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Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain 60

Not yet recruiting
Clinical Trial NCT07095569 is an interventional study for Breast Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2025 and continue until the study accrues 60 participants. Led by National Cancer Institute, Egypt, this study is expected to complete by 30 August 2026. The latest data from ClinicalTrials.gov was last updated on 31 July 2025.
Brief Summary
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 b...

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

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

Conditions
Breast Cancer
Other Study IDs
  • IORG003381
NCT ID Number
NCT07095569
Start Date (Actual)
2025-08-01
Last Update Posted
2025-07-31
Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i
Thermal RF therapy will be performed under ultrasound guidance.
(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.
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 identif...Show More
Active ComparatorGroup 2 (Control): Patients will receive conservative treatment.
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.
conservative treatment
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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".
1 month, 2 months and 3-month intervals following treatment.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Measure oxycodone IR (immediate release) consumption
1 month, 2 months and 3-month intervals following treatment.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  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.

  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.
National Cancer Institute, Egypt logoNational Cancer Institute, Egypt3019 active studies to explore
Study Responsible Party
Suzan Adlan Abdelrahman, Principal Investigator, Assistant professor, National Cancer Institute, Egypt
Study Central Contact
Contact: suzan Adlan, +201111068300, [email protected]
No location data.