Clinical trial NCT03163160: Electrolysis Technique vs Manual Therapy in Pelvic Pain
Official title: Intratissue Percutaneous Electrolysis Technique vs. Manual Therapy in Women With Dyspareunia and Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspareunia
Pelvic Pain
Pelvic Floor Disorders
Musculoskeletal Pain
Perineal Tear
Keywords: pelvic floor muscles
pelvic floor myalgia
manual therapy
electrolysis
galvanic
Lead sponsor: Quirón Madrid University Hospital
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity before and after the intervention
timeFrame: Seven days after weekly session
Secondary outcomes:
measure: Female sexual function index
timeFrame: Seven days after the last session and three months later
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Quirón Madrid
Study officials:
affiliation: Hospital Universitario Quiron Madrid
name: Carolina Walker, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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