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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient refusal.

Known sensitivity or contraindication to drugs used in the study.

Pregnancy.

Recent myocardial infarction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brachial plexus pulsed radiofrequency

    Other intervention

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

  • Sholder individual nerves pulsed radiofrequency

    Other intervention

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

  • Control

    Other intervention

    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 .

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Brachial plexus pulsed radiofrequency groupOther 1 intervention
Group B: Sholder individual nerves pulsed radiofrequency groupOther 1 intervention
Group C: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes 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

Secondary outcomes

1

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
2

Analgesic consumption

Analgesic consumption will be recorded

Time frame
24 weeks post postoperatively
3

Patient satisfaction

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

Time frame
24 weeks post postoperatively
4

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

Other outcomes

Sponsors and contacts

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