Electrolysis Technique vs Manual Therapy in Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT03163160|
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dyspareunia Pelvic Pain Pelvic Floor Disorders Musculoskeletal Pain Perineal Tear||Procedure: Pelvic floor manual therapy group Procedure: Pelvic floor electrolysis group||Not Applicable|
Dyspareunia is painful sexual intercourse and causes could be related to musculoskeletal pelvic floor muscles disorders (tenderness, trigger points, scars). There is evidence that manual therapy and intratissue percutaneous electrolysis can be effective for musculoskeletal pain disorders affecting muscles, tendons and fascias of the extremities but they have not been evaluated in pelvic floor muscle pain syndrome. The aim of this study is to compare manual therapy and EPI in the treatment of pelvic pain in women with dyspareunia.
Pelvic floor manual therapy is a clinical approach utilizing specifics hands-on mobilizing techniques to treat soft tissues. Pelvic floor mobilization is a slow controlled process of soft-tissue (myofascial) stretching intended to improve bio-mechanical elasticity.
EPI technique consists in an ultrasound-guided application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Intratissue Percutaneous Electrolysis Technique vs. Manual Therapy in Women With Dyspareunia and Pelvic Pain|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||October 20, 2018|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: Pelvic floor manual therapy group
Pelvic floor manual therapy is a clinical approach utilizing specifics hands-on mobilizing techniques to treat soft tissues. The technique require mobilization of soft-tissue by myofascial stretching maneuvers intended to improve bio-mechanical elasticity. The therapeutic protocol will be applied for 4 weeks.
Procedure: Pelvic floor manual therapy group
Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.
Other Name: Man Ther Group
Experimental: Pelvic floor electrolysis group
Pelvic floor electrolysis technique consists in an ultrasound-guided application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. The therapeutic protocol will be applied for 4 weeks.
Procedure: Pelvic floor electrolysis group
An ultrasound-guided application of a galvanic electrolytic current with an acupuncture needle in the soft tissue of pelvic floor. EPI technique was applied using a specifically device (EPI-X Omega Advanced Medicine, Barcelona, Spain) which produces modulated galvanic electricity. This is applied using a modified electrosurgical scalpel that incorporates acupuncture needles (0.3 mm in diameter) of different lengths. The intensity can be adjusted by changing either the duration of stimulation or the output current (mA) of the device.
One weekly session for four weeks.
Other Name: EPI
- Pain intensity before and after the intervention [ Time Frame: Seven days after weekly session ]Changes in pain intensity before and after the intervention. A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of perineal pain during the external and intra-vaginal examination.
- Female sexual function index [ Time Frame: Seven days after the last session and three months later ]Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163160
|Contact: Carolina Walker, PT, PhDfirstname.lastname@example.org|
|Hospital Universitario Quirón Madrid||Recruiting|
|Madrid, Spain, 28223|
|Contact: Carolina Walker, PhD 34 676493717 email@example.com|
|Principal Investigator:||Carolina Walker, PT, PhD||Hospital Universitario Quiron Madrid|