NCT00928564

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pelvic Floor Muscle Spasm

Interventions

Type	Name	Description
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.
DRUG	Placebo	5ml of saline at each block site.

Timeline

• Start date: 2009-04-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2009-06-26
• Last updated: 2021-02-10
• Results posted: 2021-02-10

Locations

1 site across 1 country: United States