Clinical trial NCT03797911: Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT
Official title: Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Pelvic Pain Syndrome
Chronic Pain
Chronic Pain Syndrome
Chronic Pelvic Inflammatory Disease
Physical Therapy
Lead sponsor: RAPbarcelona
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
timeFrame: baseline and 10 weeks
Secondary outcomes:
measure: Assess quality of life
timeFrame: baseline, 5 and 10 weeks
measure: Assess kinesiophobia
timeFrame: baseline, 5 and 10 weeks
measure: Assess catastrophism
timeFrame: baseline, 5 and 10 weeks
measure: Assess the degree of adherence to treatment
timeFrame: 10 weeks
measure: Assess number of participants with high adherence to treatment
timeFrame: 10 weeks
measure: Assess number of participants with adverse effects
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Andrea Carralero Martinez
Study officials:
References:
citation: 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.