A Pilot Randomized Trial of Levator Injections Versus Physical Therapy for Treatment of Pelvic Floor Myalgia and Sexual Pain. Issue 9 (September 2015) - Zoorob, Dani
Abstract ABSTRACT Female chronic pelvic pain affects about 1 in 7 women in the United States. The condition is not due to a singular cause but is associated with a myriad of disorders and in many cases is undiagnosed. Pelvic floor myalgia (PFM), also known as levator myalgia, refers to a subtype of chronic pelvic pain that is due to pelvic myofascial dysfunction associated with chronic vaginal tenderness and dyspareunia, and that prevents these women from engaging in normal vaginal sexual activity. Trigger points are present that are distinct hyperirritable areas of pain loci in taut bands of vaginal muscle. A large number of therapies have been widely used for PFM despite lack of adequate comparative level 1 evidence or set management algorithms. Among these therapies, pelvic floor physical therapy (PT) has been reported to reduce chronic pain and facilitate sexual comfort by relieving levator muscle spasticity. Physical therapy involves vaginal muscle massage. Levator ani muscle trigger-point injections (LTPIs) are an alternative or a complementary treatment for PFM. Mixtures of local anesthetics and steroids have been used for LTPIs. It has been hypothesized that PT and LPTI are equivalent and that either approach can be offered as initial treatment. The aim of this randomized comparative trial was to determine the effects of PT and LTPIs on sexual function and levator-related pelvic pain in women with PFM. Patients treated with LTPIs were injected intravaginally with a solution containing triamcinolone and a local anesthetic mixture of lidocaine and bupivacaine. Patients treated with PT were started on a regimen of pelvic floor massage. Levator-based pain was evaluated using a validated numeric rating scale (NRS) and the Patient Global Impression of Improvement (PGI-I) scale. The Female Sexual Function Index (FSFI) was used to assess sexual function. The primary study outcome was the relative change in PFM between LTPIs and PT before and after treatment. Secondary outcomes were the mean changes in the PGI-I and FSFI. Of the 34 women enrolled and randomized, 29 initiated therapy and completed the study (17 had PT, 12 had LTPIs). Overall vaginal pain based on NRS was reduced in both treatment groups, but the mean change in NRS from baseline was not significantly different between groups: 4.47 (SD, 2.12) for PT and 4.67 (SD, 1.72) for LTPIs (P = 0.8). A greater than 50% improvement in NRS occurred among 59% of women receiving PT and 58% of those receiving LTPIs (P = 1.0). Similarly, there was no significant difference between groups in mean PGI-I scores: 2.50 (SD, 1.17) for PT versus 2.17 (SD, 1.01) for LTPIs (P = 0.45). With respect to sexual function, however, mean change in FSFI favored PT (PT: +8.87 [SD, 5.60] vs LTPIs: +4.00 [SD, 5.24]), P = 0.04): this reflected improvement in the sexual pain domain favoring PT (P = 0.02). The time in weeks to achieve improvement favored LTPIs (4 weeks of LTPIs vs 7 weeks of PT) when controlling for the degree of change in NRS (P = 0.01) and FSFI (P = 0.01). This pilot study shows that vaginal myalgia and sex-related pain improved with both pelvic floor PT and LTPIs. The overall improvement was higher in the PT group, whereas improvement was faster in the LTPI group.