Actively Recruiting
Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study
Led by Cairo University · Updated on 2025-06-04
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the role of pulsed radiofrequency treatment applied to either the brachial plexus or individual shoulder nerves in managing chronic shoulder pain after mastectomy. Breast cancer, one of the most common cancers worldwide, often requires surgery, and many patients develop persistent shoulder pain afterward. The study explores new treatment options since pulsed radiofrequency of the brachial plexus has not yet been tested for this type of shoulder pain. Participants are randomly assigned into three groups: one receives pulsed radiofrequency of the brachial plexus combined with steroid injections, another receives pulsed radiofrequency of individual shoulder nerves with steroids, and a control group receives conservative treatment including paracetamol, pregabalin, and oxycodone at specified doses. The study looks at these interventions over a 24-week period after surgery. During the study, researchers monitor pain levels using the Visual Analogue Scale, assess functional improvement, track pain medication use, and evaluate patient satisfaction and quality of life. They also record any complications related to the treatments. Participants are followed for 24 weeks postoperatively to gather these outcomes and better understand the impact of these therapies on post-mastectomy shoulder pain.
CONDITIONS
Brief Title
Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status II or III
- Patients experiencing post mastectomy shoulder pain
- Body mass index (BMI) between 20 and 40 kg/m2
- Patients taking maximum daily dose of tramadol (450 mg) and still in pain
You will not qualify if you...
- Patient refusal to participate
- Known sensitivity or contraindication to drugs used in the study
- Pregnancy
- Recent myocardial infarction
- Hemodynamically unstable condition
- Presence of local or systemic sepsis
- Psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive one of the following interventions: pulsed radiofrequency of brachial plexus with steroids injection, pulsed radiofrequency of shoulder individual nerves with steroids injection, or conservative treatment with medications such as paracetamol, pregabalin, and oxycodone.
1 baseline visit and regular follow-up visits during treatment
Duration - Up to 24 weeks post treatment
Participants are monitored to assess changes in pain, functional improvement, analgesic consumption, patient satisfaction, quality of life, and incidence of complications following treatment.
Periodic visits for assessments up to 24 weeks post treatment
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 11796
Actively Recruiting
Research Team
Y
Yasmina S Ismail, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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