Dataset Information

Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. This study aims to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 kHz as an adjunct treatment to other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS.

Methods

This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into a CRMRF activated group or a CRMRF deactivated group and receive physiotherapeutic techniques and pain education. The groups will undergo treatment for 10 consecutive weeks. At the beginning of the trial there will be an evaluation of pain intensity (using VAS), quality of life (using the SF-12), kinesiophobia (using the TSK-11), and catastrophism (using the PCS), as well as at the sixth and tenth sessions.

Discussion

The results of this study will show that CRMRF benefits the treatment of patients with CPPS, together with physiotherapeutic techniques and pain education. These results could offer an alternative conservative treatment option for these patients.

Trial registration

ClinicalTrials.gov NCT03797911 . Registered on 8 January 2019.

SUBMITTER: Carralero-Martinez A

PROVIDER: S-EPMC8136758 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:To evaluate the reduction of perineal pain after vaginal deliveries by capacitive resistive radiofrequency therapy (RF). METHODS:We conducted a double-blind randomized study in University Hospital Centre in France. We included women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not). The participants were randomly assigned to RF or not at day 1 and day 2 postpartum. The primary outcome was pain evaluated as visual analog scale (VAS) score >4 at rest on day 2 after the treatment. Secondary outcomes included discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse were also assessed by phone call 30 days after delivery. We performed univariate analysis and multivariable regressions adjusting on the value of the outcome at baseline to improve precision of the estimated intervention effect. RESULTS:Between June 1, 2017 and October 8, 2017, the RF group included 29 women compared with 31 women in the group without RF. There was no significant difference on VAS >4 between the two groups (13.8% vs. 9.7% p = 0.69; difference = 4.1%, 95%CI -12.2%- 20.4%); consumption of paracetamol was lower in the RF group (978.3 mg (sd = 804.5) vs 1703.7 mg (sd = 1381.6), p = 0.035; difference = -725.3 mg, 95%CI -1359.6 - -91.3). Multivariate analysis showed no association between RF and pain. Nevertheless, we found an association between RF and discomfort while walking (adjusted OR 0.24, 95% CI 0.07-0.90; p = 0.03). CONCLUSION:VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery. CLINICAL TRIAL REGISTRATIONS:The study was registered in the Clinical Government trial (https://clinicaltrials.gov/ct2/show/NCT03172286?term=bretelle&rank=2) under the number NCT03172286.

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