Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01996384
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2013-11-18
Brief Title:
Provoked Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Sponsor:
Oregon College of Oriental Medicine
Organization:
Oregon College of Oriental Medicine
Study Overview
Official Title:
Acupuncture Augmentation of Lidocaine for the Treatment of Provoked Localized vulvodynia-a Feasibility and Acceptability Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators research project is a randomized controlled single-blinded feasibility pilot study The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia PLV with acupuncture and 5 lidocaine cream Lidocaine is a numbing agent and common first treatment for this disorder Acupuncture is a treatment commonly used for other pain disorders The investigators will compare two types of acupuncture classical and non-classical as a treatment for PLV in addition to 5 lidocaine cream Researchers want to determine if acupuncture is acceptable and convenient to women with PLV The investigators hypothesize that classical acupuncture and 5 lidocaine cream will be better than non-classical acupuncture and 5 lidocaine cream to decrease PLV pain
Detailed Description:
This is a randomized controlled single-blinded pilot trial to study the feasibility and acceptability of acupuncture and 5 lidocaine Patients will be recruited from the patient population of the Oregon Health Science University Vulvar Health Clinic Thirty 30 patients with PLV will be enrolled as study participants into the study Fifteen 15 will be allocated in the treatment classical acupuncture 5 lidocaine group and fifteen 15 will be allocated in the control non-classical acupuncture 5 lidocaine group via a computer generated randomization program to balance allocation based on four variables pain intensity smoking status body mass index and pain duration
The acupuncturist will interview each patient and perform an exam of the pulse and tongue A standardized acupuncture treatment will be assigned and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points with or without mild electrical stimulation All study participants will self-apply lidocaine cream to their genital region four times daily during the study
The acupuncturist will interview each patient and perform an exam of the pulse and tongue A standardized acupuncture treatment will be assigned and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points with or without mild electrical stimulation All study participants will self-apply lidocaine cream to their genital region four times daily during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None