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

NCT ID: NCT07002944

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2026-06-30

Brief Summary

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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

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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 .

Conditions

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Pulsed Radiofrequency Shoulder Individual Nerves Brachial Plexus Chronic Post Mastectomy Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brachial plexus pulsed radiofrequency group

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Group Type OTHER

Brachial plexus pulsed radiofrequency

Intervention Type OTHER

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Sholder individual nerves pulsed radiofrequency group

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Group Type OTHER

Sholder individual nerves pulsed radiofrequency

Intervention Type OTHER

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Control group

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 .

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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 .

Interventions

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Brachial plexus pulsed radiofrequency

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Intervention Type OTHER

Sholder individual nerves pulsed radiofrequency

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Intervention Type 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 .

Intervention Type OTHER

Other Intervention Names

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Paracetamol +pregabalin +oxycodone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmina Sayed

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management Department, National Cancer Institute, Cairo University, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasmina S Ismail, Master

Role: CONTACT

00201223014453

Facility Contacts

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Yasmina S Ismail

Role: primary

00201223014453

Other Identifiers

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AP2412-201-087-194

Identifier Type: -

Identifier Source: org_study_id

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