Back to resultsRadiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?
Primary Purpose
Post-Mastectomy Chronic Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radiofrequency
radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Post-Mastectomy Chronic Pain Syndrome
Eligibility Criteria
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 .
Sites / Locations
- Diab
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intercostal nerve group
dorsal root ganglion group
Arm Description
pulsed radiofrequency on intercostal nerves (2-5)
pulsed radiofrequency on dorsal root ganglion (2-5)
Outcomes
Primary Outcome Measures
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) .
Secondary Outcome Measures
The analgesics consumption
The change in analgesics consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03374423
Brief Title
Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?
Official Title
Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves (T2-T5) or Their Corresponding Dorsal Root Ganglia?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Mastectomy Chronic Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intercostal nerve group
Arm Type
Active Comparator
Arm Description
pulsed radiofrequency on intercostal nerves (2-5)
Arm Title
dorsal root ganglion group
Arm Type
Active Comparator
Arm Description
pulsed radiofrequency on dorsal root ganglion (2-5)
Intervention Type
Procedure
Intervention Name(s)
radiofrequency
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency
Intervention Description
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.
Primary Outcome Measure Information:
Title
The intensity of pain
Description
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) .
Time Frame
1 month , 2 month and 3 month post-procedure
Secondary Outcome Measure Information:
Title
The analgesics consumption
Description
The change in analgesics consumption
Time Frame
1 month , 2 month and 3 month post-procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
7644250
Citation
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):61-68. doi: 10.1016/0304-3959(94)00162-8.
Results Reference
background
PubMed Identifier
7669710
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. doi: 10.1093/oxfordjournals.annonc.a059215.
Results Reference
background
PubMed Identifier
8189279
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. doi: 10.3171/jns.1994.80.6.0986.
Results Reference
background
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Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?
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