A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain

Zoorob, D. et al,

Int Urogynecol J (2015) 26:845-852. 

Question investigated: Are PT and Levator Trigger point Injections (LTPI comparable as treatment for improving chronic pain and sexual function (PFM Pelvic floor myalgia )?

Materials and methods: ramdomized trial btw a course of vaginal injections of triamcinolone and bupivacaine vs. pelvic floor PT for treatment of PFM.

Patients: chosen by 1 of 2 MDs, with self-reported pelvic pain and evidence of MTPs in pelvic floor ( PR, PC, IC, C and OI). No prior pelvic rehab or LTPI .Randomized to either group.

Aged 18+, sexually active, pain with intercourse, Excluded if: pregnant, used aspirin within a week of study, hx untreated pelvic absess, cardiac arrhythmia,  bladder pain syndrome, current pelvic rehab or LTPI.

2 groups: LPTI by doc.  Or PT from pelvic floor PT. Weekly rx,

LTPI: lithotomy position, injected with steroid and local anesthetic . min of 5 ml solution injected up to 4 sites, per pt. ( 2 sites per side.)Iowa trumpet , tip into ms 1-2 cm. ½ administered, then moved to other TP, ( med = triamcinolone 40mg, anaesthetic 2% lidocaine, and .25% bupivacaine. Mixture was 1 ml of triam (40mg/ml) plus 9ml of bupivacaine 0.5%) 

PT: MF TP release using pelvic massages, 60 min sessions, intravaginal stretches and compression maneuvers.

Outcomes:

NRS-P numeric rating scale (better than VAS to indicate a change of >50%) in chronic pain. Lower number to higher, 10 = worst pain. Done prior to exam or manip.

PGI-I (pt global impression of improvement survey) (7 point scales, lower  is more favorable outcome, 1 question each)

FSFI : 19 six point q’s, six domains, min score is 2, max is 36. Higher scare = better sexual function.

Pt inclusion: 1 TPI or 3 PT sessions, up to 6 LTPI or 10 PT sessions were allowed until pt reported improvement or max reached. No pain relievers allowed orally.

NRS and PGI given weekly. One month after completing study, ( aver 10 weeks after starting study, NRS, PGI and FSFI re administered. )

Results: 47 pts approached, 13 excluded, 34 pts enrolled. 17 pts per group. All 17in PT group stayed and got treated, 5 dropped out of LTPI due to their allocation. 29 completed study.

Categories:

Pelvic floor myalgia: NRS no signif difference for number of treatments. Per treatment, NRS favored LTPI.

Sexual function: both groups improved. Most seen with PT. (8.87 vs 4 for LTPI. )

Controlling for # sessions: neither group favored. FSFI. Only sexual pain domain signif improved. (2.40 for PT and .8 for LPTI.

Sexual dysfunction: decreased 4 fold in PT group. Resolution of 35% in PT group vs. 75 in LTPI.

 Global improvement:  no difference. Report of No improvement: 1 in PT, 2 in LTPI.

Discussion:
Both treatments reduced chronic PP and improved sexual dysfunction. PT assoc. with overall greater improvement. (in sexual pain of FSFI)

LTPI requires less session time than PT. Hence, it is better than PT when effect of treatment time is analyzed. (Author suggested revealing this to patients when counselling them on rx. )

NO study documents one mixture of meds over another. LTPI not understood.

Either treatment only improved scores in only 7 pts in the dysfunction domain.

PT 7 weeks to improvement vs. LTPI was 4 weeks. As # sessions increased, the signif improvements decreased. In LTPI vs. PT.

Limitations: small sample size, No one blinded to rx allocation, and intention to treat analysis not implemented. Short term follow up. Can’t report duration of improvement in vaginal pain or sexual function.

Conclusion: vaginal and sexual pain can be improved by either PT of LTPI. Improvement faster in LTPI, but amount of improvement better with PT.

Thoughts?

Has anyone experienced amount of improvement decreased with increased # sessions with PT?

Anyone suggest dual therapies for their pts, namely stagnated or failed PT trial?