Pelvic PainNCT03797911
Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT
A study testing Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education and Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education in people with Pelvic Pain and Pelvic Pain Syndrome, run by RAPbarcelona at 1 site in Spain.
Trial summary
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Pain, Pelvic Pain Syndrome, Chronic Pain
- What is being tested?
- Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education and Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2019to 23 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an age equal to or greater than 18 years
- Having chronic pelvic pain of six or more months of evolution.
Who cannot join
- Failure to grant informed consent.
- Have fibromyalgia.
- Present a pacemaker or other type of electronic implant.
- Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
- Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
- Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy).
Show all 17Show fewer
- Have myelopathy and osteomyelitis.
- Have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia ...
- Have an alteration of the central nervous system (traumatic or spinal vascular injury)
- Suffer oncological processes with sacral involvement.
- Have a severe mental disorder.
- Have vulvodynia
- Be pregnant.
- Have undergone surgery in the last 3 months in the pelvic area.
- Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact.
- Inability to correctly complete the questionnaires or understand the study protocol.
- Having initiated other pelvic physiotherapy treatments during the study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
Read the detailed description
It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.
- Conditions
- Pelvic Pain, Pelvic Pain Syndrome, Chronic Pain, Chronic Pain Syndrome, Chronic Pelvic Inflammatory Disease, Physical Therapy
- Being tested
- Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education, Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
- Medical subject headings
- Pelvic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationCombination product
Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationCombination product
Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
| Study group | Role | What they receive |
|---|---|---|
| active resistive capacitive monopolar radiofrequency | Experimental | Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. Receives: Combination Product: Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education |
| Inactive resistive capacitive monopolar radiofrequency | Placebo comparator | Application of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. Receives: Combination Product: Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention.
The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain".
The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.
Measured: baseline and 10 weeks
Secondary outcomes (6)
Assess quality of life
Asess the perceived quality of life of patients in the study according to the SF-12 questionnaire.
The Short-Form 12 Health Survey was designed in 1994 with the aim that, through the self-completion of a brief questionnaire, the perception of physical and mental quality of life could be objectified in a simpler way than the original questionnaire SF -36. This simple questionnaire of 12 items representing the 8 dimensions of health was originally developed in English. It is a questionnaire that has proven to be valid and reliable to be used in clinical practice as an instrument to assess the quality of life. The 8 dimensions are the physical function (2 items), physical role (2 items), body pain (1 item), general health (1 item), vitality (1 item), social function (1 item), emotional role (2) items) and mental health (2 items). The result is two variables (physical and mental) that value quality in these two aspects.
Measured: baseline, 5 and 10 weeks
Assess kinesiophobia
Asess the kinesiophobia suffered by patients in the study according to the TSK-11 (Tampa Scale of Kinesiophobia) questionnaire.
The Tampa Scale of Kinesiophobia (TSK-11), validated in Spanish, adequately captures the patient's movement capacity taking into account the perceived pain intensity in 11 questions. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment.
Measured: baseline, 5 and 10 weeks
Assess catastrophism
Asess the catastrophism suffered by patients in the study according to the Catastrophism scale.
The Catastrophism Scale, also validated in Spanish, allows us to assess the catastrophic intensity of the disease, a more psychological aspect, but also very relevant in this chronic and disabling pathology. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. It is a questionnaire of 20 questions.
Measured: baseline, 5 and 10 weeks
Assess the degree of adherence to treatment
Assess the degree of adherence to treatment (%) of the patients who are in this study.
Measured: 10 weeks
Assess number of participants with high adherence to treatment
Assess the number of patients (n) with high adherence who are in this study.
Measured: 10 weeks
Assess number of participants with adverse effects
Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start23 Mar 2019
- Primary completion16 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPbarcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Carralero Martínez, RAPbarcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797911
- Sponsor's protocol ID
- RAP39426977
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2018
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carralero-Martinez A, Naranjo-Ortiz C, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Assessing Kinesiophobia and Catastrophizing Patient-Reported Outcomes in a Randomized Controlled Trial: Efficacy of Capacitive-Resistive Monopolar Radiofrequency Combined with Myofascial Techniques vs. Sham Radiofrequency in Chronic Pelvic Pain Syndrome-A Secondary Analysis. Int Urogynecol J. 2025 Apr;36(4):799-811. doi: 10.1007/s00192-025-06052-x. Epub 2025 Jan 28.
PubMed 39873778Carralero-Martinez A, Munoz Perez MA, Pane-Alemany R, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2021 May 20;22(1):356. doi: 10.1186/s13063-021-05321-6.
PubMed 34016168
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03797911
- Acronym / sponsor ID
- RAP39426977
- Conditions
- Pelvic Pain, Pelvic Pain Syndrome, Chronic Pain, Chronic Pain Syndrome, Chronic Pelvic Inflammatory Disease, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- RAPbarcelonaUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
Detailed description
It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active resistive capacitive monopolar radiofrequency | Experimental | Combination Product: Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationApplication of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education. The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. |
| Inactive resistive capacitive monopolar radiofrequency | Placebo comparator | Combination Product: Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationApplication of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education. The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have an age equal to or greater than 18 years
- Having chronic pelvic pain of six or more months of evolution.
Key exclusion criteria (17 listed)
- Failure to grant informed consent.
- Have fibromyalgia.
- Present a pacemaker or other type of electronic implant.
- Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
- Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationActivated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education. | Combination product | active resistive capacitive monopolar radiofrequency |
| Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain educationDisactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education. | Combination product | Inactive resistive capacitive monopolar radiofrequency |
Primary outcome
Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
Time frame: baseline and 10 weeks
The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention. The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain". The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.
6 secondary outcomes
Assess quality of life
Time frame: baseline, 5 and 10 weeks
Assess kinesiophobia
Time frame: baseline, 5 and 10 weeks
Assess catastrophism
Time frame: baseline, 5 and 10 weeks
Assess the degree of adherence to treatment
Time frame: 10 weeks
Assess number of participants with high adherence to treatment
Time frame: 10 weeks
Assess number of participants with adverse effects
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 39873778Carralero-Martinez A, Naranjo-Ortiz C, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Assessing Kinesiophobia and Catastrophizing Patient-Reported Outcomes in a Randomized Controlled Trial: Efficacy of Capacitive-Resistive Monopolar Radiofrequency Combined with Myofascial Techniques vs. Sham Radiofrequency in Chronic Pelvic Pain Syndrome-A Secondary Analysis. Int Urogynecol J. 2025 Apr;36(4):799-811. doi: 10.1007/s00192-025-06052-x. Epub 2025 Jan 28.
- Derived from this study: PubMed 34016168Carralero-Martinez A, Munoz Perez MA, Pane-Alemany R, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2021 May 20;22(1):356. doi: 10.1186/s13063-021-05321-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education and Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education in people with Pelvic Pain and Pelvic Pain Syndrome, run by RAPbarcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain (time frame: baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.