Electrolysis Technique vs Manual Therapy in Pelvic Pain

Not Applicable

Completed

• Conditions: Dyspareunia; Pelvic Floor Disorders; Musculoskeletal Pain; Pelvic Pain; Perineal Tear
• Interventions: Procedure: Pelvic floor electrolysis group; Procedure: Pelvic floor manual therapy group

• Registration Number: NCT03163160
• Lead Sponsor: Quirón Madrid University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2017-06-20
• Status Verified: 2019-03
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• women with pain in the perineal area at an average intensity of 5 or more on the Numerical Rating Scale (NRS) during penetration or during pelvic examination, which is indicative of moderate to severe pain
• At least three months postpartum or any gynecology surgery

Exclusion Criteria

• pregnancy
• active urinary or vaginal infection
• pelvic pathology associated with a lower genital pain problem (e.g. deep dyspareunia) and constant, spontaneous vulvar pain
• younger than 18 or older than 65 years
• previous interventions with steroid injections
• fibromyalgia syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor electrolysis group	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.
Pelvic floor manual therapy group	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity before and after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Female sexual function index	Seven days after the last session and three months later	Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)

Trial Locations

Locations (1)

Hospital Universitario Quirón Madrid; 🇪🇸 Madrid, Spain