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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00928564
Enrollment
40
Registered
2009-06-26
Start date
2009-04-30
Completion date
2016-05-31
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Muscle Spasm

Keywords

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

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.

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.

Interventions

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.

DRUGPlacebo

5ml of saline at each block site.

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Pain Score After 6 Weekly Injectionsup to 8 weeks10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain

Secondary

MeasureTime frameDescription
Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnairesup to 6 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
28
Placebo
5ml of saline at each block site Placebo: 5ml of saline at each block site.
12
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up60

Baseline characteristics

CharacteristicPlaceboTotalPudendal Block
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants40 Participants28 Participants
Age, Continuous45 years
STANDARD_DEVIATION 4
46 years
STANDARD_DEVIATION 3
46 years
STANDARD_DEVIATION 3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
10 Participants33 Participants23 Participants
Region of Enrollment
United States
12 participants40 participants28 participants
Sex: Female, Male
Female
12 Participants40 Participants28 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
4 / 224 / 12
serious
Total, serious adverse events
0 / 220 / 12

Outcome results

Primary

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

Time frame: up to 8 weeks

ArmMeasureValue (MEAN)Dispersion
Pudendal BlockVisual Analog Pain Score After 6 Weekly Injections3.33 Visual Analog Pain ScoreStandard Deviation 1.87
PlaceboVisual Analog Pain Score After 6 Weekly Injections2.99 Visual Analog Pain ScoreStandard Deviation 2.03
Secondary

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.

Time frame: up to 6 months

ArmMeasureValue (MEAN)Dispersion
Pudendal BlockImprovement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires47.2 score on a scaleStandard Deviation 30.8
PlaceboImprovement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires38.2 score on a scaleStandard Deviation 29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026