VulvodyniaSpManipPPNCT04016467
Effect of Spinal Manipulation on Vulvar Pain
A study testing Thoracic manipulation in people with Vulvodynia and Perineal Pain, run by University of Mary Hardin-Baylor at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vulvodynia, Perineal Pain, Vulvar Pain
- What is being tested?
- Thoracic manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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 Inclusion Criteria: demonstrates provoked vestibule pain to q-tip testing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrity Rehab and Home Health
Copperas Cove, Texas, 76522
About this study
Official title: The Effect of Thoracic Spinal Manipulation on Vulvar Vestibule Pain: a Controlled Clinical Study
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.
Read the 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 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.
- Conditions
- Vulvodynia, Perineal Pain, Vulvar Pain
- Being tested
- Thoracic manipulation, Sham thoracic treatment
- Keywords
- Spinal Manipulation
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic manipulationOther
High velocity, small amplitude thrust treatment to spine that elicits a neurophysiologic response.
Sham thoracic treatmentOther
Hand placement on thorax without thrust.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Manipulation (ThM) | Experimental | Will undergo spinal manipulation between pain assessment pre and post. Receives: Other: Thoracic manipulation |
| Sham thoracic treatment (ThS) | Sham comparator | Sham manipulation between pain assessment pre and post Receives: Other: Sham thoracic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern
Participant report on NPRS
Measured: Pre and immediately post thoracic intervention. No longer term follow-up is planned.
Secondary outcomes (1)
Change in peak pressure algometer
Nm2 pressure reading of provoked pain on most painful point
Measured: Pre and immediately post thoracic intervention. No longer term follow-up is planned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start10 May 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: Lack of participants in available recruitment area
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- Integrity Rehab and Home Health
- Responsible party
- Sponsor
- Investigators
- PATRICIA NELSON, PT, ScD, Principal investigator, University of Mary Hardin-Baylor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016467
- Sponsor's protocol ID
- 6.7.2018
- Acronym
- SpManipPP
- Status last verified
- May 2024
- First submitted
- 1 Jul 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing is planned
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracic Spinal Manipulation on Vulvar Vestibule Pain: a Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04016467
- Acronym / sponsor ID
- SpManipPP / 6.7.2018
- Conditions
- Vulvodynia, Perineal Pain, Vulvar Pain
- Keywords
- Spinal Manipulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants in available recruitment area
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- Integrity Rehab and Home Health
- Study start
- 10 May 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Thoracic Manipulation (ThM) | Experimental | Other: Thoracic manipulationWill undergo spinal manipulation between pain assessment pre and post. |
| Sham thoracic treatment (ThS) | Sham comparator | Other: Sham thoracic treatmentSham manipulation between pain assessment pre and post |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic manipulationHigh velocity, small amplitude thrust treatment to spine that elicits a neurophysiologic response. | Other | Thoracic Manipulation (ThM) |
| Sham thoracic treatmentHand placement on thorax without thrust. | Other | Sham thoracic treatment (ThS) |
Primary outcome
Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern
Time frame: Pre and immediately post thoracic intervention. No longer term follow-up is planned.
Participant report on NPRS
1 secondary outcome
Change in peak pressure algometer
Time frame: Pre and immediately post thoracic intervention. No longer term follow-up is planned
Results and safety
The study was stopped early (reason given: Lack of participants in available recruitment area). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. No data sharing is planned
Related trials for Vulvodynia
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A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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Vestibulectomy Surgical Techniques Comparison Study
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Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
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A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PATRICIA NELSON, PT, ScD principal investigator
University of Mary Hardin-Baylor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic manipulation in people with Vulvodynia and Perineal Pain, run by University of Mary Hardin-Baylor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of participants in available recruitment area). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern (time frame: Pre and immediately post thoracic intervention. No longer term follow-up is planned.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.