Strengths and limitations

Strengths: 1. A pioneer randomized controlled study performed by a single operator with strict implementation of the exact same PFFM method. 2. The high correlation between the subjective measurements via perineometer and the objective measurement of pelvic strength via Oxford grading scale in both groups validate our results. Limitations: 1. A small sample size and due to moderate compliance only 26 out of 40 participants completed the study. 2. The assessment of the majority of patients in both groups was done by the main researcher, which can affect the objectivity of the measurements. However, each measurement was performed independently and separately while the analysis and the comparison of the results was only done at the end of the study. Moreover, the results of the measurements performed by the researcher agree with PFDI-20 questionnaire results filled by the participants. We had positive effect for the PFFM, and our results, where manual therapy is shown to improve muscle and joint function are in agreement with the existing data in the literature57. 3. There was a basal difference in the strength of the pelvic floor between the treatment and the control group which made the comparison cumbersome. However, most of our tests applied an intra group benefit for the treatment method.
N. S.-Planning, carrying out, analyzing and writing
M.S.A-Planning, carrying out
C.E- Planning, analyzing
H.I- Planning, carrying out, analyzing and writing
The study was approved by the IRB of the Sheba Medical Center, (3722-16-SMC) on February 14th 2017. NIH registry. (approval no. NCT03041246). Full trial protocol is available at the NIH registry.First Posted: February 2, 2017, First enrollment: January 1, 2018
No funding was granted for this trial
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