Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

NCT ID: NCT04729400

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A specialist physician will be diagnosed the epicondylitis
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Outcomes assesor

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Vacuum Myofascial Therapy device

Intervention Type DEVICE

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

Therapeutic Percutaneous Electrolysis

Intervention Type PROCEDURE

Therapeutic Percutaneous Electrolysis

CONTROL GROUP

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

Group Type EXPERIMENTAL

physical therapy program

Intervention Type OTHER

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

ultrasound pulsatil therapy (US) and massage

Intervention Type PROCEDURE

ultrasound pulsatil therapy (US) and massage

Interventions

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Vacuum Myofascial Therapy device

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Therapeutic Percutaneous Electrolysis

Therapeutic Percutaneous Electrolysis

Intervention Type PROCEDURE

ultrasound pulsatil therapy (US) and massage

ultrasound pulsatil therapy (US) and massage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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manuel Rodríguez Huguet, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

University of Cádiz

Locations

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Policlínica Santa María

Cadiz, Cádiz, Spain

Site Status

Countries

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Spain

References

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Valera-Garrido F, Minaya-Munoz 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.

Reference Type BACKGROUND
PMID: 25122629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20083592 (View on PubMed)

Rodriguez-Huguet M, Gongora-Rodriguez J, Lomas-Vega R, Martin-Valero R, Diaz-Fernandez A, Obrero-Gaitan E, Ibanez-Vera AJ, Rodriguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7):2068. doi: 10.3390/jcm9072068.

Reference Type BACKGROUND
PMID: 32630241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26649058 (View on PubMed)

Garcia 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.

Reference Type BACKGROUND
PMID: 28135129 (View on PubMed)

Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.

Reference Type BACKGROUND
PMID: 32545583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30397006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19423657 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 28664101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21549258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22203873 (View on PubMed)

Thong ISK, Jensen MP, Miro 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.

Reference Type BACKGROUND
PMID: 29794282 (View on PubMed)

Rodriguez-Huguet M, Rodriguez-Huguet P, Lomas-Vega R, Ibanez-Vera AJ, Rodriguez-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.

Reference Type BACKGROUND
PMID: 32951712 (View on PubMed)

Gunduz R, Malas FU, Borman P, Kocaoglu S, Ozcakar 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.

Reference Type BACKGROUND
PMID: 22278162 (View on PubMed)

Rodriguez-Huguet M, Rodriguez-Almagro D, Rosety-Rodriguez MA, Vinolo-Gil MJ, Molina-Jimenez J, Gongora-Rodriguez J. Pulsed negative pressure myofascial vacuum therapy and percutaneous electrolysis in the treatment of lateral epicondylalgia: A single-blind randomized controlled trial. J Hand Ther. 2024 Oct-Dec;37(4):644-652. doi: 10.1016/j.jht.2024.02.003. Epub 2024 Mar 6.

Reference Type DERIVED
PMID: 38453573 (View on PubMed)

Other Identifiers

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Elctrolysis and vacuum

Identifier Type: -

Identifier Source: org_study_id

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