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

Post-Mastectomy Chronic Pain Syndrome Clinical Trial

Official title:

Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves (T2-T5) or Their Corresponding Dorsal Root Ganglia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374423
• Other study ID #: ENPH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Exclusion Criteria:

• patient refusal.

• coagulopathy.

• chest and back deformity.

• infection at the introduction site of the needle .

Related Conditions & MeSH terms

• Chronic Pain
• Post-Mastectomy Chronic Pain Syndrome

Intervention

Procedure:
• radiofrequency
The procedure will be done under propofol sedation, under fluoroscopic guidance. The image intensifier will be rotated in a cephalo-caudal direction until the endplates of the thoracic vertebrae are aligned and the transverse processes became discernable from the ribs. For the intercostal nerve group, the radiofrequency needle 10 cm with 10 ml active tip will then inserted to contact the lower edge of the transverse process of (T2-T5), the needle is walked off to obtain sensory stimulation between 0.3-0.6 mv and motor stimulation less than 1.2 mv .five cycle of pulsed radiofrequency will be delivered.
• radiofrequency
The procedure will be done under propofol sedation, under fluoroscopic guidance.for dorsal root ganglion group, radiofrequency needle 10 cm with 10 ml active tip will inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walked into the thoracic intervertebral foramen. Once correct needle position is confirmed, test stimulation will be performed at 50 Hz, during which time the needles will slightly redirected to optimize stimulation, the point of maximum stimulation will be designated to be the location of the dorsal root ganglion. five cycle of pulsed radiofrequency will be delivered.

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Stevens PE, Dibble SL, Miaskowski C. Prevalence, characteristics, and impact of postmastectomy pain syndrome: an investigation of women's experiences. Pain. 1995 Apr;61(1):61-8. — View Citation

Stolker RJ, Vervest AC, Groen GJ. The treatment of chronic thoracic segmental pain by radiofrequency percutaneous partial rhizotomy. J Neurosurg. 1994 Jun;80(6):986-92. — View Citation

Tasmuth T, von Smitten K, Hietanen P, Kataja M, Kalso E. Pain and other symptoms after different treatment modalities of breast cancer. Ann Oncol. 1995 May;6(5):453-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of pain	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) .	1 month , 2 month and 3 month post-procedure
Secondary	The analgesics consumption	The change in analgesics consumption	1 month , 2 month and 3 month post-procedure