About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient refusal.
Known sensitivity or contraindication to drugs used in the study.
Pregnancy.
Recent myocardial infarction.
Trial design
Parallel
Treatments tested in this trial
Brachial plexus pulsed radiofrequency
Other interventionPatients will receive pulsed radiofrequency of brachial plexus with steroids injection.
Sholder individual nerves pulsed radiofrequency
Other interventionPatients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
Control
Other interventionPatients 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 .
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Functional improvement
This is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into 4 categories (0-25%) ≈ no or minimal functional improvement, (\> 25- 50%) ≈ mild improvement, (\> 50-75%) ≈ moderate improvement, and (\>75-100%) ≈ marked improvement.
Analgesic consumption
Analgesic consumption will be recorded
Patient satisfaction
Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed
The impact of treatment on the quality of life of the patient
The impact of treatment on the quality of life of the patient, which will be assessed by the SF-36 questionnaire.
Sponsors and contacts
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