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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00928564
First received: June 24, 2009
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pelvic Floor Muscle Spasm
Drug: Pudendal block
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Cross-over Trial

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Visual analog pain score after 6 weekly injections [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in pelvic floor symptoms as assessed through standardized questionnaires [ Time Frame: 6 weeks to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
Placebo Comparator: Placebo
5ml of saline at each block site
Drug: Placebo
5ml of saline at each block site.
Other Name: saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928564

Contacts
Contact: Felicia Lane, MD 714.456.8564 fgeas@uci.edu

Locations
United States, California
UCI Women's Healthcare Recruiting
Orange, California, United States, 92868
Contact: Jennifer Nakano    714-456-6846    jnakano@uci.edu   
Principal Investigator: Felicia Lane, MD         
Sub-Investigator: Karen Noblett, MD         
Sub-Investigator: Danielle Markle, MD         
Sub-Investigator: Ene George, MD         
Sub-Investigator: Jennifer Rhee, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Felicia Lane, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Felicia Lane, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00928564     History of Changes
Other Study ID Numbers: 2009-6784
Study First Received: June 24, 2009
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Pelvic floor muscle spasm
Pelvic pain
physical therapy
pudendal block

Additional relevant MeSH terms:
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014