Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04016467 |
Other study ID # |
6.7.2018 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 10, 2019 |
Est. completion date |
October 15, 2020 |
Study information
Verified date |
May 2024 |
Source |
University of Mary Hardin-Baylor |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 vestibulodynia (PVD). The objective is to compare the immediate effect of
manipulation and sham manipulation on the results of sensory testing of the external vulva,
or vestibule.
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 then be invited to attend the familiarization and study session and
informed of the need to refrain from alcohol use and keep medication regiment consistent in
the 24 hours prior to the study appointment.
FAMILIARIZATION and CONSENT: During this session, the study protocol will be described and a
written explanation of the study provided to the participant. After any questions have been
addressed, the participant will sign the informed consent statement. Next, the participant
will complete demographic and health questionnaires, which will be reviewed by the
investigators to ensure eligibility criteria are met. If qualified,the participant will
complete additional questionnaires that ask about pain, other symptoms of the pelvis and
perineum and about feelings of anxiety and depression. Along with the questionnaires, a
pelvic and lower extremity secondary screening examination will be performed as described
below.
SECONDARY SCREEN and BASELINE TESTING: During the lower extremity screening examination, the
participant will be asked to bend and straighten their spine, stretch in specific ways with
the spine and legs and report if these motions provoked discomfort or pain. The pelvic exam
and baseline testing is to ensure that the participant has pain in the perineum (area that is
wiped after toileting). This will be tested in 2 ways, one using a sterile cotton tipped swab
(q-tip test) and the other with a pressure sensing device called an algometer. One trained
pelvic floor Physical Therapist (PT1) investigator will perform these tests. While
investigator PT1 waits outside, the participant will undress from the waist down then lay
under a sheet. PT1 will enter and perform the sensory tests during which the participant's
pelvic floor and vestibule will be exposed in a similar manner to receiving a gynecologic
exam. PT1 will use a q-tip to touch specific points around the vaginal opening (vestibule)
and ask the participant to report any pain on a scale of 0 (none)-10 (worst). Next, a
pressure algometer will be used to measure the amount of pressure tolerated on the most
painful q-tip spot. This algometer has a flat disc, the size of a pencil eraser, that is
covered to ensure cleanliness. Then the participant's lower body will be draped.
Participant's with provoked pain are eligible to continue; those without are not eligible to
continue in the study and will be done.
INTERVENTION and REPEAT BASELINE TESTING: The eligible participants are randomly assigned, by
participant number, into one of the two testing groups. One group will receive a sham
thoracic spine manipulation (ThS) and the other, a thoracic spine manipulation (ThM). During
the thoracic intervention, the participant will lay on their back with arms crossed. The
second PT (PT2), who is blinded to the results of the pain testing, will position one hand
along the participant's thoracic spine and the other on the participant's crossed arms to
apply a posterior motion to the participant's spine. This will be small motion that may be
done quickly or slowly. After the technique, the participant will continue to rest on their
back, while PT1 returns to repeat testing of the vestibule with the q-tip and algometer in
the same manner as previously described. Then participation is finished.