Humeral Epicondylitis, LateralNCT05021354
Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia
A study testing Dry needling, Topical gel and NSAIDs in people with Humeral Epicondylitis, Lateral, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Humeral Epicondylitis, Lateral
- What is being tested?
- Dry needling, Topical gel and NSAIDs
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with lateral epicondylalgia
Who cannot join
- diagnosed with compressive nerve syndromes with irradiation to the upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).
Read the 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).
- Conditions
- Humeral Epicondylitis, Lateral
- Being tested
- Dry needling, Topical gel, NSAIDs
- Keywords
- Dry needling, Stretching, Eccentric exercise, tennis elbow, humeral epicondylitis, lateral
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
dry needling, stretching and eccentric exercise
Topical gelDevice
aplication of topical gel to the epicondyle
NSAIDsDrug
oral intake of NSAIDs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dry needling |
| topical gel | Active comparator | application of topical gel to the area of pain Receives: Device: Topical gel |
| NSAIDs | Active comparator | oral intake of NSAIDs Receives: Drug: NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionaire Hand 10
score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.
Measured: 1 month
VAS Scale
pain scale, where 0 is the minimum pain and 10 is the maximum pain.
Measured: 1 month
Secondary outcomes (1)
pain concentration measured with algometry
pain when performing static pressures measured with an algometer
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Humeral Epicondylitis, LateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021354
- Sponsor's protocol ID
- 23/08/2021
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27106557Aguilera-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.
PubMed 24975763Dones 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.
PubMed 24589069Cha 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.
PubMed 31040053Lee 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.
PubMed 29706713Bisset 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.
PubMed 26361816George 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.
PubMed 31518778Dong 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.
PubMed 26392595Nishizuka 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.
PubMed 29734897Uygur 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.
PubMed 28828509Sanchez-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.
PubMed 40629912
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT05021354
- Acronym / sponsor ID
- 23/08/2021
- Conditions
- Humeral Epicondylitis, Lateral
- Keywords
- Dry needling, Stretching, Eccentric exercise, tennis elbow, humeral epicondylitis, lateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry needling+eccentric exercises | Experimental | Device: Dry needlingIt 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. |
| topical gel | Active comparator | Device: Topical gelapplication of topical gel to the area of pain |
| NSAIDs | Active comparator | Drug: NSAIDsoral intake of NSAIDs |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed with lateral epicondylalgia
Key exclusion criteria (1 listed)
- diagnosed with compressive nerve syndromes with irradiation to the upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingdry needling, stretching and eccentric exercise | Device | Dry needling+eccentric exercises |
| Topical gelaplication of topical gel to the epicondyle | Device | topical gel |
| NSAIDsoral intake of NSAIDs | Drug | NSAIDs |
Primary outcome
Questionaire Hand 10
Time frame: 1 month
score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.
VAS Scale
Time frame: 1 month
pain scale, where 0 is the minimum pain and 10 is the maximum pain.
1 secondary outcome
pain concentration measured with algometry
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27106557Heales 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.
- BackgroundAguilera-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.
- BackgroundAraya Quintanilla F, Moyano Galvez V. Exercise therapy for lateral epicondylalgia: Systematic review. Rev Soc Esp Dolor 2015;22(6):253-270.
- BackgroundAguilera 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: PubMed 24975763Patel 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.
- Background: PubMed 24589069Dones 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.
- Background: PubMed 31040053Cha 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.
- Background: PubMed 29706713Lee 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 publication: PubMed 26361816Bisset 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 publication: PubMed 31518778George 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 publication: PubMed 26392595Dong 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.
- Results publication: PubMed 29734897Nishizuka 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling, Topical gel and NSAIDs in people with Humeral Epicondylitis, Lateral, run by Universidad Católica de Ávila at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionaire Hand 10 (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05021354, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.