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

NCT00928564 | Completed Results DMC

• 1 other identifier: 2009-6784
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Muscle Spasm

Keywords

Pelvic floor muscle spasm; Pelvic pain; physical therapy; pudendal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires

  up to 6 months

Study Arms (2)

Pudendal Block

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

5ml of saline at each block site

Drug: Placebo

Interventions

Pudendal block DRUG

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.

Also known as: regional nerve block anesthesia (drug)

Pudendal Block

Placebo DRUG

5ml of saline at each block site.

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Pelvic Pain

Interventions

Pharmaceutical Preparations; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Felicia Lane
• Organization: UC Irvine

kbacca@uci.edu

17144566155

Study Officials

• Felicia Lane, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: February 10, 2021
• Results First Posted: February 10, 2021

Record last verified: 2021-01

Locations

US (1)