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Completed

NCT Number: NCT00928564

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

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.

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Key information

Conditions

Pelvic Floor Muscle Spasm Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCI Women's Healthcare

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: regional nerve block anesthesia (drug)

Placebo

Drug

5ml of saline at each block site.

Other names: saline

Primary outcomes

  1. Visual Analog Pain Score After 6 Weekly Injections

    Time frame: up to 8 weeks

    10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain

Secondary outcomes

  1. Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Jun 26, 2009
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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