NCT03374423

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

December 12, 2017

Last Update Submit

July 3, 2019

Conditions

Post-Mastectomy Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The analgesics consumption

    1 month , 2 month and 3 month post-procedure

Study Arms (2)

intercostal nerve group

ACTIVE COMPARATOR

pulsed radiofrequency on intercostal nerves (2-5)

Procedure: radiofrequency

dorsal root ganglion group

ACTIVE COMPARATOR

pulsed radiofrequency on dorsal root ganglion (2-5)

Procedure: radiofrequency

Interventions

radiofrequencyPROCEDURE

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.

intercostal nerve group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

Location

Related 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):61-68. doi: 10.1016/0304-3959(94)00162-8.

    PMID: 7644250BACKGROUND

  • 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.

    PMID: 7669710BACKGROUND

  • 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.

    PMID: 8189279BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 15, 2017

Study Start

January 1, 2018

Primary Completion

April 1, 2019

Study Completion

July 1, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

EG(1)