Epicondylitis, LateralNCT05238090
Efficacy of a Stretching Protocol for Lateral Epicondylitis
A study testing Passive and active analytical stretching exercises and Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature in people with Epicondylitis, Lateral and Elbow Tendinopathy, run by University of Cadiz.
Trial summary
Evaluation of the applying a stretching protocol to lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Epicondylitis, Lateral, Elbow Tendinopathy, Epicondylitis of the Elbow
- What is being tested?
- Passive and active analytical stretching exercises and Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2022to 5 May 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of a Whole Upper Limb Stretching Protocol for Lateral Epicondylitis
Evaluation of the applying a stretching protocol to lateral epicondylitis.
Read the detailed 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.
- Being tested
- Passive and active analytical stretching exercises, Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
- Keywords
- epicondylitis, Elbow Tendinopathy, stretch, physiotherapy
- Medical subject headings
- Tennis Elbow, Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive and active analytical stretching exercisesOther
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 musculatureOther
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature Receives: Other: Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature |
| Experimental | Experimental | Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet Receives: Other: Passive and active analytical stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1,5 months
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.
Measured: 1,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start30 Mar 2022 (estimated)
- Primary completion3 May 2022 (estimated)
- Study completion5 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, single-blind, multicentre, randomised study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Martin, Study director, Cadiz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238090
- Sponsor's protocol ID
- EPITERA
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in journals indexed in the Journal Citation Report (JCR),in the field of Rehabilitation and Physical Medicine and Physiotherapy. 2\. Dissemination of results in national and international Congresses of Rehabilitation and Physical Medicine and Physiotherapy. 3\. Dissemination to the public, press releases and explanatory brochures of the project.
Publications
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.
PubMed 26122386Sanders 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.
PubMed 25656546Haahr 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. doi: 10.1136/oem.60.5.322.
PubMed 12709516Fathy 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.
PubMed 26435828Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.
PubMed 16968862Greenbaum 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. doi: 10.1302/0301-620x.81b5.9566.
PubMed 10530864Coel 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. doi: 10.2214/ajr.161.5.8273602.
PubMed 8273602Baker 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. doi: 10.1067/mse.2000.108533.
PubMed 11155299Babaei-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.
PubMed 31987565Yelland 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.
PubMed 31679521Reyhan 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.
PubMed 31104005Buchbinder R, Green SE, Struijs P. Tennis elbow. BMJ Clin Evid. 2008 May 28;2008:1117.
PubMed 19450309Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70.
PubMed 1423702Terra 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.
PubMed 26401498Seng 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.
PubMed 26602153
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Whole Upper Limb Stretching Protocol for Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05238090
- Acronym / sponsor ID
- EPITERA
- Keywords
- epicondylitis, Elbow Tendinopathy, stretch, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 30 Mar 2022 (estimated)
- Primary completion
- 3 May 2022 (estimated)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 14 Feb 2022 (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.
Evaluation of the applying a stretching protocol to lateral epicondylitis.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomised, single-blind, multicentre, randomised study.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculatureStatic stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature |
| Experimental | Experimental | Other: Passive and active analytical stretching exercisesPassive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Passive and active analytical stretching exercisesFor 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. | Other | Experimental |
| Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculatureStatic stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature | Other | Control group |
Primary outcome
Elbow Pain
Time frame: 1,5 months
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.
Grip strength
Time frame: 1,5 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 26122386Knutsen 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.
- Background: PubMed 25656546Sanders 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.
- Background: PubMed 12709516Haahr 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. doi: 10.1136/oem.60.5.322.
- Background: PubMed 26435828Fathy 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.
- Background: PubMed 16968862Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.
- Background: PubMed 10530864Greenbaum 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. doi: 10.1302/0301-620x.81b5.9566.
- Background: PubMed 8273602Coel 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. doi: 10.2214/ajr.161.5.8273602.
- Background: PubMed 11155299Baker 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. doi: 10.1067/mse.2000.108533.
- Background: PubMed 31987565Babaei-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.
- Background: PubMed 31679521Yelland 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.
- Background: PubMed 31104005Reyhan 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.
- Background: PubMed 19450309Buchbinder R, Green SE, Struijs P. Tennis elbow. BMJ Clin Evid. 2008 May 28;2008:1117.
- Individual participant dataSharing planned: Yes. Publication in journals indexed in the Journal Citation Report (JCR),in the field of Rehabilitation and Physical Medicine and Physiotherapy. 2. Dissemination of results in national and international Congresses of Rehabilitation and Physical Medicine and Physiotherapy. 3. Dissemination to the public, press releases and explanatory brochures of the project.
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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.
Francisco Javier Martin study director
Cadiz University
Questions about this trial
What is this clinical trial studying?
A study testing Passive and active analytical stretching exercises and Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature in people with Epicondylitis, Lateral and Elbow Tendinopathy, run by University of Cadiz.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jesus Vinolo (697953671, mariajesus.vinolo@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow Pain (time frame: 1,5 months). 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 NCT05238090, which also lists 20 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 7 Mar 2022.