Efficacy of a Stretching Protocol for Lateral Epicondylitis

Epicondylitis Clinical Trial

Official title:

Efficacy of a Whole Upper Limb Stretching Protocol for Lateral Epicondylitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05238090
• Other study ID #: EPITERA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: February 2022
• Source: University of Cadiz
• Contact: Maria Jesus Vinolo
• Phone: 697953671
• Email: mariajesus.vinolo[@]uca.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the applying a stretching protocol to lateral epicondylitis.

Description:

Epicondylitis is one of the most common soft tissue disorders of the locomotor system of the upper limb. Despite the existence of a large number of therapeutic alternatives for this type of injury, no agreed treatment protocol has been found. Some authors even suggest treating the patient from a more global biomechanical perspective.

OBJECTIVES. To evaluate the efficacy of applying a stretching protocol to the entire muscle chain involved in this injury and circumscribed to the entire affected upper limb.

METHODOLOGY. The study will be made up of 40 patients of both genders, randomly distributed in two groups: a control group made up of twenty patients to whom the usual Physiotherapy treatment will be applied, and an experimental group made up of the rest of the subjects, in which a stretching protocol will be applied to the whole upper limb affected and defined for this study. The evaluation process will consist of measuring pain perception using a visual analogue scale (VAS) and grip strength with a dynamometer. These measurements will be performed on all study subjects before starting treatment, at week 4 and week 6.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 5, 2023
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult subjects over 18 years of age.

• Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.

• Patient's prior informed consent for inclusion in the study.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Elbow Tendinopathy
• Epicondylitis
• Epicondylitis of the Elbow
• Epicondylitis, Lateral
• Tendinopathy
• Tennis Elbow

Intervention

Other:
• Passive and active analytical stretching exercises
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.
• Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

Buchbinder R, Green SE, Struijs P. Tennis elbow. BMJ Clin Evid. 2008 May 28;2008. pii: 1117. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Shiri R, Viikari-Juntura E, Varonen H, Heliövaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. Epub 2006 Sep 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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