DyspareuniaPhase 4NCT02022722
Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
A Phase 4 study testing Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride and Pelvic Rehabilitation in people with Dyspareunia, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dyspareunia
- What is being tested?
- Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride and Pelvic Rehabilitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pelvic pain
- pelvic floor myalgia
- dyspareunia
- female
- age > 18 years
Who cannot join
- interstitial cystitis
- vaginal lesions / ulcerations
- prior trigger point injections in the past 6 months
- prior pelvic rehabilitation in the past 6 months
- laparoscopically documented endometriosis / pelvic adhesions or adhesive disease
- documented pelvic inflammatory disease identified within the past 6 months
- documented sexually transmitted disease within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Division of Urogynecology, University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Dani Zoorob, MD, 513-562-9080, zoorobdg@ucmail.uc.edu
About this study
Official title: Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
Read the detailed description
Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
- Conditions
- Dyspareunia
- Being tested
- Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride, Pelvic Rehabilitation
- Keywords
- Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia
- Medical subject headings
- Dyspareunia, Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger Point Injections Triamcinolone Acetonide, Bupivacaine HydrochlorideDrug
Also called Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml, Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml
The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.
Pelvic RehabilitationProcedure or surgery
Also called Pelvic floor massage
Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Rehabilitation | Active comparator | Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks Receives: Procedure: Pelvic Rehabilitation |
| Trigger Point Injections | Active comparator | Trigger point injections will be administered on weekly basis for a total of 6 weeks Receives: Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale.
Measured: Baseline, Week 10
Secondary outcomes (1)
Change in sexual function between visit 1 and visit 10
Change in sexual function based on the female sexual function index (19 questions, one final score, maximum score of 36) where the patients fill a questionnaire prior to the first treatment session and after the completion of the treatment at week 10.
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patty Brisben Foundation For Women's Sexual Health
- Responsible party
- Principal investigator, Mary South, University of Cincinnati
- Investigators
- Mary South, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022722
- Sponsor's protocol ID
- UC IRB Study #: 2013-0677
- Other IDs
- Patty Brisben Foundation
- Status last verified
- Dec 2013
- First submitted
- 21 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
PubMed 8598948Rao SS, Paulson J, Mata M, Zimmerman B. Clinical trial: effects of botulinum toxin on Levator ani syndrome--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2009 May 1;29(9):985-91. doi: 10.1111/j.1365-2036.2009.03964.x. Epub 2009 Feb 13.
PubMed 19222415Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62. doi: 10.1002/nau.20393.
PubMed 17195176Jarvis SK, Abbott JA, Lenart MB, Steensma A, Vancaillie TG. Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):46-50. doi: 10.1111/j.1479-828X.2004.00163.x.
PubMed 15089868
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
- ClinicalTrials.gov ID
- NCT02022722
- Acronym / sponsor ID
- UC IRB Study #: 2013-0677
- Conditions
- Dyspareunia
- Keywords
- Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Patty Brisben Foundation For Women's Sexual Health
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 30 Dec 2013 (estimated)
- 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 this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
Detailed description
Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Rehabilitation | Active comparator | Procedure: Pelvic RehabilitationPelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks |
| Trigger Point Injections | Active comparator | Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine HydrochlorideTrigger point injections will be administered on weekly basis for a total of 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pelvic pain
- pelvic floor myalgia
- dyspareunia
- female
- age > 18 years
Key exclusion criteria (7 listed)
- interstitial cystitis
- vaginal lesions / ulcerations
- prior trigger point injections in the past 6 months
- prior pelvic rehabilitation in the past 6 months
- laparoscopically documented endometriosis / pelvic adhesions or adhesive disease
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 |
|---|---|---|
| Trigger Point Injections Triamcinolone Acetonide, Bupivacaine HydrochlorideAlso: Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml, Bupivacaine Hydrochloride-Strength 0.5%, Volume 18mlThe mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature. | Drug | Trigger Point Injections |
| Pelvic RehabilitationAlso: Pelvic floor massagePelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy | Procedure or surgery | Pelvic Rehabilitation |
Primary outcome
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
Time frame: Baseline, Week 10
Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale.
1 secondary outcome
Change in sexual function between visit 1 and visit 10
Time frame: Baseline, Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Background: PubMed 8598948Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
- Results publication: PubMed 19222415Rao SS, Paulson J, Mata M, Zimmerman B. Clinical trial: effects of botulinum toxin on Levator ani syndrome--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2009 May 1;29(9):985-91. doi: 10.1111/j.1365-2036.2009.03964.x. Epub 2009 Feb 13.
- Results publication: PubMed 17195176Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62. doi: 10.1002/nau.20393.
- Results publication: PubMed 15089868Jarvis SK, Abbott JA, Lenart MB, Steensma A, Vancaillie TG. Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):46-50. doi: 10.1111/j.1479-828X.2004.00163.x.
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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.
Mary South, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride and Pelvic Rehabilitation in people with Dyspareunia, run by University of Cincinnati 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Dec 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dani Zoorob, MD (5135629080, zoorobdg@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale (time frame: Baseline, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022722, which also lists 4 linked publications.
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 30 Dec 2013.