NCT05021354

Brief Summary

Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

August 23, 2021

Last Update Submit

September 11, 2024

Conditions

Humeral Epicondylitis, Lateral

Keywords

Dry needlingStretchingEccentric exercisetennis elbowhumeral epicondylitis, lateral

Outcome Measures

Primary Outcomes (2)

  • Questionaire Hand 10

    score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.

    1 month

  • VAS Scale

    pain scale, where 0 is the minimum pain and 10 is the maximum pain.

    1 month

Secondary Outcomes (1)

  • pain concentration measured with algometry

    10 days

Study Arms (3)

Dry needling+eccentric exercises

EXPERIMENTAL

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.

Device: Dry needling

topical gel

ACTIVE COMPARATOR

application of topical gel to the area of pain

Device: Topical gel

NSAIDs

ACTIVE COMPARATOR

oral intake of NSAIDs

Drug: NSAIDs

Interventions

Dry needlingDEVICE

dry needling, stretching and eccentric exercise

Dry needling+eccentric exercises
Topical gelDEVICE

aplication of topical gel to the epicondyle

topical gel
NSAIDsDRUG

oral intake of NSAIDs

NSAIDs

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with lateral epicondylalgia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (14)

  • 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.

    PMID: 27106557BACKGROUND

  • 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.

    BACKGROUND

  • Araya Quintanilla F, Moyano Galvez V. Exercise therapy for lateral epicondylalgia: Systematic review. Rev Soc Esp Dolor 2015;22(6):253-270.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 24975763BACKGROUND

  • 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.

    PMID: 24589069BACKGROUND

  • 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.

    PMID: 31040053BACKGROUND

  • 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.

    PMID: 29706713BACKGROUND

  • 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.

    PMID: 26361816RESULT

  • 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.

    PMID: 31518778RESULT

  • 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.

    PMID: 26392595RESULT

  • 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.

    PMID: 29734897RESULT

  • 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.

    PMID: 28828509RESULT

  • Sanchez-Mila Z, Abuin-Porras V, Fidalgo-Gomez H, Minguez-Esteban I, Almazan-Polo J, Velazquez-Saornil J. Efficacy of Dry Needling Combined with Eccentric Exercise Versus Oral and Topical NSAID Treatment in Patients with Tennis Elbow: A Randomized Controlled Trial. J Evid Based Integr Med. 2025 Jan-Dec;30:2515690X251355017. doi: 10.1177/2515690X251355017. Epub 2025 Jul 9.

    PMID: 40629912DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Dry NeedlingAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 25, 2021

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)