

Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post-mastectomy pain syndrome.

Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .

Study Timeline

• Study First Submitted: 2025-05-24
• Status Verified: 2025-06
• Study Start: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in visual Analogue Scale (VAS )	24 weeks post postoperatively	Changes in visual Analogue Scale (VAS )for assessment of pain relief. A 100 mm horizontal line version will be used with 2 ends (left-end means no pain and right-end means the worst pain). This version is preferred in research studies for chronic pain status.

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	24 weeks post postoperatively	Analgesic consumption will be recorded
Patient satisfaction	24 weeks post postoperatively	Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed
Incidence of complications	24 weeks post postoperatively	Incidence of complications will be recorded
Functional improvement	24 weeks post postoperatively	This is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into 4 categories (0-25%) ≈ no or minimal functional improvement, (\> 25- 50%) ≈ mild improvement, (\> 50-75%) ≈ moderate improvement, and (\>75-100%) ≈ marked improvement.
The impact of treatment on the quality of life of the patient	24 weeks post postoperatively	The impact of treatment on the quality of life of the patient, which will be assessed by the SF-36 questionnaire.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt