None listed
Conditions
Brief summary
Capacitive and Resistive electric transfer (CRet) is a form of endogenous diathermy which has demonstrated to reduce pain and improve quality of life in several degenerative and inflammatory musculoskeletal conditions (Coccetta et al, 2019). These benefits are based on the significant improvement of blood circulation, the removal of pro-inflammatory catabolites and the warming of deep tissues, resulting in the relaxation of muscular tissue and drainage of oedema (Tashiro et al, 2017). Based on the above, the aim of this study will be to explore the effects of CRet therapy in women presenting PCPPS symptoms. The study will be a two-arm, prospective, multicentric randomized placebo-controlled trial investigating the efficacy of CRet diathermy in reducing pain and improving Health Related Quality of Life (HRQoL) and sexual function in females diagnosed with PCPPS.
Interventions
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 d
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.
Sponsors
Universidad de Castilla la Mancha
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed