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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03374423
Enrollment
60
Registered
2017-12-15
Start date
2018-01-01
Completion date
2019-07-01
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Mastectomy Chronic Pain Syndrome

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.

Interventions

PROCEDUREradiofrequency

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
The intensity of pain1 month , 2 month and 3 month post-procedureA 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

MeasureTime frameDescription
The analgesics consumption1 month , 2 month and 3 month post-procedureThe change in analgesics consumption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026