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.
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. Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.
Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
Patients 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 .
Cairo University
Cairo, Egypt
RECRUITINGChanges 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.
Time frame: 24 weeks post postoperatively
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.
Time frame: 24 weeks post postoperatively
Analgesic consumption
Analgesic consumption will be recorded
Time frame: 24 weeks post postoperatively
Patient satisfaction
Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed
Time frame: 24 weeks post postoperatively
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.
Time frame: 24 weeks post postoperatively
Incidence of complications
Incidence of complications will be recorded
Time frame: 24 weeks post postoperatively
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