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Completed

NCT Number: NCT03797911

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

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.

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Key information

Conditions

Pelvic Pain Chronic Pain Chronic Pain Syndrome Chronic Pelvic Inflammatory Disease Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Syndrome Physical Therapy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andrea Carralero Martinez

Barcelona, 08004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain

    Time frame: baseline and 10 weeks

    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.

Secondary outcomes

  1. Assess quality of life

    Time frame: baseline, 5 and 10 weeks

    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.

  2. Assess kinesiophobia

    Time frame: baseline, 5 and 10 weeks

    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.

  3. Assess catastrophism

    Time frame: baseline, 5 and 10 weeks

    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.

  4. Assess the degree of adherence to treatment

    Time frame: 10 weeks

    Assess the degree of adherence to treatment (%) of the patients who are in this study.

  5. Assess number of participants with high adherence to treatment

    Time frame: 10 weeks

    Assess the number of patients (n) with high adherence who are in this study.

  6. Assess number of participants with adverse effects

    Time frame: 10 weeks

    Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.

Sponsors and collaborators

Lead sponsor

RAPbarcelona

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2019
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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