Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.
Phase: NA
Conditions: Pain, Dysfunction Sexual
Sponsor: University of Valencia

Conservative approach to dysfunctional pain in women 
V.01 (01-12-2021) 
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RESEARCH PROTOCOL 
 
Study identification data 
 
Study Title 
 
Conservative approach to dysfunctional pain in women 
 
Study version number and date 
 
V.01 (01-12-2021) 
 
Promoter and direction 
 
Borja Perez Dominguez. C/Valencia, 17. Low. Gillet (Valencia). 46149 
 
Principal Investigator and Director 
 
Borja Perez Dominguez. C/Valencia, 17. Low. Gillet (Valencia). 46149 
 
Service or Unit 
 
Gynecology/Rehabilitation 
 
Centers where the study is planned (multicenter studies) 
 
Hospitals of Sagunto, La Plana, IMSKE Valencia and University of Valencia 
 
Study Summary 
 
Study that will seek to compare the effects of the implementation of a therapeutic 
education program in women suffering from dyspareunia for a period of more than three 
months who do not have any previous medical condition that can logically explain this 
condition. The effects of three groups will be compared; one that attends face-to-face 
workshops, another that will receive access to a website where the educational content 
will be, and a third that will serve as control. 
 
Study Introduction 
 
This research project is entitled "Conservative approach to the patient with dysfunctional 
pain in the pelvic floor in women". It will be carried out both by researchers from the 
University of Valencia and by external researchers from other hospitals. 
 

Conservative approach to dysfunctional pain in women 
V.01 (01-12-2021) 
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We understand dysfunctional pain as pain that stops fulfilling the function of "alarm 
signal" and that stops responding to a nociceptive stimulus (1). This alarm signal can be 
triggered by previous pathologies, such as endometriosis (2) or musculoskeletal 
conditions such as muscle hypertonia (3) or neuralgia (4). 
 
Despite this, this pain can also originate without the existence of any of the previous 
conditions, therefore without having a clear origin that can be addressed through 
treatment. In the pelvic floor, this dysfunctional pain can come to take different names, 
among which we highlight "dyspareunia" and "vestibulodynia" (5). 
 
“Dyspareunia” is a term derived from the Greek that means lovers who do not fit together 
(6), and it is a sexual disorder that is defined by the presence of pain and discomfort 
during the sexual act, in addition to being predominantly associated with the attempt or 
achievement of sexual intercourse. complete vaginal penetration (7). Prevalence levels 
range from 3% to 43%, and vary depending on different cultures and settings (6) (8). 
 
Study justification 
 
The lack of a good educational level in women's health disorders can lead to 
misinterpretations about normality, and these end up causing both sexual and emotional 
repercussions (8). It is a common misconception that intercourse can sometimes be 
painful, and many women are forced to continue intercourse even in pain, even having to 
clench their teeth. 
 
Because of this, women who suffer from dysfunctional pelvic floor pain develop 
clinically relevant comorbidities, especially psychological ones, such as depression, 
anxiety or erotophobia (6) (8) . 
 
 
 

Conservative approach to dysfunctional pain in women 
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For this reason, the treatment of dysfunctional pain with therapeutic educational sessions 
is proposed so that women who suffer from dyspareunia are able to better understand the 
processes of this condition and, possibly, solve it. 
 
Study Objectives 
 
The main objective of this study is to compare the effects of implementing a therapeutic 
educational program on pelvic floor pain and dysfunction in patients with dysfunctional 
pain. This program will be administered both in person at workshops organized in 
different centers, and online through a web platform. 
 
As a secondary objective, the adherence levels of each of the proposed educational 
programs will be analyzed. 
 
Material and methods 
Design 
 
Randomized controlled clinical trial. 
 
Disease o Study population and total number of subjects 
 
Women with dysfunctional pelvic floor pain that cannot be explained by another 
underlying medical cause 
 
Selection criteria (inclusion and exclusion) 
 
Women who (1) are of legal age, (2) have suffered from dyspareunia for more than 3 
months and (3) do not have any medical condition that logically explains the presence 
of pain 
 
Main variables 
 
Level or intensity of pain, evaluated using subjective perception scales (Visual 
Analogue Scale or VAS). 
 
 
 

Conservative approach to dysfunctional pain in women 
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Secondary variables 
 
Other questionnaires related to dysfunctional pain; Pain Catastrophizing Scale to 
quantify the patient's individual experience of pain, the Multidimensional Pain 
Inventory to measure the impact of pain on the patient's life, the Survey of Pain 
Attitudes related to the patient's beliefs about pain, and the Female Sexual Function 
Index related to the patient's sexual function. 
 
The levels of adherence to the different programs will also be evaluated, established 
by the percentage of sessions completed based on the total number of sessions offered. 
 
Interventions/procedures to be performed 
 
Initial phase of patient recruitment from various hospital centers and by broadcasting 
with an informative video on RRSS through the official profiles on Instagram, 
Facebook and Twitter of the University of Valencia and the Illustrious College of 
Physiotherapists of the Valencian Community. The hospital centers that will initially 
be considered for obtaining the sample are the La Plana and Sagunto Hospitals and 
the IMSKE Hospital in Valencia. After this first phase, and using the established 
inclusion and exclusion criteria, randomization of all the participants into three 
different groups. The randomization method will be a simple randomization 
performed through computer software. 
 
One group (1) will receive a therapeutic education program on pelvic floor pain and 
dysfunction in person as workshops held at collaborating centers, a second group (2) 
will receive access to a web platform where they can view as online content this same 
educational program and a third group (3) that will serve as control. 
 
 
 

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Both group (1) and group (2) will receive the same educational content, the only thing 
that will change is the modality in which they can access it, face-to-face through 
workshops given by specialist trainers, or access to an online platform where the 
contents previously recorded by these same trainers will be. 
 
a "forum" will be opened on the same website where they can comment on their 
doubts). Each workshop will last approximately one hour, and the schedule will be 
established according to the possibilities of the participants. 
 
The web platform will be developed thanks to a researcher who already has an online 
studio 
where 
she 
teaches 
therapeutic 
exercise 
classes, 
available 
athttps://mariaplazacarrasco.com. Participants who have been randomized in the 
online group will be given an access code to be able to enter the online space where 
they will have both the audiovisual material that has been previously developed by 
the researchers and a forum where they can discuss their doubts. 
 
Regarding the control group, initially the participants of this group will not receive 
any of the two previous interventions, this group will serve to establish how the 
condition is maintained without a therapeutic approach. Once the intervention has 
finished and the post measurements have been collected, the participants of this group 
will also be given access to the online study so that they can view the contents and 
comment through the forum. 
 
Work calendar 
 
Calendar 
Exercise 
Place 
Responsible 
October to 
December 2021 
Subject Selection 
H. La Plana, H. 
IMSKE, H. 
Sagunto, 
University of 
Valencia 
Jose Casaña 
Granell, Borja 
Pérez 
Domínguez, Aida 
López Brull 
December 2021 
to January 2022 
Measurements 
prior to the start 
H. La Plana, H. 
IMSKE, H. 
Sagunto, 
Aida Lopez Brull, 
Cristina Blasco 

Conservative approach to dysfunctional pain in women 
V.01 (01-12-2021) 
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of the 
intervention 
University of 
Valencia 
Ortiz, Marta 
Morales Baixauli 
January to March 
2022 
Intervention. 
Educational 
sessions on 
dysfunctional 
pain 
H. La Plana, H. 
IMSKE, H. 
Sagunto, 
University of 
Valencia and 
online modality 
 
Aida Lopez Brull, 
Cristina Blasco 
Ortiz, Marta 
Morales Baixauli 
March to April 
2022 
Post-intervention 
measurements 
H. La Plana, H. 
IMSKE, H. 
Sagunto, 
University of 
Valencia and 
online modality 
Aida Lopez Brull, 
Cristina Blasco 
Ortiz, Marta 
Morales Baixauli 
April 2022 
Preparation of a 
scientific article 
with the results 
obtained from the 
research 
 
Aida Lopez Brull 
 
 
Statistical analysis of data: equal to or less than 0.05) 
 
The study design aims to collect pre and post measurements with various 
interventions. To do this, since these are pre and post measurements with several 
groups, a factorial ANOVA will be carried out, a repeated measurement factor (time) 
and a factor between groups (intervention). 
 
The changes that are intended to be achieved are, with respect to the main variable, a 
significant reduction in the values of the VAS scale that corresponds to an 
improvement in terms of pain intensity. Regarding the secondary variables, 
significant changes in the score of the questionnaires on dysfunctional pain and sexual 
function that indicate clinical improvements regarding the impact of pain on the life 

Conservative approach to dysfunctional pain in women 
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of the participant and the beliefs about the pain of the same, and on the levels of 
adherence, find high values to be able to relate the results obtained with the 
implementation of the program. 
 
Sample size calculation and sampling procedure 
 
The sample size was determined using the G-Power computer program. An a priori 
size calculation was performed with an effect power of 80% and an alpha error of 
0.05. It was determined that the sample must have a minimum of 48 participants, and 
that each group must have a minimum of 16. Taking into account possible drop-outs, 
it was determined that a minimum sample of 60 participants and 20 participants for 
each group. 
 
Ethical aspects and data confidentiality 
 
This research deals with the implementation of an educational program on dysfunctional 
pelvic floor pain in women. It does not involve an invasive or aggressive intervention that 
could cause negative effects on the participants. In addition, if the final result is positive, 
there will be a tool that is easy to implement daily for the treatment of patients with this 
problem. 
 
 
 

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The subjects will be informed at all times of how the research will proceed, and before 
being included in the study sample they will be required to give their consent, both verbal 
and written, to participate in this research. 
 
We will ensure that the data provided by patients is strictly confidential. Patients will be 
coded to ensure their anonymity and both the principal investigator and the person in 
charge of processing the statistical data will be blinded to the group assignment and to 
which patient corresponds to which value. 
 
During the development of the investigation there will be no interference with regard to 
medical action. Once the study is over, and if the result is positive, the medical staff will 
be provided with the material with which the research has been carried out so that they 
can use it in their daily practice. 
 
Sources of funding 
 
The study has sufficient material and human resources to carry it out. Two researchers 
will coordinate its development, and the rest of the researchers will be in charge of 
carrying out the measurements prior to the start of the intervention, implementing the 
educational program and finally performing the measurements again. No medication will 
be supplied and there is no need for funding to carry out this research. 
 
Bibliography 
 
1. Nijs J, Van Houdenhove B. From acute musculoskeletal pain to chronic 
widespread pain and fibromyalgia: Application of pain neurophysiology in 
manual therapy practice. Manual Therapy. 2009;14(1):3-12. 
2. Delanerolle G, Ramakrishnan R, Hapangama D, Zeng Y, Shetty A, Elneil S, 
Chong S, Hirsch M, Oyewole M, Phiri P, Elliot K, Kothari T, Rogers B, Sandle 
N, Haque N, Pluchino N, Silem M , O'Hara R, Hull ML, Majumder K, Shi JQ, 
Raymont V. A systematic review and meta-analysis of the Endometriosis and 
Mental-Health Sequelae; The ELEMI Project. Women's Health (London). 2021 
Jan-Dec;17:17455065211019717. DOI: 10.1177/17455065211019717. PMID: 
34053382; PMCID: PMC8182632. 

Conservative approach to dysfunctional pain in women 
V.01 (01-12-2021) 
9
3. van Reijn-Baggen DA, Han-Geurts IJM, Voorham-van der Zalm PJ, Pelger RCM, 
Hagenaars-van Miert CHAC, Laan ETM. Pelvic Floor Physical Therapy for 
Pelvic Floor Hypertonicity: A Systematic Review of Treatment Efficacy. Sex 
Med 
Rev. 
2021 
Jun 
11:S2050-0521(21)00012-3. 
DOI: 
10.1016/j.sxmr.2021.03.002. Epub ahead of print. PMID: 34127429. 
4. Aoun F, Alkassis M, Tayeh GA, Chebel JA, Semaan A, Sarkis J, Mansour R, 
Mjaess G, Albisinni S, Absil F, Bollens R, Roumeguère T. Sexual dysfunction 
due to pudendal neuralgia: a systematic review. Transl Androl Urol. 2021 
Jun;10(6):2500-2511. DOI: 10.21037/tau-21-13. PMID: 34295736; PMCID: 
PMC8261452. 
5. Fučík Tomáš, Mašata Jaromír. Pelvic neuropathic pain (differential diagnosis). 
Ceska Gynekol. 2021;86(4):279-283. English. DOI: 10.48095/cccg2021279. 
PMID: 34493054. 
6. MacNeill C. Dyspareunia.Obstet Gynecol Clin North Am. 2006 Dec;33(4):565-
77, viii. DOI: 10.1016/j.ogc.2006.09.003. 
7. Rogers RG, Pauls RN, Thakar R, Morin M, Kuhn A, Petri E, et al. An international 
Urogynecological Association (IUGA)/international continence society (ICS) 
joint report on the terminology for the assessment of sexual health of women with 
pelvic floor dysfunction. Int Urogynecol J. 2018;29(5):647–66 DOI: 
10.1002/nau.23508. 
8. Weijmar Schultz W, Basson R, Binik Y, Eschenbach D, Wesselmann U, Van 
Lankveld J. Women's sexual pain and its management.J Sex Med. 2005 
May;2(3):301-16. DOI: 10.1111/j.1743-6109.2005.20347.x.