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NCT Number: NCT07002944

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

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.

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Key information

Conditions

Pulsed Radiofrequency Arthralgia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Graft vs Host Disease Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Musculoskeletal Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Post Mastectomy Respiratory Tract Diseases Shoulder Individual Nerves Brachial Plexus Shoulder Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Algohary M Tantawy, MD

SUB_INVESTIGATOR

Essam A Mahran, MD

SUB_INVESTIGATOR

Suzan Adlan, MD

SUB_INVESTIGATOR

Taher S Thabet, MD

SUB_INVESTIGATOR

Yasmina S Ismail

CONTACT

[email protected]

00201223014453

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brachial plexus pulsed radiofrequency

Other

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

Sholder individual nerves pulsed radiofrequency

Other

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

Control

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 .

Other names: Paracetamol +pregabalin +oxycodone

Primary outcomes

  1. Changes in visual Analogue Scale (VAS )

    Time frame: 24 weeks post postoperatively

    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

  1. Functional improvement

    Time frame: 24 weeks post postoperatively

    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.

  2. Analgesic consumption

    Time frame: 24 weeks post postoperatively

    Analgesic consumption will be recorded

  3. Patient satisfaction

    Time frame: 24 weeks post postoperatively

    Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed

  4. The impact of treatment on the quality of life of the patient

    Time frame: 24 weeks post postoperatively

    The impact of treatment on the quality of life of the patient, which will be assessed by the SF-36 questionnaire.

  5. Incidence of complications

    Time frame: 24 weeks post postoperatively

    Incidence of complications will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmina S Ismail, Master

CONTACT

[email protected]

00201223014453

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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