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

RAPbarcelona

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03797911

RAP39426977

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

active resistive capacitive monopolar radiofrequency

Experimental group

Description:

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.

Treatment:

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

Inactive resistive capacitive monopolar radiofrequency

Placebo Comparator group

Description:

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.

Treatment:

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