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Electrolysis Technique vs Manual Therapy in Pelvic Pain

Primary Purpose

Dyspareunia, Pelvic Pain, Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pelvic floor manual therapy group
Pelvic floor electrolysis group
Sponsored by
Quirón Madrid University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring pelvic floor muscles, pelvic floor myalgia, manual therapy, electrolysis, galvanic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Universitario Quirón Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pelvic floor manual therapy group

Pelvic floor electrolysis group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pain intensity before and after the intervention
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

Female sexual function index
Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)

Full Information

First Posted
May 19, 2017
Last Updated
March 27, 2019
Sponsor
Quirón Madrid University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03163160
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Quirón Madrid University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Pelvic Pain, Pelvic Floor Disorders, Musculoskeletal Pain, Perineal Tear
Keywords
pelvic floor muscles, pelvic floor myalgia, manual therapy, electrolysis, galvanic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor manual therapy group
Arm Type
Experimental
Arm 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.
Arm Title
Pelvic floor electrolysis group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor manual therapy group
Other Intervention Name(s)
Man Ther Group
Intervention Description
Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor electrolysis group
Other Intervention Name(s)
EPI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity before and after the intervention
Description
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.
Time Frame
Seven days after weekly session
Secondary Outcome Measure Information:
Title
Female sexual function index
Description
Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)
Time Frame
Seven days after the last session and three months later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Walker, PT, PhD
Organizational Affiliation
Hospital Universitario Quiron Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Quirón Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11303195
Citation
Signorello LB, Harlow BL, Chekos AK, Repke JT. Postpartum sexual functioning and its relationship to perineal trauma: a retrospective cohort study of primiparous women. Am J Obstet Gynecol. 2001 Apr;184(5):881-8; discussion 888-90. doi: 10.1067/mob.2001.113855.
Results Reference
background
PubMed Identifier
22353966
Citation
Leeman LM, Rogers RG. Sex after childbirth: postpartum sexual function. Obstet Gynecol. 2012 Mar;119(3):647-55. doi: 10.1097/AOG.0b013e3182479611.
Results Reference
background
PubMed Identifier
25574678
Citation
Yong PJ, Mui J, Allaire C, Williams C. Pelvic floor tenderness in the etiology of superficial dyspareunia. J Obstet Gynaecol Can. 2014 Nov;36(11):1002-1009. doi: 10.1016/S1701-2163(15)30414-X.
Results Reference
background
PubMed Identifier
24568045
Citation
Bedaiwy MA, Patterson B, Mahajan S. Prevalence of myofascial chronic pelvic pain and the effectiveness of pelvic floor physical therapy. J Reprod Med. 2013 Nov-Dec;58(11-12):504-10.
Results Reference
background
PubMed Identifier
25527482
Citation
Zoorob D, South M, Karram M, Sroga J, Maxwell R, Shah A, Whiteside J. A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain. Int Urogynecol J. 2015 Jun;26(6):845-52. doi: 10.1007/s00192-014-2606-4. Epub 2014 Dec 20.
Results Reference
background
PubMed Identifier
24477495
Citation
Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.
Results Reference
background
PubMed Identifier
28116876
Citation
Moreno C, Mattiussi G, Nunez FJ, Messina G, Rejc E. Intratissue percutaneous electolysis combined with active physical therapy for the treatment of adductor longus enthesopathy-related groin pain: a randomized trial. J Sports Med Phys Fitness. 2017 Oct;57(10):1318-1329. doi: 10.23736/S0022-4707.16.06466-5. Epub 2017 Jan 23.
Results Reference
background
PubMed Identifier
27900300
Citation
Mattiussi G, Moreno C. Treatment of proximal hamstring tendinopathy-related sciatic nerve entrapment: presentation of an ultrasound-guided "Intratissue Percutaneous Electrolysis" application. Muscles Ligaments Tendons J. 2016 Sep 17;6(2):248-252. doi: 10.11138/mltj/2016.6.2.248. eCollection 2016 Apr-Jun.
Results Reference
background
PubMed Identifier
26649058
Citation
Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
Results Reference
background

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Electrolysis Technique vs Manual Therapy in Pelvic Pain

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