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

Pelvic Floor Muscle Spasm research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pelvic Floor Muscle Spasm

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pudendal block8ml 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:Placebo5ml of saline at each block site.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pudendal Block8ml 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.

Placebo5ml of saline at each block site

Study Status

Completed

Start Date: April 2009

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Visual analog pain score after 6 weekly injections

Secondary Outcome: Improvement in pelvic floor symptoms as assessed through standardized questionnaires

Study sponsors, principal investigator, and references

Principal Investigator: Felicia Lane, MD

Lead Sponsor: University of California, Irvine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00928564

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