- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021354
Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia
October 26, 2023 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Methods: LE is a musculoskeletal pain around the lateral epicondyle that may also present with decreased grip strength and/or neuromuscular disorders.
An evidence-based treatment plan of dry needling, stretching and eccentric exercise in the patient with lateral epicondylalgia is established.
It is carried out in two sessions, one session every 10 days and lasts about 45 minutes.
There are three intervention arms: dry needling, atopic gel and NSAIDs, 30 patients in each group (n=90).
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ávila, Spain, 05005
- Universidad Católica de Ávila
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosed with lateral epicondylalgia
Exclusion Criteria:
- diagnosed with compressive nerve syndromes with irradiation to the upper limb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling+eccentric exercises
It is established a plan of treatment base on the evidence for dry needling, eccentric exercise in the patient with lateral epicondylalgia.
This is done in two sessions, one session every 10 days and with a duration of about 45 minutes.
|
dry needling, stretching and eccentric exercise
|
Active Comparator: topical gel
application of topical gel to the area of pain
|
aplication of topical gel to the epicondyle
|
Active Comparator: NSAIDs
oral intake of NSAIDs
|
oral intake of NSAIDs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionaire Hand 10
Time Frame: 1 month
|
score in discomfort hand 0-10.
0 is the lowest score and 10 is the highest score.
|
1 month
|
VAS Scale
Time Frame: 1 month
|
pain scale, where 0 is the minimum pain and 10 is the maximum pain.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain concentration measured with algometry
Time Frame: 10 days
|
pain when performing static pressures measured with an algometer
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee JH, Kim TH, Lim KB. Effects of eccentric control exercise for wrist extensor and shoulder stabilization exercise on the pain and functions of tennis elbow. J Phys Ther Sci. 2018 Apr;30(4):590-594. doi: 10.1589/jpts.30.590. Epub 2018 Apr 20.
- Heales LJ, Bergin MJG, Vicenzino B, Hodges PW. Forearm Muscle Activity in Lateral Epicondylalgia: A Systematic Review with Quantitative Analysis. Sports Med. 2016 Dec;46(12):1833-1845. doi: 10.1007/s40279-016-0539-4.
- Aguilera-Eguía R, Ibacache-Palma A, Ignacia-Ulloa M, Flores-Fernández C, López-Soto LM, López Soto OP. Effectiveness of acupuncture in patients with lateral epicondylalgia: an overview of systematic reviews. Rev Cienc Salud. 2017;15(1):37-48.
- Araya Quintanilla F, Moyano Galvez V. Exercise therapy for lateral epicondylalgia: Systematic review. Rev Soc Esp Dolor 2015;22(6):253-270.
- Aguilera Eguía RA, Zafra Santos EO, Rojas López DK, Saavedra Rozas PA, Cofre Bolados C. Effectiveness of low frequency laser in the treatment of pain in patients with lateral epicondylalgia: An overview of systematic reviews. Rev Soc Esp Dolor 2015; 22(1): 39-47.
- Patel RM, Lynch TS, Amin NH, Calabrese G, Gryzlo SM, Schickendantz MS. The thrower's elbow. Orthop Clin North Am. 2014 Jul;45(3):355-76. doi: 10.1016/j.ocl.2014.03.007.
- Dones VC 3rd, Grimmer K, Thoirs K, Suarez CG, Luker J. The diagnostic validity of musculoskeletal ultrasound in lateral epicondylalgia: a systematic review. BMC Med Imaging. 2014 Mar 3;14:10. doi: 10.1186/1471-2342-14-10.
- Cha YK, Kim SJ, Park NH, Kim JY, Kim JH, Park JY. Magnetic resonance imaging of patients with lateral epicondylitis: Relationship between pain and severity of imaging features in elbow joints. Acta Orthop Traumatol Turc. 2019 Sep;53(5):366-371. doi: 10.1016/j.aott.2019.04.006. Epub 2019 Apr 28.
- Bisset LM, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015 Oct;61(4):174-81. doi: 10.1016/j.jphys.2015.07.015. Epub 2015 Sep 8. No abstract available.
- George CE, Heales LJ, Stanton R, Wintour SA, Kean CO. Sticking to the facts: A systematic review of the effects of therapeutic tape in lateral epicondylalgia. Phys Ther Sport. 2019 Nov;40:117-127. doi: 10.1016/j.ptsp.2019.08.011. Epub 2019 Aug 27.
- Dong W, Goost H, Lin XB, Burger C, Paul C, Wang ZL, Kong FL, Welle K, Jiang ZC, Kabir K. Injection therapies for lateral epicondylalgia: a systematic review and Bayesian network meta-analysis. Br J Sports Med. 2016 Aug;50(15):900-8. doi: 10.1136/bjsports-2014-094387. Epub 2015 Sep 21.
- Nishizuka T, Iwatsuki K, Kurimoto S, Yamamoto M, Onishi T, Hirata H. Favorable Responsiveness of the Hand10 Questionnaire to Assess Treatment Outcomes for Lateral Epicondylitis. J Hand Surg Asian Pac Vol. 2018 Jun;23(2):205-209. doi: 10.1142/S2424835518500212.
- Uygur E, Aktas B, Ozkut A, Erinc S, Yilmazoglu EG. Dry needling in lateral epicondylitis: a prospective controlled study. Int Orthop. 2017 Nov;41(11):2321-2325. doi: 10.1007/s00264-017-3604-1. Epub 2017 Aug 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
September 30, 2023
Study Completion (Estimated)
October 30, 2023
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23/08/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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