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| ID | Type | Description | Link |
|---|---|---|---|
| HCB/2021/0313 | Other Identifier | Ethics Comittee - Hospital Clinic de Barcelona |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON RF | Active Comparator | Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group 1 will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 8 sessions, held weekly. |
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| OFF RF | Sham Comparator | Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the CONTROL group 2 will receive treatment with activated RF, with the electrode for 20 minutes per session during a total of 8 sessions, held weekly. |
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| MYOFASCIAL MANUAL THERAPY | Active Comparator | Application of the technique in the intervention group 2 (MYOFASCIAL MANUAL THERAPY): the intervention group 2 will receive treatment for 20 minutes per session during a total of 8 sessions, held weekly. |
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| NO TREATMENT | No Intervention | Patients in waiting list, pending treatment will not receive treatment but symptoms will be monitored after 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction) | 8 weeks |
| Quality of life (QoL) | Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest) |
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Inclusion criteria included women who were:
Exclusion criteria included the following:
WOMEN PRESENTING CHRONIC PELVIC PAIN
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla Box, PT, MSc | Contact | +34932275300 | cebox@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| myofascial manual therapy | Other | Myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home |
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| 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| Central sensitization | Using the central sensitization index (CSI). Ranging from 0-100, >40 is the cutoff for pain sensitization | 8 weeks |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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