Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?

Not Applicable

Completed

• Conditions: Post-Mastectomy Chronic Pain Syndrome
• Interventions: Procedure: radiofrequency

• Registration Number: NCT03374423
• Lead Sponsor: Assiut University

Brief Summary

neuropathic pain can occur following any surgical procedure on the breast ..

Detailed Description

chronic pain affects the daily lives of post-surgical breast cancer patients. many of these patients were undertreated for pain and generally obtained poor pain relief.treated patients with chronic thoracic segmental pain including patients with post-mastectomy pain syndrome by radiofrequency for dorsal root ganglion reported longterm pain relief.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2018-01-01
• Primary Completion: 2019-04-01
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients with chronic post-mastectomy pain for at least 3 months post operatively.
• patients with visual analogue scale for pain score > 4
• patients treated with more than one line of anti-neuropathic drugs.

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Exclusion Criteria

• patient refusal.
• coagulopathy.
• chest and back deformity.
• infection at the introduction site of the needle .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intercostal nerve group	radiofrequency	pulsed radiofrequency on intercostal nerves (2-5)
dorsal root ganglion group	radiofrequency	pulsed radiofrequency on dorsal root ganglion (2-5)

Primary Outcome Measures

Name	Time	Method
The intensity of pain	1 month , 2 month and 3 month post-procedure	A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the intensity of pain. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left handend of the line to the point that the patient marks.; Scoring and interpretation : using a ruler, score is determined by measuring the distance(mm) on the10 cm line between the "no pain" anchor and the patient's mark ,providing a range of scores from (0_100).; A higher score indicates greater pain intensity. the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) .

Secondary Outcome Measures

Name	Time	Method
The analgesics consumption	1 month , 2 month and 3 month post-procedure	The change in analgesics consumption

Trial Locations

Locations (1)

Diab; 🇪🇬 Assiut, Assuit, Egypt