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NCT Number: NCT07095569

Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain

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 .

After breast cancer surgery, between 6% and 86% of people may develop tight bands of fibrous tissue under their skin, known as axillary web syndrome. These bands can cause pain in the shoulder area by trying to raise or extend the arm. Shoulder pain is a common side effect of breast cancer surgery and treatment.

Various medical and interventional procedures have been tried for treating postmastectomy shoulder pain, with varying efficacy . Among the interventional procedures that may have a role for treatment.

Innervation of the glenohumeral joint (GHJ) can be divided into anterior and posterior innervation from articular branches of the suprascapular nerve (SN):C5 &6 (posterior-lateral), axillary nerve (AN):C5 &6 (anterior-lateral, inferior, and posteriorlateral), and lateral pectoral nerve (LPN): C5 &6 (anterior superior)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer institute

Cairo, Cairo Governorate, 002, Egypt

Location status: Recruiting

Location contact

suzan Adlan Khedr, MD

CONTACT

[email protected]

01111068300

About this study

The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.

Device

Shoulder individual nerves thermal RF technique: The patient will be put in the sitting position, monitored with electrocardiography, pulse oximetry, and non-invasive blood pressure. after disinfection A high-frequency linear transducer (10-15 Hz) will be placed parallel and cephalad to the spine of the scapula. The probe will be moved from cephalad to caudad until the trapezius and supraspinatus muscles were identified. The suprascapular nerve will be identified as a hyperechogenic structure in the suprascapular fossa deep to the superior transverse scapular ligament. A 10 cm radiofrequency needle, with a 10 mm active tip, will be inserted in plane with the ultrasound beam and advanced to reach the proximity to the nerve. A nerve stimulator was used as an additional nerve-finding modality.

Conservative treatment

Drug

Patients will receive conservative treatment Acetaminophen (paracetamol 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.

Primary outcomes

  1. Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment.

    Time frame: 1 month, 2 months and 3-month intervals following treatment.

    numerical pain rating scale is a measurement tool that uses numbers to represent the intensity of a characteristic or quality, where 0 might represent "no pain" and 100 the highest number represents "the worst pain imaginable".

Secondary outcomes

  1. Measure oxycodone IR (immediate release) consumption

    Time frame: 1 month, 2 months and 3-month intervals following treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

suzan Adlan

CONTACT

[email protected]

+201111068300

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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