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Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain

Primary Purpose

Dyspareunia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
Pelvic Rehabilitation
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pelvic pain
  • pelvic floor myalgia
  • dyspareunia
  • female
  • age > 18 years

Exclusion Criteria:

  • 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

Sites / Locations

  • Division of Urogynecology, University of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pelvic Rehabilitation

Trigger Point Injections

Arm Description

Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks

Trigger point injections will be administered on weekly basis for a total of 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2013
Last Updated
December 27, 2013
Sponsor
University of Cincinnati
Collaborators
Patty Brisben Foundation For Women's Sexual Health
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1. Study Identification

Unique Protocol Identification Number
NCT02022722
Brief Title
Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
Official Title
Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Patty Brisben Foundation For Women's Sexual Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia
Keywords
Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Rehabilitation
Arm Type
Active Comparator
Arm Description
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
Arm Title
Trigger Point Injections
Arm Type
Active Comparator
Arm Description
Trigger point injections will be administered on weekly basis for a total of 6 weeks
Intervention Type
Drug
Intervention Name(s)
Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
Other Intervention Name(s)
Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml, Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml
Intervention Description
The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.
Intervention Type
Procedure
Intervention Name(s)
Pelvic Rehabilitation
Other Intervention Name(s)
Pelvic floor massage
Intervention Description
Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
Primary Outcome Measure Information:
Title
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
Description
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.
Time Frame
Baseline, Week 10
Secondary Outcome Measure Information:
Title
Change in sexual function between visit 1 and visit 10
Description
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.
Time Frame
Baseline, Week 10

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pelvic pain pelvic floor myalgia dyspareunia female age > 18 years Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dani Zoorob, MD
Phone
5135629080
Email
zoorobdg@ucmail.uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary South, MD
Phone
5135629080
Email
southmm@ucmai.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary South, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Urogynecology, University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dani Zoorob, MD
Phone
513-562-9080
Email
zoorobdg@ucmail.uc.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
8598948
Citation
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.
Results Reference
background
PubMed Identifier
19222415
Citation
Rao 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 Reference
result
PubMed Identifier
17195176
Citation
Langford 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 Reference
result
PubMed Identifier
15089868
Citation
Jarvis 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.
Results Reference
result

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Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain

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