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Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia

Primary Purpose

Humeral Epicondylitis, Lateral

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Topical gel
NSAIDs
Sponsored by
Universidad Católica de Ávila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Humeral Epicondylitis, Lateral focused on measuring Dry needling, Stretching, Eccentric exercise, tennis elbow, humeral epicondylitis, lateral

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with lateral epicondylalgia

Exclusion Criteria:

  • diagnosed with compressive nerve syndromes with irradiation to the upper limb

Sites / Locations

  • Universidad Católica de Ávila

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dry needling+eccentric exercises

topical gel

NSAIDs

Arm Description

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.

application of topical gel to the area of pain

oral intake of NSAIDs

Outcomes

Primary Outcome Measures

Questionaire Hand 10
score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.
VAS Scale
pain scale, where 0 is the minimum pain and 10 is the maximum pain.

Secondary Outcome Measures

pain concentration measured with algometry
pain when performing static pressures measured with an algometer

Full Information

First Posted
August 23, 2021
Last Updated
October 23, 2023
Sponsor
Universidad Católica de Ávila
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1. Study Identification

Unique Protocol Identification Number
NCT05021354
Brief Title
Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia
Official Title
Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia Case Report
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica de Ávila

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: Test the effectiveness of a physiotherapy treatment in a patient with Lateral epicondylalgia (LE).
Detailed Description
Methods: LE is a musculoskeletal pain around the lateral epicondyle that can also happen with a decrease in grip strength and/or neuromuscular disorders. It is established a plan of treatment base on the evidence for dry needling, stretching and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Epicondylitis, Lateral
Keywords
Dry needling, Stretching, Eccentric exercise, tennis elbow, humeral epicondylitis, lateral

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling+eccentric exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
topical gel
Arm Type
Active Comparator
Arm Description
application of topical gel to the area of pain
Arm Title
NSAIDs
Arm Type
Active Comparator
Arm Description
oral intake of NSAIDs
Intervention Type
Device
Intervention Name(s)
Dry needling
Intervention Description
dry needling, stretching and eccentric exercise
Intervention Type
Device
Intervention Name(s)
Topical gel
Intervention Description
aplication of topical gel to the epicondyle
Intervention Type
Drug
Intervention Name(s)
NSAIDs
Intervention Description
oral intake of NSAIDs
Primary Outcome Measure Information:
Title
Questionaire Hand 10
Description
score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.
Time Frame
1 month
Title
VAS Scale
Description
pain scale, where 0 is the minimum pain and 10 is the maximum pain.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
pain concentration measured with algometry
Description
pain when performing static pressures measured with an algometer
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with lateral epicondylalgia Exclusion Criteria: diagnosed with compressive nerve syndromes with irradiation to the upper limb
Facility Information:
Facility Name
Universidad Católica de Ávila
City
Ávila
ZIP/Postal Code
05005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27106557
Citation
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.
Results Reference
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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.
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Citation
Araya Quintanilla F, Moyano Galvez V. Exercise therapy for lateral epicondylalgia: Systematic review. Rev Soc Esp Dolor 2015;22(6):253-270.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
24975763
Citation
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.
Results Reference
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PubMed Identifier
24589069
Citation
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.
Results Reference
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PubMed Identifier
31040053
Citation
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.
Results Reference
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PubMed Identifier
29706713
Citation
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.
Results Reference
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PubMed Identifier
26361816
Citation
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.
Results Reference
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PubMed Identifier
31518778
Citation
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.
Results Reference
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PubMed Identifier
26392595
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia

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