Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02100956
• Other study ID #: IRB00027272
• Status: Terminated
• Phase: Phase 2
• Start date: June 19, 2014
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Description:

Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Weight < or equal to 240 pounds

• Neuropathic pain for > 6 months: with primary pain area below the umbilicus

Exclusion Criteria:

• Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine

• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data

• Pregnancy

• spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for > 3 months at a current dose of > 100 milligram (mg) morphine per day or equivalent.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• oxytocin 100 micrograms
oxytocin 100 micrograms administered intrathecally (IT)
• Normal Saline (preservative free)
Normal Saline (preservative free) administered intrathecally (IT)

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous Pain From Their Neuropathic Pain Disease	Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.	240 minutes post injection