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Recruiting NCT07002944

Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain

No phase Interventional Pulsed Radiofrequency Shoulder Individual Nerves Brachial Plexus Chronic Post Mastectomy

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: Brachial plexus pulsed radiofrequency, Sholder individual nerves pulsed radiofrequency, Control.
Who it may be relevant to
Registry conditions: Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Chronic, Post Mastectomy. Basic parameters: 18 years — 65 years · All.
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

Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study

Overview

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.

Detailed description

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 .

Interventions

  • Other Brachial plexus pulsed radiofrequency
    Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.
  • Other Sholder individual nerves pulsed radiofrequency
    Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
  • Other Control
    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 .

Primary outcome measures

  • Changes in visual Analogue Scale (VAS ) [Time frame: 24 weeks post postoperatively]
Secondary outcome measures (5)
  • Functional improvement [Time frame: 24 weeks post postoperatively]
  • Analgesic consumption [Time frame: 24 weeks post postoperatively]
  • Patient satisfaction [Time frame: 24 weeks post postoperatively]
  • The impact of treatment on the quality of life of the patient [Time frame: 24 weeks post postoperatively]
  • Incidence of complications [Time frame: 24 weeks post postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients on maximum daily dose tramadol ( 450mg ) and still in pain

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
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07002944 · AP2412-201-087-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗