NCT05238090

Brief Summary

Evaluation of the applying a stretching protocol to lateral epicondylitis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

February 3, 2022

Last Update Submit

February 18, 2022

Conditions

Keywords

epicondylitisElbow Tendinopathystretchphysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Elbow Pain

    Measurement of pain perception: by means of a visual analogue scale (VAS), consisting of drawing a 100 mm long line in a centred position on a DINA A4 paper, cut with a segment perpendicular to it at each end. After informing the subject that the left and right segments represent the absence of pain and the maximum pain imaginable respectively, the subject is asked to point with a pencil on the line to the point where their pain is located.

    1,5 months

  • Grip strength

    A dynamometer shall be used for the test. Special care was taken to ensure that all subjects had the same position in order to be able to compare results. After informing the patient how to perform this test, the evaluation process consists of performing a maximum grip force for three seconds, executing it three times and with a minimum time interval of 60 seconds between them to avoid muscle fatigue. After completion of the test, the arithmetic mean of the results will be considered as the result.

    1,5 months

Study Arms (2)

Control group

OTHER

Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature

Other: Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature

Experimental

EXPERIMENTAL

Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet

Other: Passive and active analytical stretching exercises

Interventions

For each stretching technique described, 3 repetitions of 15 seconds duration will be performed of 15 seconds duration each, within the patient's tolerance threshold. In any case, the impossibility of performing any technique due to exacerbation of pain shall be recorded in a patient record created for this study, noting the technique in question and the reason for its technique in question and the reason for its non-application. Passive stretches shall be applied in the same order for all subjects. The physiotherapists in charge of applying the treatments will be trained in advance in the different techniques to be applied and will not in the different techniques to be applied and shall not intervene at any time in the two previous phases. Both the control group and the study group will receive their respective treatments two days a week for four weeks. In no case will any other type of treatment be associated treatment during the whole process.

Experimental

Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature

Control group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects over 18 years of age.
  • Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.

You may not qualify if:

  • Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research.
  • Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research.
  • Patients in a situation of legal litigation that could be affected by their participation in this study.
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • Knutsen EJ, Calfee RP, Chen RE, Goldfarb CA, Park KW, Osei DA. Factors associated with failure of nonoperative treatment in lateral epicondylitis. Am J Sports Med. 2015 Sep;43(9):2133-7. doi: 10.1177/0363546515590220. Epub 2015 Jun 29.

    PMID: 26122386BACKGROUND
  • Sanders TL Jr, Maradit Kremers H, Bryan AJ, Ransom JE, Smith J, Morrey BF. The epidemiology and health care burden of tennis elbow: a population-based study. Am J Sports Med. 2015 May;43(5):1066-71. doi: 10.1177/0363546514568087. Epub 2015 Feb 5.

    PMID: 25656546BACKGROUND
  • Haahr JP, Andersen JH. Physical and psychosocial risk factors for lateral epicondylitis: a population based case-referent study. Occup Environ Med. 2003 May;60(5):322-9. doi: 10.1136/oem.60.5.322.

    PMID: 12709516BACKGROUND
  • Fathy AA. Iontophoresis Versus Cyriax-Type exercises in Chronic Tennis Elbow among industrial workers. Electron Physician. 2015 Sep 16;7(5):1277-83. doi: 10.14661/1277. eCollection 2015 Sep.

    PMID: 26435828BACKGROUND
  • Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.

    PMID: 16968862BACKGROUND
  • Greenbaum B, Itamura J, Vangsness CT, Tibone J, Atkinson R. Extensor carpi radialis brevis. An anatomical analysis of its origin. J Bone Joint Surg Br. 1999 Sep;81(5):926-9. doi: 10.1302/0301-620x.81b5.9566.

    PMID: 10530864BACKGROUND
  • Coel M, Yamada CY, Ko J. MR imaging of patients with lateral epicondylitis of the elbow (tennis elbow): importance of increased signal of the anconeus muscle. AJR Am J Roentgenol. 1993 Nov;161(5):1019-21. doi: 10.2214/ajr.161.5.8273602.

    PMID: 8273602BACKGROUND
  • Baker CL Jr, Murphy KP, Gottlob CA, Curd DT. Arthroscopic classification and treatment of lateral epicondylitis: two-year clinical results. J Shoulder Elbow Surg. 2000 Nov-Dec;9(6):475-82. doi: 10.1067/mse.2000.108533.

    PMID: 11155299BACKGROUND
  • Babaei-Ghazani A, Shahrami B, Fallah E, Ahadi T, Forough B, Ebadi S. Continuous shortwave diathermy with exercise reduces pain and improves function in Lateral Epicondylitis more than sham diathermy: A randomized controlled trial. J Bodyw Mov Ther. 2020 Jan;24(1):69-76. doi: 10.1016/j.jbmt.2019.05.025. Epub 2019 May 24.

    PMID: 31987565BACKGROUND
  • Yelland M, Rabago D, Ryan M, Ng SK, Vithanachchi D, Manickaraj N, Bisset L. Prolotherapy injections and physiotherapy used singly and in combination for lateral epicondylalgia: a single-blinded randomised clinical trial. BMC Musculoskelet Disord. 2019 Nov 3;20(1):509. doi: 10.1186/s12891-019-2905-5.

    PMID: 31679521BACKGROUND
  • Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.

    PMID: 31104005BACKGROUND
  • Buchbinder R, Green SE, Struijs P. Tennis elbow. BMJ Clin Evid. 2008 May 28;2008:1117.

    PMID: 19450309BACKGROUND
  • Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70.

    PMID: 1423702BACKGROUND
  • Terra BB, Rodrigues LM, Filho AN, de Almeida GD, Cavatte JM, De Nadai A. Arthroscopic treatment for chronic lateral epicondylitis. Rev Bras Ortop. 2015 Jul 9;50(4):395-402. doi: 10.1016/j.rboe.2015.06.015. eCollection 2015 Jul-Aug.

    PMID: 26401498BACKGROUND
  • Seng C, Mohan PC, Koh SB, Howe TS, Lim YG, Lee BP, Morrey BF. Ultrasonic Percutaneous Tenotomy for Recalcitrant Lateral Elbow Tendinopathy: Sustainability and Sonographic Progression at 3 Years. Am J Sports Med. 2016 Feb;44(2):504-10. doi: 10.1177/0363546515612758. Epub 2015 Nov 24.

    PMID: 26602153BACKGROUND
  • Abbott JH. Mobilization with movement applied to the elbow affects shoulder range of movement in subjects with lateral epicondylalgia. Man Ther. 2001 Aug;6(3):170-7. doi: 10.1054/math.2001.0407.

    PMID: 11527457BACKGROUND
  • Lucado AM, Kolber MJ, Cheng MS, Echternach JL Sr. Upper extremity strength characteristics in female recreational tennis players with and without lateral epicondylalgia. J Orthop Sports Phys Ther. 2012 Dec;42(12):1025-31. doi: 10.2519/jospt.2012.4095. Epub 2012 Sep 5.

    PMID: 22960729BACKGROUND
  • Madding SW, Wong JG, Hallum A, Medeiros J. Effect of duration of passive stretch on hip abduction range of motion. J Orthop Sports Phys Ther. 1987;8(8):409-16. doi: 10.2519/jospt.1987.8.8.409.

    PMID: 18797037BACKGROUND
  • Romero-Dapueto C, Mahn J, Cavada G, Daza R, Ulloa V, Antunez M. [Hand grip strength values in normal Chilean subjects]. Rev Med Chil. 2019 Jun;147(6):741-750. doi: 10.4067/S0034-98872019000600741. Spanish.

    PMID: 31859827BACKGROUND
  • Viswas R, Ramachandran R, Korde Anantkumar P. Comparison of effectiveness of supervised exercise program and Cyriax physiotherapy in patients with tennis elbow (lateral epicondylitis): a randomized clinical trial. ScientificWorldJournal. 2012;2012:939645. doi: 10.1100/2012/939645. Epub 2012 May 2.

    PMID: 22629225BACKGROUND

MeSH Terms

Conditions

Tennis ElbowElbow Tendinopathy

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Francisco Javier Martin

    Cadiz University

    STUDY DIRECTOR

Central Study Contacts

Maria Jesus Vinolo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomised, single-blind, multicentre, randomised study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 14, 2022

Study Start

March 30, 2022

Primary Completion

May 3, 2022

Study Completion

May 5, 2023

Last Updated

March 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Publication in journals indexed in the Journal Citation Report (JCR),in the field of Rehabilitation and Physical Medicine and Physiotherapy. 2\. Dissemination of results in national and international Congresses of Rehabilitation and Physical Medicine and Physiotherapy. 3\. Dissemination to the public, press releases and explanatory brochures of the project.

Shared Documents
STUDY PROTOCOL
Time Frame
In two years. In December 2023.
Access Criteria
open file