Chronic Pelvic Pain
Conditions
Keywords
chronic pelvic pain, myofascial syndrome, radiofrequency, manual therapy
Brief summary
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).
Interventions
DEVICERadiofrequency therapy
Radiofrequency 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
OTHERmyofascial manual therapy
Myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
included women who were: * 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 * Agreed to sign the informed consent form.
Exclusion criteria
included the following: * 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 * Patients with a history of pelvic cancer, including those who had undergone chemotherapy, radiotherapy, and/or brachytherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 8 weeks | Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function | 8 weeks | Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction) |
| Quality of life (QoL) | 8 weeks | Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest) |
| Pain catastrophizing | 8 weeks | 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 | 8 weeks | 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 |
| Central sensitization | 8 weeks | Using the central sensitization index (CSI). Ranging from 0-100, \>40 is the cutoff for pain sensitization |
Countries
Spain
Contacts
Primary ContactCarla Box, PT, MSc
Outcome results
None listed