Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT

NCT ID: NCT03797911

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-23
• Study Completion Date: 2021-04-23

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active resistive capacitive monopolar radiofrequency

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.

Group Type: EXPERIMENTAL

Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education

Intervention Type: COMBINATION_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

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.

Group Type: PLACEBO_COMPARATOR

Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education

Intervention Type: COMBINATION_PRODUCT

Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.

Interventions

Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education

Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.

Intervention Type: COMBINATION_PRODUCT

Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education

Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Have an age equal to or greater than 18 years
• Having chronic pelvic pain of six or more months of evolution.

Exclusion Criteria

• 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).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RAPbarcelona

OTHER

Sponsor Role: lead

Responsible Party

Andrea Carralero Martínez

Physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andrea Carralero Martinez

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39873778 (View on PubMed)

Carralero-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.

Reference Type: DERIVED

PMID: 34016168 (View on PubMed)

Other Identifiers

RAP39426977

Identifier Type: -

Identifier Source: org_study_id