A randomised clinical trial is being conducted in the Gynecology Department of the Hospital Clinic de Barcelona in women presenting chronic pelvic pain syndrome due to a myofascial cause which is over a 4 score in the VAS scale and not related to an obstetric injury. This study presents 4 groups; two groups receive 8 radiofrequency sessions, one group receives 8 sessions of myofascial release therapy (MRT) and the last group receives no treatment at all (NT). The two RF groups have been divided into a RF intervention group (RFIG) and a RF control group (RFCG) which receives sham treatment. The RF groups are double-blinded. Other than RF, both groups perform daily Thiele massage at home. The sessions last for 20 minutes and take place once a week during 8 weeks.
The main variable evaluated is the level of pain during the muscular assessment carried out by an expert pelvic floor physical therapist using the Verbal numeric Scale in the first session and at the end of the 8 sessions. Secondary variables are: sexual function (throughout FSFI questionnaire), pain catastrophizing (ECD), quality of life (EQ5D), anxiety and depression (HADS), central sensitization (CSI) as well as other pelvic floor dysfunction symptoms (PFDI).
At least 18 years of age
Presenting with pelvic pain persisting for at least 6 months
Diagnosed with myofascial syndrome of the pelvic floor muscles (PFM) by a specialist based on physical assessment
Presenting with pelvic pain intensity greater than 4 on the Visual Analog Scale (VAS) in the last 3 months
Patients who were pregnant
Postpartum patients who had given birth within the last year
Patients with a history of vulvovaginal pathology
Contraindications for the use of radiofrequency: metal implants or active infection
Parallel
Radiofrequency therapy
DeviceRadiofrequency or myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
myofascial manual therapy
Other interventionMyofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Pain Level
Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)
Sexual function
Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction)
Quality of life (QoL)
Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest)
Pain catastrophizing
Using the pain catastrophizing scale (PCS).Ranges from 0 to 52 where higher scores indicate a greater degree of pain catastrophizing. A total score of \>30 represents a clinically significant level of pain catastrophization
Anxiety and depression
Anxiety and depression using the Hospital Anxiety and depression Scale (HADS). Generally, scores of 0 to 7 on this questionnaire are considered to be normal, scores of 8 to 10 indicate mild symptoms, 11 to 14 indicate moderate symptoms, and 15 to 21 indicate severe symptoms
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