Electrolysis Technique vs Manual Therapy in Pelvic Pain

NCT03163160 | Completed

• 1 other identifier: BET116183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pelvic floor muscles; pelvic floor myalgia; manual therapy; electrolysis; galvanic

Outcome Measures

Primary Outcomes (1)

• 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.

  Seven days after weekly session

Secondary Outcomes (1)

• Female sexual function index

  Seven days after the last session and three months later

Study Arms (2)

Pelvic floor manual therapy group

EXPERIMENTAL

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

Pelvic floor electrolysis group

EXPERIMENTAL

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

Interventions

Pelvic floor manual therapy group PROCEDURE

Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.

Also known as: Man Ther Group

Pelvic floor manual therapy group

Pelvic floor electrolysis group PROCEDURE

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.

Also known as: EPI

Pelvic floor electrolysis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quirón Madrid University Hospital: lead

Study Sites (1)

Hospital Universitario Quirón Madrid

Madrid, 28223, Spain

Location

Related Publications (9)

• 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: 11303195 BACKGROUND

• Leeman LM, Rogers RG. Sex after childbirth: postpartum sexual function. Obstet Gynecol. 2012 Mar;119(3):647-55. doi: 10.1097/AOG.0b013e3182479611.

  PMID: 22353966 BACKGROUND

• 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: 25574678 BACKGROUND

• 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: 24568045 BACKGROUND

• 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: 25527482 BACKGROUND

• 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: 24477495 BACKGROUND

• 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: 28116876 BACKGROUND

• 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: 27900300 BACKGROUND

• 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.

  PMID: 26649058 BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Pelvic Pain; Pelvic Floor Disorders; Musculoskeletal Pain; Vaginismus

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Muscular Diseases; Musculoskeletal Diseases; Vaginal Diseases

Study Officials

• Carolina Walker, PT, PhD

  Hospital Universitario Quiron Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: June 20, 2017
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)