Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000726752
Ethics application status
Approved
Date submitted
10/04/2022
Date registered
20/05/2022
Date last updated
20/05/2022
Date data sharing statement initially provided
20/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of contact diathermy on pain and quality of life in women with Primary Chronic Pelvic Pain Syndrome: A randomized placebo-controlled trial.
Scientific title
Efficacy of Capacitive and Resistive Electric Transfer (CRet) in the management of pain in Primary Chronic Pelvic Pain Syndrome in women: A randomized placebo-controlled trial.
Secondary ID [1] 306889 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Chronic Pelvic Pain Syndrome 325988 0
Condition category
Condition code
Anaesthesiology 323485 323485 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm:
Subjects in this group will receive 6 CRet sessions over a period of 6 weeks (one session per week). CRet will be delivered using a “FisioWarm Pure” (Golden Star Srl, Roma, Italy) device, capable of delivering a peak power of 300 W when is set to continuous wave radiofrequency emission.
Each session will consist on the application of 30 minutes of CRet using the resistive modality (non-isolated metallic electrodes) and an output frequency set at 500 kHz. Each session will be divided into an extra-vaginal treatment and a subsequent intra-vaginal treatment.
The first 15 minutes will involve a fixed static application using 4 small, round metallic electrodes positioned over the suprapubic area. A high conductivity cream will be used as a coupling medium between the resistive electrodes and the skin surface.
The second 15 minutes will consist on the delivery of radiofrequency energy through the application of an intracavitary resistive electrode.
For both applications, the return (neutral) plate will be placed under the subject’s lumbosacral area. The intensity of the application will be constantly monitored and adjusted by the therapist according to patients’ feedback, trying to maintain a moderate heating sensation, always within their comfort limits.
Each attendance will be registered both manually in the appropriate Case Report Form (CRF) and electronically.
Intervention code [1] 323344 0
Treatment: Devices
Comparator / control treatment
Control Arm:
Subjects in this group will receive 6 CRet sessions over a period of 6 weeks (one session per week) too. CRet will be delivered using a “FisioWarm Pure” (Golden Star Srl, Roma, Italy) device, following the same protocol described above, but the output power will be set to the minimum allowed by the device for the first few seconds and then it will be set to 0 for the duration of each session.
Control group
Placebo

Outcomes
Primary outcome [1] 331036 0
Pain intensity with 100 mm visual analogue scale (VAS).
Timepoint [1] 331036 0
Baseline, before each CRet session, one week (primary timepoint) and 6 weeks after intervention is finished.
Primary outcome [2] 331037 0
Pain rating Index (PRI) as measured by the McGill Pain Questionnaire
Timepoint [2] 331037 0
Baseline, one week (primary timepoint) and 6 weeks after completing treatment protocol.
Secondary outcome [1] 408563 0
Quality of Life (QoL) using the WHOQOL-BREF questionnaire.
Timepoint [1] 408563 0
Baseline, one week and 6 weeks after completing study protocol.
Secondary outcome [2] 408564 0
Average electromyographic (EMG) activity of pelvic floor muscles (PFM), over a minimum period of 100 seconds will be measured in µV at rest, with participants in a crook lying supine position.
Timepoint [2] 408564 0
Baseline, one week and 6 weeks after completing study protocol.
Secondary outcome [3] 408565 0
Sexual Function as measured by the Female Sexual Function Index (FSFI).
Timepoint [3] 408565 0
Baseline, one week and 6 weeks after completing study protocol.
Secondary outcome [4] 408566 0
Global Response Assessment (GRA), using a 7-item Likert-type scale.
Timepoint [4] 408566 0
6 weeks after completion of study protocol.

Eligibility
Key inclusion criteria
- Women diagnosed of CPPS according to the definition by the European Urology Association (EUA).
- Presence of tenderness on palpation of Levator Ani (LA) muscle during vaginal examination.
- Presence of abnormal tension at rest within the PFM as indicated by surface electromyographic (EMG) signal (for the purpose of this study, this is defined as mean PFM EMG resting activity above 5 microV over a minimum period of 100 secs).
- Pharmacological treatment had remained stable for a minimum of 4 weeks prior to initiation of CRet therapy.
- Able and willing to provide informed consent.
- CRet treatment naive.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or trying to get pregnant.
- Women presenting with an abnormal cell cytology on last smear test.
- Local malignancy/tumours.
- Women with a pace-maker fitted.
- Presence of open wounds in the treatment area.
- Presence of thrombosis/impaired circulation in the treatment area.
- Exposure to X Ray therapy or other ionizing radiations in the previous 6 months.
- Those with impaired/absent sensation in the treatment.
- Those unable to comprehend the physiotherapist’s instructions or who were unable to co-operate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be allocated using numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a pooled standard deviation of 16.36 mm in VAS (obtained from a previous pilot study) a sample size of 19 subjects per arm will be required to achieve a level of significance of 0.05 and 80% statistical power to detect a significant difference of 15 mm in VAS pain scale.
22 participants for each group will be recruited to accommodate a 15% drop-out rate.
Data will be analysed on an intention-to-treat basis using SPSS software (SPSS®version 22, SPSS,IBM Corporation, NY, USA) .Categorical data will be described as absolute frequencies and percentages and will be compared with the Chi-squared test. All end points will be measured on a continuous scale. Those normally distributed will be indicated as mean (standard deviation), while variables not normally distributed will be described as median and interquartile range (IQR). Within and between groups comparisons will be performed using two-way repeated measures ANOVA (time x group) for normally distributed data or Friedman’s test as the non-parametric alternative. Post-hoc analysis with Bonferroni correction will be undertaken only when significant differences are found.
All results will be two-sided and p < 0.05 will indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/05/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 24719 0
Spain
State/province [1] 24719 0
Madrid

Funding & Sponsors
Funding source category [1] 311204 0
Self funded/Unfunded
Name [1] 311204 0
Country [1] 311204 0
Primary sponsor type
University
Name
Universidad de Castilla la Mancha
Address
Edificio José Prat .
Plaza de la Universidad nº 2.
02071 Albacete
Country
Spain
Secondary sponsor category [1] 312574 0
None
Name [1] 312574 0
Address [1] 312574 0
Country [1] 312574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310733 0
Comité de Ética de la Investigación Hospital Universitario de Fuenlabrada
Ethics committee address [1] 310733 0
Ethics committee country [1] 310733 0
Spain
Date submitted for ethics approval [1] 310733 0
04/03/2022
Approval date [1] 310733 0
25/03/2022
Ethics approval number [1] 310733 0
IRB: 22/37

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118678 0
Mr Miguel Martín García
Address 118678 0
Centro de Fisioterapia Pérez-Ondina
C/Simón Hernández, 53.
28936 Móstoles
Madrid
Country 118678 0
Spain
Phone 118678 0
+34 722 369 321
Fax 118678 0
Email 118678 0
[email protected]
Contact person for public queries
Name 118679 0
Miguel Martín García
Address 118679 0
Centro de Fisioterapia Pérez-Ondina
C/Simón Hernández, 53.
28936 Móstoles
Madrid
Country 118679 0
Spain
Phone 118679 0
+34 722 369 321
Fax 118679 0
Email 118679 0
[email protected]
Contact person for scientific queries
Name 118680 0
Miguel Martín García
Address 118680 0
Centro de Fisioterapia Pérez-Ondina
C/Simón Hernández, 53.
28936 Móstoles
Madrid
Country 118680 0
Spain
Phone 118680 0
+34 722 369 321
Fax 118680 0
Email 118680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication/no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to request to Principal Investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.