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

NCT03797911 | Completed

• 1 other identifier: RAP39426977
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Pelvic Pain Syndrome; Chronic Pain; Chronic Pain Syndrome; Chronic Pelvic Inflammatory Disease; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 10 weeks

Secondary Outcomes (6)

• Assess quality of life

  baseline, 5 and 10 weeks

• Assess kinesiophobia

  baseline, 5 and 10 weeks

• Assess catastrophism

  baseline, 5 and 10 weeks

• Assess the degree of adherence to treatment

  10 weeks

• Assess number of participants with high adherence to treatment

  10 weeks

Study Arms (2)

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.

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.

Combination Product: Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education

Interventions

Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education COMBINATION_PRODUCT

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

active resistive capacitive monopolar radiofrequency

Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education COMBINATION_PRODUCT

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

Inactive resistive capacitive monopolar radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAPbarcelona: lead

Study Sites (1)

Andrea Carralero Martinez

Barcelona, 08004, Spain

Location

Related Publications (2)

• 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.

  PMID: 39873778 DERIVED

• 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.

  PMID: 34016168 DERIVED

MeSH Terms

Conditions

Pelvic Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 9, 2019
• Study Start: March 23, 2019
• Primary Completion: April 16, 2021
• Study Completion: April 23, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)