Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
- Conditions
- Neuropathic Pain
- Interventions
- Drug: oxytocin 100 microgramsDrug: 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
- Weight < or equal to 240 pounds
- Neuropathic pain for > 6 months: with primary pain area below the umbilicus
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, then Oxytocin oxytocin 100 micrograms The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT. Oxytocin, then Placebo oxytocin 100 micrograms The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT. Oxytocin, then Placebo Normal 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 Oxytocin Normal 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
Name Time Method Spontaneous Pain From Their Neuropathic Pain Disease 240 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
Name Time Method
Trial Locations
- Locations (1)
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States