Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

Epicondylitis Clinical Trial

Official title:

Percutaneous Electrolysis and Vacuum Myofascial Therapy Device in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729400
• Other study ID #: Elctrolysis and vacuum
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2022
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.

Description:

Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home and the control group will be included 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.

Exclusion Criteria:

• Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with electrolysis and Vacuum Myofascial Therapy Device a month earlier

Related Conditions & MeSH terms

• Epicondylitis

Intervention

Device:
• Vacuum Myofascial Therapy device
Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.

Other:
• physical therapy program
The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.

Procedure:
• Therapeutic Percutaneous Electrolysis
Therapeutic Percutaneous Electrolysis
• ultrasound pulsatil therapy (US) and massage
ultrasound pulsatil therapy (US) and massage

Locations

Country	Name	City	State
Spain	Policlínica Santa María	Cadiz	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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

García Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30. — View Citation

Gündüz R, Malas FÜ, Borman P, Kocaoglu S, Özçakar L. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. 2012 May;31(5):807-12. doi: 10.1007/s10067-012-1939-y. Epub 2012 Jan 27. — View Citation

Huber R, Emerich M, Braeunig M. Cupping - is it reproducible? Experiments about factors determining the vacuum. Complement Ther Med. 2011 Apr;19(2):78-83. doi: 10.1016/j.ctim.2010.12.006. Epub 2011 Jan 22. — View Citation

Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23. — View Citation

Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070. — View Citation

Lauche R, Cramer H, Hohmann C, Choi KE, Rampp T, Saha FJ, Musial F, Langhorst J, Dobos G. The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study. Evid Based Complement Alternat Med. 2012;2012:429718. doi: 10.1155/2012/429718. Epub 2011 Dec 7. — View Citation

Leem J. Long-term effect of cupping for chronic neck pain. Integr Med Res. 2014 Dec;3(4):217-219. doi: 10.1016/j.imr.2014.10.001. Epub 2014 Oct 14. — View Citation

Rodríguez-Huguet M, Góngora-Rodríguez J, Lomas-Vega R, Martín-Valero R, Díaz-Fernández Á, Obrero-Gaitán E, Ibáñez-Vera AJ, Rodríguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7). pii: E2068. doi: 10.3390/jcm9072068. — View Citation

Rodríguez-Huguet M, Góngora-Rodríguez J, Rodríguez-Huguet P, Ibañez-Vera AJ, Rodríguez-Almagro D, Martín-Valero R, Díaz-Fernández Á, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6). pii: E1837. doi: 10.3390/jcm9061837. — View Citation

Rodríguez-Huguet M, Rodríguez-Huguet P, Lomas-Vega R, Ibáñez-Vera AJ, Rodríguez-Almagro D. Vacuum myofascial therapy device for non-specific neck pain. A single blind randomized clinical trial. Complement Ther Med. 2020 Aug;52:102449. doi: 10.1016/j.ctim.2020.102449. Epub 2020 May 30. — View Citation

Thong ISK, Jensen MP, Miró J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012. — View Citation

Valera-Garrido F, Minaya-Muñoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13. — View Citation

Walz DM, Newman JS, Konin GP, Ross G. Epicondylitis: pathogenesis, imaging, and treatment. Radiographics. 2010 Jan;30(1):167-84. doi: 10.1148/rg.301095078. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of pain in epicondylitis	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.	Baseline
Secondary	The intensity of pain in epicondylitis	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.	Four and twelve weeks
Secondary	Active elbow range of motion	Measured by a two branches egoniomter	Baseline,four and twelve weeks
Secondary	Pressure pain thresholds in epicondylitis trigger points	Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)	Baseline, four and twelve weeks
Secondary	Questionnaire SF 12	The multidimensional health related quality of life	Baseline,four and twelve weeks
Secondary	Scale PRTEE	PRTEE is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.	Baseline,four weeks and Twelve weeks.