Electrolysis Technique vs Manual Therapy in Pelvic Pain

Quirón Madrid University Hospital

Status: Completed

Conditions: Musculoskeletal Pain; Pelvic Floor Disorders; Dyspareunia; Pelvic Pain; Perineal Tear

Treatments: Procedure: Pelvic floor manual therapy group; Procedure: Pelvic floor electrolysis group

Study type: Interventional

Funder types: Other

Identifiers

NCT03163160

BET116183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Pelvic floor manual therapy group

Experimental group

Description:

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.

Treatment:

Procedure: Pelvic floor manual therapy group

Pelvic floor electrolysis group

Experimental group

Description:

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.

Treatment:

Procedure: Pelvic floor electrolysis group