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Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia

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ClinicalTrials.gov Identifier: NCT00928564
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine

June 24, 2009
June 26, 2009
October 28, 2016
April 2009
December 2015   (Final data collection date for primary outcome measure)
Visual analog pain score after 6 weekly injections [ Time Frame: 6 to 8 weeks ]
Same as current
Complete list of historical versions of study NCT00928564 on ClinicalTrials.gov Archive Site
Improvement in pelvic floor symptoms as assessed through standardized questionnaires [ Time Frame: 6 weeks to 6 months ]
Same as current
Not Provided
Not Provided
 
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Cross-over Trial

Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic pain. Pelvic floor physical therapy is typically utilized and is at times combined with other therapies such as botox injections, trigger point injections or pudendal blocks. The investigators' study will randomize newly diagnosed patients with PFTM to weekly physical therapy with weekly pudendal blocks or placebo saline injection. Participants randomized to physical therapy with placebo injections that have a visual analog scale score of greater than 4 at 6 weeks may cross-over to the pudendal block group. Final patient assessment will be performed at 6 months to assess durability of response.

Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal pressure and increase pelvic floor strength.

Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in a lower pain score in a shorter time frame, resulting in faster progress through physical therapy.

Participants will be identified within UC Irvine urogynecology and/or pelvic floor physical therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This diagnosis may be secondary to various underlying etiologies including interstitial cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown etiology, etc. At the time of enrollment, participants will be randomized into one of two groups: either standard pelvic floor physical therapy with weekly saline placebo injections or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard physical therapy techniques will be utilized in both groups. Weekly injections of a mixture of a steroid and local anesthetic or saline will be administered depending on the randomization. Injections will be administered by a urogynecology physician. The participant and the treating physical therapist will be blinded to treatment assignment. The participant will be evaluated with for pelvic floor muscle strength and tenderness and will have pain assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months after study enrollment. Vaginal electromyography will be performed and standardized questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be administered at baseline, after 6 weeks of injections and at 6 months after enrollment.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Pelvic Floor Muscle Spasm
  • Drug: Pudendal block
    8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.
    Other Name: regional nerve block anesthesia (drug)
  • Drug: Placebo
    5ml of saline at each block site.
    Other Name: saline
  • Active Comparator: Pudendal Block
    8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.
    Intervention: Drug: Pudendal block
  • Placebo Comparator: Placebo
    5ml of saline at each block site
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
140
May 2016
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-pregnant women over the age of 18 with the diagnosis of pelvic floor tension myalgia that are naive to pelvic floor physical therapy.
  • Able to provide informed consent.
  • Subjects must be willing to accept randomization.

Exclusion Criteria:

  • Previously treated with physical therapy.
  • An allergy to any component within the pudendal block.
  • Bleeding disorders.
  • Active vaginal infection.
  • Inability to complete the questionnaires.
  • Inability to read English (validated questionnaires are available in English only).
  • Inability to complete the follow-up visits.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00928564
2009-6784
Yes
Not Provided
Not Provided
Felicia Lane, University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Felicia Lane, MD University of California, Irvine
University of California, Irvine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP