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

NCT07002944 | Recruiting

• 1 other identifier: AP2412-201-087-194
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes in visual Analogue Scale (VAS )

  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.

  24 weeks post postoperatively

Secondary Outcomes (5)

• Functional improvement

  24 weeks post postoperatively

• Analgesic consumption

  24 weeks post postoperatively

• Patient satisfaction

  24 weeks post postoperatively

• The impact of treatment on the quality of life of the patient

  24 weeks post postoperatively

• Incidence of complications

  24 weeks post postoperatively

Study Arms (3)

Brachial plexus pulsed radiofrequency group

OTHER

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Other: Brachial plexus pulsed radiofrequency

Sholder individual nerves pulsed radiofrequency group

OTHER

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Other: Sholder individual nerves pulsed radiofrequency

Control group

ACTIVE COMPARATOR

Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs .

Other: Control

Interventions

Brachial plexus pulsed radiofrequency OTHER

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Brachial plexus pulsed radiofrequency group

Sholder individual nerves pulsed radiofrequency OTHER

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Sholder individual nerves pulsed radiofrequency group

Control OTHER

Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs .

Also known as: Paracetamol +pregabalin +oxycodone

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yasmina S Ismail, Master

CONTACT

00201223014453; Yasminasayed.Ys@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management Department, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 4, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)