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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 : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Carolina Walker Chao, 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.

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 : December 20, 2018
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Carolina Walker, PT, PhD 00-34676493717 carolina.gestos@gmail.com

Locations
Spain
Hospital Universitario Quirón Madrid Recruiting
Madrid, Spain, 28223
Contact: Carolina Walker, PhD    34 676493717    carolina.gestos@gmail.com   
Sponsors and Collaborators
Quirón Madrid University Hospital
Investigators
Principal Investigator: Carolina Walker, PT, PhD Hospital Universitario Quiron Madrid

Publications:

Responsible Party: Carolina Walker Chao, PhD, Quirón Madrid University Hospital
ClinicalTrials.gov Identifier: NCT03163160     History of Changes
Other Study ID Numbers: BET116183
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carolina Walker Chao, Quirón Madrid University Hospital:
pelvic floor muscles
pelvic floor myalgia
manual therapy
electrolysis
galvanic

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Pelvic Pain
Musculoskeletal Pain
Dyspareunia
Pelvic Floor Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Genital Diseases, Male
Mental Disorders
Pregnancy Complications