NCT04729400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

January 25, 2021

Last Update Submit

February 24, 2022

Conditions

Epicondylitis

Keywords

TendinopathyElectrolysisExerciseDry needingmassagecuppingvacuumnegative pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The intensity of pain in epicondylitis

    Four and twelve weeks

  • Active elbow range of motion

    Baseline,four and twelve weeks

  • Pressure pain thresholds in epicondylitis trigger points

    Baseline, four and twelve weeks

  • Questionnaire SF 12

    Baseline,four and twelve weeks

  • Scale PRTEE

    Baseline,four weeks and Twelve weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Vacuum Myofascial Therapy deviceProcedure: Therapeutic Percutaneous Electrolysis

CONTROL GROUP

EXPERIMENTAL

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

Other: physical therapy programProcedure: ultrasound pulsatil therapy (US) and massage

Interventions

Vacuum Myofascial Therapy deviceDEVICE

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

Experimental group
physical therapy programOTHER

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

CONTROL GROUP
Therapeutic Percutaneous ElectrolysisPROCEDURE

Therapeutic Percutaneous Electrolysis

Experimental group
ultrasound pulsatil therapy (US) and massagePROCEDURE

ultrasound pulsatil therapy (US) and massage

CONTROL GROUP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlínica Santa María

Cadiz, Cádiz, 11007, Spain

Location

Related Publications (15)

  • 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.

    PMID: 25122629BACKGROUND

  • 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.

    PMID: 20083592BACKGROUND

  • 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.

    PMID: 32630241BACKGROUND

  • 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: 26649058BACKGROUND

  • 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.

    PMID: 28135129BACKGROUND

  • 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.

    PMID: 32545583BACKGROUND

  • 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.

    PMID: 30397006BACKGROUND

  • 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.

    PMID: 19423657BACKGROUND

  • 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.

    PMID: 28664101BACKGROUND

  • 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.

    PMID: 21549258BACKGROUND

  • 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.

    PMID: 22203873BACKGROUND

  • 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.

    PMID: 29794282BACKGROUND

  • 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.

    PMID: 32951712BACKGROUND

  • 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.

    PMID: 22278162BACKGROUND

  • 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.

    PMID: 38453573DERIVED

MeSH Terms

Conditions

TendinopathyMotor Activity

Interventions

Massage

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • manuel Rodríguez Huguet, Physiotherapy

    University of Cádiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Outcomes assesor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A specialist physician will be diagnosed the epicondylitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 28, 2021

Study Start

June 10, 2021

Primary Completion

September 30, 2021

Study Completion

October 30, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

ES(1)