Carralero-Martínez et al. Trials (2021) 22:356 https://doi.org/10.1186/s13063-021-05321-6 STUDY PROTOCOL Open Access Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial A. Carralero-Martínez1,2, M. A. Muñoz Pérez3,4,5, R. Pané-Alemany1, L. Blanco-Ratto1,6, S. Kauffmann1,6,7 and I. Ramírez-García1,8,9,10* Abstract Background: Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. This study aims to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 kHz as an adjunct treatment to other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS. Methods: This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into a CRMRF activated group or a CRMRF deactivated group and receive physiotherapeutic techniques and pain education. The groups will undergo treatment for 10 consecutive weeks. At the beginning of the trial there will be an evaluation of pain intensity (using VAS), quality of life (using the SF-12), kinesiophobia (using the TSK-11), and catastrophism (using the PCS), as well as at the sixth and tenth sessions. Discussion: The results of this study will show that CRMRF benefits the treatment of patients with CPPS, together with physiotherapeutic techniques and pain education. These results could offer an alternative conservative treatment option for these patients. Trial registration: ClinicalTrials.gov NCT03797911. Registered on 8 January 2019. Keywords: Chronic pelvic pain syndrome, Musculoskeletal pain, Physical therapy, Therapeutic interventions, Capacitive resistive monopolar radiofrequency, Randomized controlled trial, Gynecology, Urology * Correspondence: inesrg@blanquerna.url.edu 1 Rehabilitación Abdomino-Pelviana (RAPbarcelona SL), Barcelona, Spain 8 Servicio de Fisioterapia, Instituto Médico Tecnológico SL, Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. 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Trials (2021) 22:356 Page 2 of 8 Background The specific aims are to evaluate the efficacy of the Chronic pelvic pain syndrome (CPPS) is defined as “pain CRMRF according to the intensity of pain, quality of life, of non-oncological cause, intermittent or constant, in kinesiophobia, and catastrophism of patients participat- the lower part of the abdomen or pelvis, in both men ing in the study. In addition, sociodemographic and clin- and women, lasting at least 6 months, and with negative ical data, adherence to treatment, and possible adverse consequences that can be cognitive, behavioral, sexual events during treatment will be recorded for both and emotional” [1, 2]. It is a multifactorial disorder ser- groups. ious enough to cause urinary and genital functional dis- ability and with high prevalence rates (5.7% to 26.6% of Design women and 2.2% to 9.7% of men) [3–8]. This manuscript describes a research protocol for a People with CPPS have much higher rates of psycho- triple-blind, randomized controlled clinical trial. Partici- logical distress. The prevalence of anxiety ranges be- pants will be equally (1:1) and randomly allocated into tween 39 and 73%, compared to 12% of the general either an activated capacitive resistive monopolar radio- population, while depression is seen in 26 to 52%, com- frequency group (intervention group, IG) or a deacti- pared to between 5 and 10% of the general population vated capacitive resistive monopolar radiofrequency [9–13]. These conditions, along with catastrophizing, are group (control group, CG). Both groups will receive pain associated with increased severity of chronic pain and education and physiotherapeutic techniques (myofascial reduced quality of life [4, 14–18]. therapy, trigger point therapy, and/or manual therapy). In addition, people with CPPS tend to have central Participants, the investigators performing the interven- and peripheral nervous system hypersensitivity, with dys- tion, and the statistical analyses will be blinded. functional pain modulation that tends to aggravate pain An analysis of the results will be carried out at 6 and [19–24]. 10 weeks of treatment. In physical therapy consultations, there are a variety of therapeutic options with sufficient evidence to guide Location physical therapy for patients with CPPS [25]. The most This trial will take place at RAPbarcelona, a pelvic floor widely used is myofascial therapy, although these pa- specialized physiotherapy center in Barcelona. tients should be treated using a multidisciplinary ap- proach including other therapies such as psychology, Participants medication, or surgery when other treatments have Patients receiving their first consultation at the center, failed [26, 27]. One such option in clinical practice is or those referred by other health professionals familiar capacitive resistive monopolar radiofrequency (CRMRF) with the protocol of this study, will be invited to at 448 kHz. This non-invasive strategy increases the participate. temperature of deep organs or tissues using radiofre- To be eligible, participants must meet the following in- quency electrical currents to reduce pain and inflamma- clusion criteria are of legal age, have suffered from CPPS tion and increase tissue repair [28–35]. Few recent for 6 months or more (etiologies will include myofascial studies evaluate its clinical efficacy despite being com- syndrome, endometriosis, adenomyosis, inflammatory mon practice for the last 20 years [36]. Current studies prostatitis, bladder pain syndrome, levator ani syndrome, report promising results in terms of pain reduction and pudendal nerve syndrome, or nonspecific CPPS), and improved function in musculoskeletal pathologies (such agree to participate in the study granting signed in- as low back pain) [37] and tendinopathies (such as plan- formed consent. Exclusion criteria include undergoing tar fasciitis) [38–40]. other conservative treatments during the study (manual Despite its demonstrated efficacy in other musculo- therapy, physical therapy, osteopathy, chiropractic, mas- skeletal pathologies, there is currently insufficient scien- sage), having undergone treatment with chemotherapy tific evidence regarding its role in the management of or radiotherapy in the pelvic area, having recently under- CPPS. gone an oncological process, being pregnant, having undergone surgery in the pelvic area in the last 3 months, presenting fibromyalgia or chronic fatigue, suf- Methods fering serious psyche disorders, presenting hypersensitiv- Aim ity in the skin that may be in contact with the treatment, The superiority study hypothesizes that the application or suffering from neuromuscular diseases. of CRMRF associated with physiotherapy techniques and health education provides benefits in reducing pain Procedure when compared to physiotherapy and health education Patients who agree to participate in the study will re- techniques alone in patients with CPPS. ceive CRMRF therapy for 30 min once a week. The first Carralero-Martínez et al. Trials (2021) 22:356 Page 3 of 8 session, lasting between 45 and 60 min, will serve to in- Both groups will follow the same protocol, which will form the patient, obtain signed informed consent, re- consist of applying the CRMRF (INDIBA Activ CT8®, solve any doubts about the study or questionnaires, and INDIBA S.A, Sant Quirze del Vallès, Barcelona, Spain) explain the theory of pain and health education. at 2% to induce an electrical and athermic effect, along At baseline, participants will undergo an initial assess- with pain education and physiotherapeutic techniques ment where data on age, medical history, surgical history, [43, 44] administered at the same time as the CRMRF and clinical data will be collected. According to criteria according to the location of the pain (Table 2). Partici- used in previous similar studies [41, 42] palpation of the pants will be placed comfortably in a supine or prone abdominal, lumbosacral, and perineal region will be per- position (depending on the area to be treated) with a pil- formed, followed by internal palpation using the index fin- low under their heads, undressed from the waist down. ger at the vaginal and/or anal level to palpate the pelvic The plate will be placed on the abdomen or lower back floor muscles, connective tissue, and internal organs, and depending on the patient’s position, and the 32 mm re- to localize pain. During the first visit, the visual analog sistive electrode will be used to apply the CRMRF to the scale (VAS) will be used to measure the intensity of pain, affected area. the health questionnaire Short Form 12 (SF-12) to assess Participants in the IG will receive treatment with the the quality of life, the Tampa Scale for Kinesiophobia activated CRMRF (emitting electrical signal) while par- (TSK-11) to assess kinesiophobia, and the Pain Catastro- ticipants in the CG will receive the same treatment with phizing Scale (PCS) to assess catastrophism. The same the deactivated CRMRF (not emitting electrical signal). tests will be re-evaluated after 6 and 10 sessions. Also, at This CRMRF equipment, specifically modified for re- each session, treatment adherence and possible adverse search purposes, is designed to perform both the con- events of the therapy will be identified and recorded in a ventional treatment (IG) and a placebo treatment (CG) database designed for the project. without any visible difference to either the therapist or The most common adverse reaction to the application the participant. The equipment, fully adapted for our re- of CRMRF, particularly at the beginning of treatment, is search, produces automatic randomization for each par- an increase in pain in the area lasting approximately 2 to ticipant according to the order of the study assignment. 3 days, which can be controlled with the local applica- Pain education will consist of basic theory about gate tion of heat and the use of oral analgesics. In rare cases, control [45], concepts of pain and central sensitization, due to the local application of heat, dermal irritation and a basic explanation of the neurotransmitters that in- could appear. In this case, topical treatments may be ap- fluence the increase or decrease in pain [46–48]. plied. If the dermal irritation persists in the next session The physiotherapeutic techniques that will be per- (after 1 week), it will be noted on the patient’s record formed in each session will be the same in all individual- sheet and the intervention will cease until it is com- ized treatment sessions for each patient and assigned pletely resolved. according to the location of the pain (Table 2). These A total of 10 treatment physiotherapy sessions will be techniques will be those recommended by the literature held weekly (Table 1). for the treatment of CPPS and will consist of myofascial Table 1 Treatment sessions Intervention group (IG) Control group (CG) Session 1 Review of the information sheet and signing of informed consent. Collection and recording of baseline data (age, sociodemographic data, clinical data, and medical and surgical history). Self-completion of tests (VAS, SF-12, TSK-11, and PCS). Application of physiotherapeutic techniques with activated CRMRF. Application of physiotherapeutic techniques with deactivated Explanation of the theory of pain and health education. CRMRF. Explanation of the theory of pain and health education. Session 2– Session protocol: Session protocol: 5 • Registration of possible discomfort or adverse events perceived • Registration of possible discomfort or adverse events perceived by the patient. by the patient. • Application of physiotherapeutic techniques with activated CRMR • Application of physiotherapeutic techniques with deactivated F. CRMRF. • Pain education clarifications • Pain education clarifications Session 6 Collection of VAS, SF-12, TSK-11, and PCS tests. Session protocol (as described in session 2–5) Session 7– Session protocol (as described in session 2–5) 9 Session 10 Session protocol (as described in session 2–5) Assessment of VAS, SF-12, TSK-11, PCS tests, evolution of the pathology, and referral (if required). Carralero-Martínez et al. Trials (2021) 22:356 Page 4 of 8 Table 2 Physiotherapeutic techniques and position of the patient during treatment sessions, depending on the location of the pain Anterior location Posterior location (abdomen, pubis, groin, perineum, vagina, penis, testicles) (lumbar, sacrum, coccyx, buttocks, anus, rectum) Position: Patient in supine position. CRMRF plate on lower back Patient in the prone position. CRMRF plate on abdomen Techniques: • Abdominal area: • Lumbosacral area: - Lift techniques of the peritoneum - Relaxation of the quadratus lumbar - Liberation of the urachus - Relaxation of the paravertebral muscles • Groin area: • Gluteal area: - Stretching the inguinal ligament - Decompression of the pudendal nerve in the greater sciatic foramen - Myotensive techniques of the internal obturator - Stretching of the sacrociatic ligament • Vulvar, perineal and vaginal area: - Stretching of the sacrotuberous ligament - Relaxation of the superficial fascia of the perineum - Release of the pudendal nerve in the ischiorectal fossa - Stretching the prevesical ligament - Myotensive techniques of the pyramidal - Uterine release techniques - Myotensive techniques of the external obturator - Stretching of the round ligament • Anorectal area: - Stretching of the wide ligament - Sacral plexus release techniques - Relaxation of the sacrorectogenitopubian laminae - Relaxation of the sacrorectogenitopubian laminae - Release of the pudendal nerve in Alcock’s canal - Stretching the Denonvilliers fascia • Penis and testicular area: - Prostate release techniques - Relaxation of the superficial fascia of the perineum - Relaxation of the deep fascia of the perineum - Testicular drainage If there is scarring, manual scar work is performed, and the 35 mm resistive electrode is applied over it. induction techniques, trigger point therapy, and manual Specifically, the Spanish adaptation of the SF-12 therapy with the aim of improving the elasticity of the Health Survey [52, 53] done by Alonso et al. [54, 55] musculature and fascial tissue and improving blood flow. will be used. The SF-12 is a reduced version of the They will be performed with smooth, slow, and increas- SF-36 Health Questionnaire designed for cases in ingly direct movements, beginning distally and becoming which a shorter questionnaire is required. While the more localized [49]. This information will be emphasized SF-12 can be answered in an average of ≤2 min, the to the patient to improve treatment and follow-up, as SF-36 takes between 5 and 10 min to complete. It well as the fact that this ordinarily costly treatment will consists of 12 items from the 8 dimensions of the have no cost for study participants. SF-36 (physical function, social function, physical As this is a study with multiple tests and interventions, role, emotional role, mental health, vitality, body several physical therapists will be needed to carry it out. pain, and general health status). A higher score For this reason, and to avoid errors due to lack of means better quality of life. standardization, there will be training in the application  The kinesiophobia: Fear of movement will be of the therapy and data collection for all physiotherapists measured by the Tampa Scale for Kinesiophobia who participate in the study. (TSK-11). This questionnaire, created by Miller et al. [56], quantifies the intensity of kinesiophobia Outcome measures suffered by the patient. The reduced version and Participants will complete three study assessments: a base- adaptation to Spanish by Gómez-Pérez et al. [57] line assessment and at 6 and 10 weeks after the first session. will be used. It consists of 11 statements that the Primary outcome: patient must answer using a Likert-type scale from 1 (totally disagree) to 4 (totally agree). A higher score  The intensity of pain: According to the VAS score, means a greater degree of kinesiophobia. which will be evaluated in the first, sixth, and tenth  The catastrophizing: Measured with the Pain sessions of the study. This quantitative and Catastrophizing Scale (PCS) [58]. This 13-item ques- subjective variable consists of marking the degree of tionnaire assesses the patient's catastrophic thoughts pain intensity in a straight horizontal line of a fixed using a five-point Likert scale. It consists of three length of 10 cm. The ends are defined as the subscales (rumination, magnification, and hopeless- extreme limits of the parameter to be measured ness). A higher score means a greater degree of cata- from left (worst) to right (best) [50, 51]. strophizing. The Spanish adaptation validated by García Campayo et al. [59] will be used. Secondary outcomes:  Sociodemographic variables, pathological history, and clinical history: Assessed in the first treatment  The quality of life related to health: Measured with session and collected through a standardized clinical the SF-12 Quality of Life health questionnaire. history. Carralero-Martínez et al. Trials (2021) 22:356 Page 5 of 8  Adverse events: Recorded in each of the treatment interested patients who meet the selection criteria, and sessions through patient references to his or her patients will be asked to sign an informed consent if they status and evolution. choose to participate. Patients will then be allocated to  Adherence to treatment: Assessed in each of the one of the two study groups. treatment sessions and collected through a compliance form designed for the project. Random allocation of groups Schedule Table 3 Once participants are included in the study, they will be identified by the number from their computerized Sample size medical record and will be ordered sequentially and To estimate the sample size, version 7.12 (April 2012) of consecutively from 1 to 80 according to the order of the sample size calculator of the “GRANMO” program recruitment. To assign interventions, CRMRF team was used. This version can be obtained at the following engineers will enter the randomized sequence corre- link: https://www.imim.es/ofertadeserveis/software- sponding to each number from 1 to 80 into the study public/granmo/. software to designate the CG and IG participants. In For this estimate, alpha values of 5% and beta values order to keep the assigned study group hidden from of 20% (power of 80%) were taken into account. Based the patient, the physiotherapist, and the main re- on data published in the literature [60] and applying a searcher, the following four indications will be taken common standard deviation of 3 and a difference equal into account: (1) No parameter will appear on the to or greater than 2 in the VAS, 40 patients are needed screen visible to the CRMRF team that indicates for each leg of the study, assuming a maximum percent- whether the equipment emits an electrical signal. (2) age of follow-up losses/dropouts of 10%. The current intensity parameter will be 2% for all participants to prevent the intervention group patients Selection of the sample from perceiving any thermal effect. (3) The physio- The selection of the sample will be done by sampling therapists will apply the CRMRF by manipulating the consecutive cases from the RAPbarcelona clinic in Bar- equipment with the handle and never with the elec- celona. Health professionals from other institutions will trode to avoid any sensation. They will be trained be- be contacted to increase referrals to the center and an fore starting the study. (4) The sequence of advertising campaign will be carried out on social net- randomization and allocation will be kept hidden at works. In physiotherapist appointments, patients with all times from all patients, professionals, and the main CPPS will be referred to the principal investigator. The researcher until the statistical analysis once the inter- protocol will be clearly explained to each of the vention is completed. Table 3 The different schedule phases are shown in italics Recruitment Session 1 Sessions 2–5 Session 6 Sessions 7–9 Session 10 Recruitment: Selection screening X Informed consent X Allocation X Interventions: Intervention CG (deactivated CRMRF X X X X X Intervention IG (activated CRMRF) X X X X X Evaluations: Demographic variables X Clinical variables X VAS X X X SF-12 X X X TSK-11 X X X PCS X X X Compliance form X X X X X Recording of adverse events X X X X X Carralero-Martínez et al. Trials (2021) 22:356 Page 6 of 8 Collection, management, and data analysis Abbreviations Data will be collected in a specific database coded for CG: Control group; CPPS: Chronic pelvic pain syndrome; CRMRF: Capacitive resistive monopolar radiofrequency; IG: Intervention group; PCS: Pain this study, which will only be available to the main re- Catastrophizing Scale; SF-12: Health Questionnaire Short Form 12; TSK- searcher. The database and statistical analysis will be 11: Tampa Scale for Kinesiophobia; VAS: Visual analog scale performed with IBM SPSS Statistics 24.0 software. First, a descriptive analysis of the characteristics of the Supplementary Information patients included in both study groups, as well as the The online version contains supplementary material available at https://doi. org/10.1186/s13063-021-05321-6. outcome variables will be carried out. To do this, abso- lute and relative frequencies (percentages) will be esti- Additional file 1. mated for qualitative variables, and mean or median and standard deviation or range, respectively, depending on Acknowledgements the normality of the distribution, for quantitative vari- We want to thank Mr. Sebastià Sendrós and his staff (INDIBA SAU, ES) who ables. Then, the comparative analysis of the two treat- have volunteered their technical support in helping us with the ment groups will be carried out using the Chi-square randomization of the equipment (INDIBA Activ CT8®) to be used for this study. Thank you to Dr. Emilia Sánchez and Ms. Helen Poliquin for their test for qualitative variables and the Student’s t test for support in reviewing this article. quantitative variables. Additionally, different associations between diverse variables will be analyzed. To check for Authors’ contributions ACM and IRG were responsible for the study concept and design. MAMP the efficacy of the study treatments, intention to treat collaboratively conceptualized the study objectives and methodology and (ITT) and by protocol (PP) analysis will be performed. provided a critical revision of the manuscript. RPA, SK, and LBR helped The comparison of results will be done by promptly conceptualize and design the study. All authors read and approved the final manuscript. The authors declare that INDIBA SAU (ES) has no role in study estimating the differences of the mean values of the out- design, data collection and analysis, decision to publish, or preparation of come variables with their corresponding 95% confidence the manuscript. intervals (95% CI) and standard deviation (SD). Add- Funding itionally, the adjusted differences will be calculated fol- No funding. lowing the indications of the CONSORT document [61]. All data will be systematically included in the statis- Availability of data and materials tical database and an analysis of the results will be car- Not applicable. ried out individually for each participant both in the Declarations middle of the treatment (fifth session) and at the end (tenth session) to evaluate the evolution. The trial will Ethics approval and consent to participate This protocol has been evaluated and approved by the Research Ethics cease if significant worsening, absolute improvement Committee of the Vall d’Hebron University Hospital (Comité de Ética de (VAS = 0), or unknown serious adverse events occur. A Investigación con Medicamentos y comisión de proyectos de investigación full preliminary results analysis will be performed when del Hospital Universitari Vall d’Hebron) (PR(RAP)361/2018). The development of the project is based on following and respecting the one-third of the sample size has been reached and the bioethical principles of beneficence, nonmaleficence, autonomy, justice, final analysis will be performed once the last participant dignity, and privacy, the Declaration of Human Rights, the Belmont Report, has completed the intervention. and the International Declaration on Bioethics and Human Rights of UNESCO. It is also grounded in the statements of the World Medical In all cases, the level of statistical significance estab- Association of Helsinki, the Deontological Code of the Association of Medical lished will be the usual (5%); therefore, statistically sig- Colleges of Spain, and the Deontological Code of Physiotherapists of nificant differences will be considered when p values are Catalonia and Spain. All patients will be informed verbally and via an information sheet and will less than 0.05. be required to sign the informed consent. Participation in the study may be interrupted by the patient at any time if desired, and without negative consequences for the individual. Discussion All data collected will be confidential, respecting the Spanish data protection The results of this study will make it possible to prove law (LOPD Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales). Likewise, the privacy of each that CRMRF benefits the treatment of patients with participant will be respected at all times. Only the principal investigator, the CPPS together with physiotherapeutic techniques and physiotherapists who perform the interventions, and the statistical analyst pain education. These results could offer an alternative will have access to the final data set. This clinical trial will be registered at ClinicalTrials.gov and data will be conservative treatment option for these patients. updated systematically, as well as any changes to the protocol. The aim is to publish the results in the form of a doctoral thesis by the principal investigator. Trial status This is the first version of the protocol (January 28, Consent for publication Not applicable. 2021). Recruitment began in April 2019 and the inter- vention was put on hold due to the coronavirus crisis. Competing interests For this reason, completion is expected by next April. 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