Electrolysis Technique vs Manual Therapy in Pelvic Pain

Musculoskeletal Pain Clinical Trial

Official title:

Intratissue Percutaneous Electrolysis Technique vs. Manual Therapy in Women With Dyspareunia and Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163160
• Other study ID #: BET116183
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: March 27, 2019

Study information

• Verified date: March 2019
• Source: Quirón Madrid University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Quirón Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Quirón Madrid University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibañez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI®) 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. — View Citation

Arias-Buría JL, Truyols-Domínguez S, Valero-Alcaide R, Salom-Moreno J, Atín-Arratibel MA, Fernández-de-Las-Peñas 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. — View 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. — View Citation

Leeman LM, Rogers RG. Sex after childbirth: postpartum sexual function. Obstet Gynecol. 2012 Mar;119(3):647-55. doi: 10.1097/AOG.0b013e3182479611. Review. — View 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. eCollection 2016 Apr-Jun. — View Citation

Moreno C, Mattiussi G, Núñez 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Female sexual function index	Sexual function measure by the six-item Female Sexual Function Index (FSFI-6)	Seven days after the last session and three months later