Clinical Trials Directory

Trials / Completed

CompletedNCT03163160

Electrolysis Technique vs Manual Therapy in Pelvic Pain

Intratissue Percutaneous Electrolysis Technique vs. Manual Therapy in Women With Dyspareunia and Pelvic Pain

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Quirón Madrid University Hospital · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue percutaneous electrolysis (EPI) technique in the treatment of pelvic pain in women with dyspareunia. Half of participants will receive pelvic floor manual therapy while the other half will receive intratissue percutaneous electrolysis technique.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPelvic floor manual therapy groupSoft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.
PROCEDUREPelvic floor electrolysis groupAn 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.

Timeline

Start date
2017-06-20
Primary completion
2019-03-27
Completion
2019-03-27
First posted
2017-05-22
Last updated
2019-03-28

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03163160. Inclusion in this directory is not an endorsement.