Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 10:28 PM
Study NCT ID:
NCT03163160
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrolysis Technique vs Manual Therapy in Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D052065', 'term': 'Vaginismus'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2017-05-19', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity before and after the intervention', 'timeFrame': 'Seven days after weekly session', '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."}], 'secondaryOutcomes': [{'measure': 'Female sexual function index', 'timeFrame': 'Seven days after the last session and three months later', 'description': 'Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic floor muscles', 'pelvic floor myalgia', 'manual therapy', 'electrolysis', 'galvanic'], 'conditions': ['Dyspareunia', 'Pelvic Pain', 'Pelvic Floor Disorders', 'Musculoskeletal Pain', 'Perineal Tear']}, 'referencesModule': {'references': [{'pmid': '11303195', 'type': 'BACKGROUND', '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.'}, {'pmid': '22353966', 'type': 'BACKGROUND', 'citation': 'Leeman LM, Rogers RG. Sex after childbirth: postpartum sexual function. Obstet Gynecol. 2012 Mar;119(3):647-55. doi: 10.1097/AOG.0b013e3182479611.'}, {'pmid': '25574678', 'type': 'BACKGROUND', '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.'}, {'pmid': '24568045', 'type': 'BACKGROUND', '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.'}, {'pmid': '25527482', 'type': 'BACKGROUND', '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.'}, {'pmid': '24477495', 'type': 'BACKGROUND', '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.'}, {'pmid': '28116876', 'type': 'BACKGROUND', '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.'}, {'pmid': '27900300', 'type': 'BACKGROUND', '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.'}, {'pmid': '26649058', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPelvic 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.\n\nEPI 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* At least three months postpartum or any gynecology surgery\n\nExclusion Criteria:\n\n* pregnancy\n* active urinary or vaginal infection\n* pelvic pathology associated with a lower genital pain problem (e.g. deep dyspareunia) and constant, spontaneous vulvar pain\n* younger than 18 or older than 65 years\n* previous interventions with steroid injections\n* fibromyalgia syndrome'}, 'identificationModule': {'nctId': 'NCT03163160', 'briefTitle': 'Electrolysis Technique vs Manual Therapy in Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Quirón Madrid University Hospital'}, 'officialTitle': 'Intratissue Percutaneous Electrolysis Technique vs. Manual Therapy in Women With Dyspareunia and Pelvic Pain', 'orgStudyIdInfo': {'id': 'BET116183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic floor manual therapy 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.', 'interventionNames': ['Procedure: Pelvic floor manual therapy group']}, {'type': 'EXPERIMENTAL', 'label': 'Pelvic floor electrolysis 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.', 'interventionNames': ['Procedure: Pelvic floor electrolysis group']}], 'interventions': [{'name': 'Pelvic floor manual therapy group', 'type': 'PROCEDURE', 'otherNames': ['Man Ther Group'], 'description': 'Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.', 'armGroupLabels': ['Pelvic floor manual therapy group']}, {'name': 'Pelvic floor electrolysis group', 'type': 'PROCEDURE', 'otherNames': ['EPI'], '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.\n\nOne weekly session for four weeks.', 'armGroupLabels': ['Pelvic floor electrolysis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quirón Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carolina Walker, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Quiron Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quirón Madrid University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Carolina Walker Chao', 'investigatorAffiliation': 'Quirón Madrid University Hospital'}}}}