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 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 . 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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Muscle Spasm
• Intervention / Treatment: Drug: Pudendal block; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UCI Women's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score After 6 Weekly Injections	10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires	The Pelvic Floor Distress Inventory (PFDI) has 20 items and 3 scales, the response scale is from 0-4. Summary scores range from 0-300 with higher scores indicating more distress.	up to 6 months

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (ESTIMATE): June 26, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pelvic pain; physical therapy; pudendal block; Pelvic floor muscle spasm
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Neuromuscular Manifestations; Dyskinesias; Myalgia; Hyperkinesis; Spasm; Muscle Cramp
• Other Study ID Numbers: 2009-6784