Title: Therapeutic ultrasound versus injection of local anesthetic in the treatment of women with
chronic pelvic pain secondary to abdominal myofascial syndrome: a randomized clinical trial.
Version: 3 Date: 13 Mar 2022
Reviewer's report:
Dear authors,
Thanks for your study with these women suffering from CPP and having limited quality of life
due to the chronic pain. It is necessary that we find treatment approaches being effective and
suitable for the women. Thus, your research could contribute in this strive for optimal care for
women with CPP. However, your manuscript needs some revision.
Background:
- The reasoning for the study should follow a red line: How are the 30% of women with CPP
and AMP affected from AMP? What are their symptoms? Does it affect their activities of daily
living or their quality of life? How were the women usually treated? Why is this treatment
not sufficient making new approaches like this study necessary? What research gap should be
closed? In return, the paragraphs about the etiology of triggerpoints, anesthetic injection, and
TUS can be shortened.
- P 3: Please revise first sentence; there seems to miss a word at the end or the order of words
is incorrect.
Material and Methods:
- Study design: The date of registration cannot be possible with a month “18”? Is the order of
month/day/year correct? Please also check if you have used the date format consistent throughout
the manuscript.
- Inclusion criteria: Please provide upper age limit for inclusion.
- Exclusion criteria: Are pregnant women only excluded when they have hip prosthesis or are
pregnancy and hip prosthesis two separate exclusion criteria? The sentence is confusing, please
revise. Also revise the last sentence in the exclusion criteria section.
- Why did you have to perform the assessment for the presence of an abdominal trigger point
after inclusion and randomization when the presence of such a trigger point is an inclusion
criterion? Thus, it should have been already determined otherwise the woman would not have
been eligible…
- Interventions: Why did the TUS group receive 10 treatment sessions and the IA group 4
treatment sessions?
- Why did you choose these two treatment approaches especially and no placebo group or waiting
list/no treatment?
Results:
- Please provide information how many women have been screened for eligibility, how many
were not eligible, refused to participate…
- Please revise the first very, very long sentence of your result section.
- Your flow chart is quite unusual and not that easy to read, please consider another way of
presenting the flow of patients and provide a legend what is group A and what is group B.
- What were the reasons of women to withdraw with relation to the treatment? What were the
other reasons to withdraw not related to the treatment?
- Table 1: Please provide the units of measurement for the different variables where appropriate.
Please change “normal birth” to “vaginal delivery”.
- Why did you only report the location of the MTrP in terms of right and left but not the
anatomical location naming the muscles?
- Why did you present the measurement results of SF-36 and McGill in tables with numbers and
p-values for the between group measurements and the results of VAS and NCS only graphically?
- Your first statement on page 14 is firstly confusing as it stated that TUS with IA seemed to
be effective rather than TUS or IA and could secondly not easily be followed because you did
not provide p-values for the intragroup comparisons for SF-36 and McGill and no numbers or
values for VAS and NCS at all.
- What was the reasoning for measuring pain during treatment sessions?
Discussion:
- Please start your discussion with a brief summary of your work (one short paragraph).
- Please provide references for the third paragraph in the interpretation of the results section for
the statement that the placebo effect exists.
- Why is the occurrence of no changes in the final reevaluations compared to the initial
reevaluations a cue that the influencing effects were minimized?
- Please discuss the influence of different locations of trigger points in the different abdominal
muscles. Did the location of the trigger point influence your results?
- Please discuss why you have not reached your planned sample size according to your proposal
of 30 women in each group.
- Please discuss your loss to follow up.
- Limitations: Why did you not choose a waiting list for the control, which could ease your
ethical implications? Why did you choose the different treatment durations in TUS and IA when
you knew it is a limitation?
Overall:
- Please provide more recent references for your statements where possible. For example, the
literature stating that up to 85% of patients with CPP have musculoskeletal disorders is from
1984, 1993 and 2003.
- Please revise your manuscript with regard to English language; there are some unusual phrases
and long sentences.
- Please revise your references carefully, e.g. reference no. 10 has a wrong title.
- Please revise your abstract according to the changes in the manuscript.