Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF., conservative treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial
Overview
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)
Detailed description
The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.
Interventions
- Device (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 identified. The suprascapular nerve will be identified as a hyperechogenic structure in - Drug 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
- 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.]
Secondary outcome measures (1)
- Measure oxycodone IR (immediate release) consumption [Time frame: 1 month, 2 months and 3-month intervals following treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Cancer institute — Cairo
Identifiers
NCT: NCT07095569 · IORG003381