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

Chronic Pain Clinical Trial

Official title:

Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797911
• Other study ID #: RAP39426977
• Status: Completed
• Phase: N/A
• Start date: March 23, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: December 2021
• Source: RAPbarcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 23, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Chronic Pelvic Inflammatory Disease
• Pelvic Inflammatory Disease
• Pelvic Pain
• Pelvic Pain Syndrome
• Physical Therapy
• Somatoform Disorders
• Syndrome

Intervention

Combination Product:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Andrea Carralero Martinez	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
RAPbarcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, 5 and 10 weeks
Secondary	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.	baseline, 5 and 10 weeks
Secondary	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.	baseline, 5 and 10 weeks
Secondary	Assess the degree of adherence to treatment	Assess the degree of adherence to treatment (%) of the patients who are in this study.	10 weeks
Secondary	Assess number of participants with high adherence to treatment	Assess the number of patients (n) with high adherence who are in this study.	10 weeks
Secondary	Assess number of participants with adverse effects	Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.	10 weeks