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Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Phase 2
Terminated
Conditions
Neuropathic Pain
Interventions
Drug: oxytocin 100 micrograms
Drug: Normal Saline (preservative free)
Registration Number
NCT02100956
Lead Sponsor
Wake Forest University Health Sciences
Brief 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.

Detailed 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 & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
8
Inclusion Criteria
  • Weight < or equal to 240 pounds
  • Neuropathic pain for > 6 months: with primary pain area below the umbilicus
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo, then Oxytocinoxytocin 100 microgramsThe subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
Oxytocin, then Placebooxytocin 100 microgramsThe subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
Oxytocin, then PlaceboNormal Saline (preservative free)The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
Placebo, then OxytocinNormal Saline (preservative free)The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
Primary Outcome Measures
NameTimeMethod
Spontaneous Pain From Their Neuropathic Pain Disease240 minutes post injection

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wake Forest School of Medicine

🇺🇸

Winston-Salem, North Carolina, United States

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