Status:
TERMINATED
Effect of Spinal Manipulation on Vulvar Pain
Lead Sponsor:
University of Mary Hardin-Baylor
Collaborating Sponsors:
Integrity Rehab and Home Health
Conditions:
Vulvodynia
Perineal Pain
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The purpose of the study is to determine the effect of thoracic spine manipulation on vestibule pain as determined by sensory testing (q-tip and pressure algometry) in a group of women with provoked v...
Detailed Description
PRE-SCREENING: Participants expressing interest in this study will be interviewed to determine if eligibility criteria to participate in this study are met. If that is the case, the participant will t...
Eligibility Criteria
Inclusion
- Provides written and dated informed consent to participate in the study.
- Is between the ages of 18-40 years.
- Reports pain in the pelvis and/or vestibule (area that is wiped after using the toilet) that has been present for ≥ 6 weeks.
- Has not had treatment for pelvic or vestibule pain in the 6 months prior to study participation.
- Is willing and able to comply with study protocol.
- Is healthy and free from disease, as determined by a health history questionnaire and screening exam.
- Agrees to abstain from alcohol consumption 24 hours prior to the study protocol.
- Reports a consistent regimen of pain medication use in the 6 weeks prior to the study protocol. This includes both prescription and over the counter medications.
- Secondary demonstrates provoked vestibule pain to q-tip testing.
Exclusion
- Is currently pregnant, or attempting to become pregnant, as the intervention is contraindicated for this population.
- Fails the health history, spine screen; or does not demonstrate provoked vestibule pain with q-tip test.
- Has undergone any spine or pelvic girdle surgery in the 12 months prior to the study.
- Has ever had sling/mesh placement to the pelvic region.
- Has been diagnosed with osteopenia, osteoporosis, acute infection or arthritis flare, or other condition that could weaken the bony skeleton.
- Has ever had a thoracic spine fracture.
- Has had a change in any prescription or over-the-counter medications used for pain in the 6 weeks prior to the study.
- Any other condition or adverse event in which study investigator recommend removal from the study.
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04016467
Start Date
May 10 2019
End Date
October 15 2020
Last Update
May 16 2024
Active Locations (1)
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1
Integrity Rehab and Home Health
Copperas Cove, Texas, United States, 76522