Back to resultsEfficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT
Primary Purpose
Pelvic Pain, Pelvic Pain Syndrome, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain
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.
Sites / Locations
- Andrea Carralero Martinez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
active resistive capacitive monopolar radiofrequency
Inactive resistive capacitive monopolar radiofrequency
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Assess the degree of adherence to treatment
Assess the degree of adherence to treatment (%) of the patients who are in this study.
Assess number of participants with high adherence to treatment
Assess the number of patients (n) with high adherence who are in this study.
Assess number of participants with adverse effects
Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03797911
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2019 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAPbarcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Pelvic Pain Syndrome, Chronic Pain, Chronic Pain Syndrome, Chronic Pelvic Inflammatory Disease, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple blind
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active resistive capacitive monopolar radiofrequency
Arm Type
Experimental
Arm 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.
Arm Title
Inactive resistive capacitive monopolar radiofrequency
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
Intervention Description
Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
Intervention Type
Combination Product
Intervention Name(s)
Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
Intervention Description
Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
Primary Outcome Measure Information:
Title
Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
Description
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.
Time Frame
baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Assess quality of life
Description
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.
Time Frame
baseline, 5 and 10 weeks
Title
Assess kinesiophobia
Description
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.
Time Frame
baseline, 5 and 10 weeks
Title
Assess catastrophism
Description
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.
Time Frame
baseline, 5 and 10 weeks
Title
Assess the degree of adherence to treatment
Description
Assess the degree of adherence to treatment (%) of the patients who are in this study.
Time Frame
10 weeks
Title
Assess number of participants with high adherence to treatment
Description
Assess the number of patients (n) with high adherence who are in this study.
Time Frame
10 weeks
Title
Assess number of participants with adverse effects
Description
Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Andrea Carralero Martinez
City
Barcelona
ZIP/Postal Code
08004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34016168
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.
Results Reference
derived
Learn more about this trial
Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT
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