Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNational Cancer Institute, Egypt
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age (18-65) Years.
ASA physical status (II- III).
Patients with post mastectomy irradiation shoulder pain.
Body mass index (BMI): (20-40) kg/m2.
Disqualifiers
Patient refusal.
Known sensitivity or contraindication to drugs used in the study.
Pregnancy.
Recent myocardial infarction.
Trial design
Design model
Parallel
Treatments tested in this trial
(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.
DeviceShoulder 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
DrugPatients 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder iExperimental treatment 1 intervention
Group B: Group 2 (Control): Patients will receive conservative treatment.Active comparator 1 intervention
Trial outcomes
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.
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".
Time frame
1 month, 2 months and 3-month intervals following treatment.Secondary outcomes
1
Measure oxycodone IR (immediate release) consumption
Time frame
1 month, 2 months and 3-month intervals following treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov