TendinopathyNCT03996928
Eccentric Exercise in Epicondylitis
A study testing Exercise in people with Tendinopathy, run by Andaluz Health Service at 1 site in Spain.
Trial summary
There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 1 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old
- Epicondylosis of three or more months of evolution.
- Acceptance of the voluntary participation in the study and signature of the informed consent.
Who cannot join
- Generalized musculoskeletal pain.
- Rheumatological affections involving of the upper limb.
- Cervicobrachialgia.
- Previous trauma in upper limb.
- Neurological or other pathology that may interfere with the function of the upper limb.
- Being out of work or in litigation due to the pathology of the upper limb.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Antonio Oya Casero
Jaén, 23003
JUAN ALFONSO ANDRADE, +34 953 00 80 40, juanalfonsoandrade@gmail.com
MANOLO MADERA
About this study
Official title: Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient
There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. However, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist.
A randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.
Read the detailed description
The main objective of this study is:
To compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet.
The specific objectives of this study are:
Compare the effectiveness of the above-cited approaches in terms of pain Compare the effectiveness of the above-cited approaches in terms of function Compare the effectiveness of the above-cited approaches in terms of satisfaction
- Conditions
- Tendinopathy
- Being tested
- Exercise
- Keywords
- Epicondylitis, Tennis elbow, Eccentric exercise
- Medical subject headings
- Tendinopathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Eccentric exercise by physiotherapist | Experimental | A physiotherapist will apply (in this order) a plan of stretching exercises, warm-up exercises and eccentric exercises of epicondylar muscle,according to a program of 10 sessions of 20 minutes each, during two weeks.
Before exercise, ultrasounds will be applied at intensity of 0.1 wat/cm2, which is considered as a placebo, in order to achieve greater adherence and monitor the treatment. Receives: Other: Exercise |
| Illustrated booklet | Active comparator | A physiotherapist will train the patient an exercise plan equivalent to the one above explained with the help of illustrations. Now, in order to achieve palmar flexion at the same time the patients will contract their epicondylar muscles (the eccentric effect), and elastic band is used. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain
The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters.
A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.
Measured: At two weeks
Visual analogue scale of pain
The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters.
A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.
Measured: Three months
Quick-Dash
At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH.
The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.
Measured: At two weeks
Quick-Dash
At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH.
The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.
Measured: Three months
Satisfaction questionnaire
A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers:
- Very satisfied
- Satisfied
- Neither satisfied nor unsatisfied
- Unsatisfied
- Very unsatisfied
Measured: At two weeks
Satisfaction questionnaire
A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers:
- Very satisfied
- Satisfied
- Neither satisfied nor unsatisfied
- Unsatisfied
- Very unsatisfied
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jan 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies 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
- Single blind randomized controlled trial INDEPENDENT VARIABLES Age, Sex, Work activity (referred to a superior member): intense -including, among other kind of activities, keyboards users and housewives-light. Basal pain according to visual analogue scale (VAS) of 100 mm. Baseline disability according to the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand), which is self-administered. DEPENDENT VARIABLES Pain according to the aforementioned scale just after treatment (2 weeks) and at 3 months. Disability according to the aforementioned questionnaire just after the treatment (2 weeks) and at three months. Satisfaction with the treatment right after it (2 weeks) and at three months. A Likert scale of five points ( very satisfied, satisfied, neither satisfied nor unsatisfied, very unsatisfied) will be used. Co-interventions (Systemic and/or topical route drugs, physiotherapy modalities received outside the system, use of orthoses).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andaluz Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ANTONIO OYA CASERO, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996928
- Sponsor's protocol ID
- OYA-EXC-2019-1
- Status last verified
- Jun 2019
- First submitted
- 22 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.
PubMed 26303397Abate M, Silbernagel KG, Siljeholm C, Di Iorio A, De Amicis D, Salini V, Werner S, Paganelli R. Pathogenesis of tendinopathies: inflammation or degeneration? Arthritis Res Ther. 2009;11(3):235. doi: 10.1186/ar2723. Epub 2009 Jun 30.
PubMed 19591655Nagrale AV, Herd CR, Ganvir S, Ramteke G. Cyriax physiotherapy versus phonophoresis with supervised exercise in subjects with lateral epicondylalgia: a randomized clinical trial. J Man Manip Ther. 2009;17(3):171-8. doi: 10.1179/jmt.2009.17.3.171.
PubMed 20046624Murgia A, Harwin W, Prakoonwit S, Brownlow H. Preliminary observations on the presence of sustained tendon strain and eccentric contractions of the wrist extensors during a common manual task: implications for lateral epicondylitis. Med Eng Phys. 2011 Jul;33(6):793-7. doi: 10.1016/j.medengphy.2011.02.002. Epub 2011 Mar 16.
PubMed 21414830Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. doi: 10.1177/230949901502300101.
PubMed 25920633Jindal N, Gaury Y, Banshiwal RC, Lamoria R, Bachhal V. Comparison of short term results of single injection of autologous blood and steroid injection in tennis elbow: a prospective study. J Orthop Surg Res. 2013 Apr 27;8:10. doi: 10.1186/1749-799X-8-10.
PubMed 23621906Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
PubMed 17910298Viola L. A critical review of the current conservative therapies for tennis elbow (lateral epicondylitis). Australas Chiropr Osteopathy. 1998 Jul;7(2):53-67.
PubMed 17987156Bisset LM, Collins NJ, Offord SS. Immediate effects of 2 types of braces on pain and grip strength in people with lateral epicondylalgia: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):120-8. doi: 10.2519/jospt.2014.4744. Epub 2014 Jan 9.
PubMed 24405258Speed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. Br J Sports Med. 2014 Nov;48(21):1538-42. doi: 10.1136/bjsports-2012-091961. Epub 2013 Aug 5.
PubMed 23918444Olaussen M, Holmedal O, Mdala I, Brage S, Lindbaek M. Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial. BMC Musculoskelet Disord. 2015 May 20;16:122. doi: 10.1186/s12891-015-0582-6.
PubMed 25989985Cullinane FL, Boocock MG, Trevelyan FC. Is eccentric exercise an effective treatment for lateral epicondylitis? A systematic review. Clin Rehabil. 2014 Jan;28(1):3-19. doi: 10.1177/0269215513491974. Epub 2013 Jul 23.
PubMed 23881334Raman J, MacDermid JC, Grewal R. Effectiveness of different methods of resistance exercises in lateral epicondylosis--a systematic review. J Hand Ther. 2012 Jan-Mar;25(1):5-25; quiz 26. doi: 10.1016/j.jht.2011.09.001. Epub 2011 Nov 9.
PubMed 22075055Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy). Clin Rehabil. 2014 Sep;28(9):862-72. doi: 10.1177/0269215514527595. Epub 2014 Mar 14.
PubMed 24634444Soderberg J, Grooten WJ, Ang BO. Effects of eccentric training on hand strength in subjects with lateral epicondylalgia: a randomized-controlled trial. Scand J Med Sci Sports. 2012 Dec;22(6):797-803. doi: 10.1111/j.1600-0838.2011.01317.x. Epub 2011 Apr 18.
PubMed 21496112
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Exercise in Epicondylitis: Direct Application By Physical Therapist Vs Self-Application By Patient
- ClinicalTrials.gov ID
- NCT03996928
- Acronym / sponsor ID
- OYA-EXC-2019-1
- Conditions
- Tendinopathy
- Keywords
- Epicondylitis, Tennis elbow, Eccentric exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andaluz Health ServiceOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 25 Jun 2019 (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.
There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. However, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist.
A randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.
Detailed description
The main objective of this study is:
To compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet.
The specific objectives of this study are:
Compare the effectiveness of the above-cited approaches in terms of pain Compare the effectiveness of the above-cited approaches in terms of function Compare the effectiveness of the above-cited approaches in terms of satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single blind randomized controlled trial INDEPENDENT VARIABLES Age, Sex, Work activity (referred to a superior member): intense -including, among other kind of activities, keyboards users and housewives-light. Basal pain according to visual analogue scale (VAS) of 100 mm. Baseline disability according to the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand), which is self-administered. DEPENDENT VARIABLES Pain according to the aforementioned scale just after treatment (2 weeks) and at 3 months. Disability according to the aforementioned questionnaire just after the treatment (2 weeks) and at three months. Satisfaction with the treatment right after it (2 weeks) and at three months. A Likert scale of five points ( very satisfied, satisfied, neither satisfied nor unsatisfied, very unsatisfied) will be used. Co-interventions (Systemic and/or topical route drugs, physiotherapy modalities received outside the system, use of orthoses).
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise by physiotherapist | Experimental | Other: ExerciseA physiotherapist will apply (in this order) a plan of stretching exercises, warm-up exercises and eccentric exercises of epicondylar muscle,according to a program of 10 sessions of 20 minutes each, during two weeks. Before exercise, ultrasounds will be applied at intensity of 0.1 wat/cm2, which is considered as a placebo, in order to achieve greater adherence and monitor the treatment. |
| Illustrated booklet | Active comparator | Other: ExerciseA physiotherapist will train the patient an exercise plan equivalent to the one above explained with the help of illustrations. Now, in order to achieve palmar flexion at the same time the patients will contract their epicondylar muscles (the eccentric effect), and elastic band is used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years old
- Epicondylosis of three or more months of evolution.
- Acceptance of the voluntary participation in the study and signature of the informed consent.
Key exclusion criteria (6 listed)
- Generalized musculoskeletal pain.
- Rheumatological affections involving of the upper limb.
- Cervicobrachialgia.
- Previous trauma in upper limb.
- Neurological or other pathology that may interfere with the function of 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 |
|---|---|---|
| Exercise | Other | Eccentric exercise by physiotherapist, Illustrated booklet |
Primary outcome
Visual analogue scale of pain
Time frame: At two weeks
The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.
Visual analogue scale of pain
Time frame: Three months
The Visual Analogue Scale (VAS) quantifies of pain described by the patient with maximum reproducibility among observers. It consists of a 10-centimeter horizontal line, at the ends of which the extreme expressions of a symptom are marked: no pain on the left wiht a score 0, and the highest possible pain on the right wiht a score 10. The patient is asked to mark the point that indicates the intensity in the line and is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. A value lower than 4 in the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.
Quick-Dash
Time frame: At two weeks
At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH. The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.
Quick-Dash
Time frame: Three months
At least 10 of the 11 questions must be completed to calculate the score Disability / Symptom of Quick DASH. The assigned values for all the complete answers are summed and averaged, giving as a result, a score based on five. This value is then taken to a score based on 100 subtracting 1 and multiplying it by 25. A higher score greater disability.
Satisfaction questionnaire
Time frame: At two weeks
A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers: 1. Very satisfied 2. Satisfied 3. Neither satisfied nor unsatisfied 4. Unsatisfied 5. Very unsatisfied
Satisfaction questionnaire
Time frame: Three months
A survey will be carried out to find out what the patient has perceived by asking a question about his satisfaction with the treatment received, choosing one of the following answers: 1. Very satisfied 2. Satisfied 3. Neither satisfied nor unsatisfied 4. Unsatisfied 5. Very unsatisfied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Background: PubMed 26303397Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.
- Background: PubMed 19591655Abate M, Silbernagel KG, Siljeholm C, Di Iorio A, De Amicis D, Salini V, Werner S, Paganelli R. Pathogenesis of tendinopathies: inflammation or degeneration? Arthritis Res Ther. 2009;11(3):235. doi: 10.1186/ar2723. Epub 2009 Jun 30.
- Background: PubMed 20046624Nagrale AV, Herd CR, Ganvir S, Ramteke G. Cyriax physiotherapy versus phonophoresis with supervised exercise in subjects with lateral epicondylalgia: a randomized clinical trial. J Man Manip Ther. 2009;17(3):171-8. doi: 10.1179/jmt.2009.17.3.171.
- Background: PubMed 21414830Murgia A, Harwin W, Prakoonwit S, Brownlow H. Preliminary observations on the presence of sustained tendon strain and eccentric contractions of the wrist extensors during a common manual task: implications for lateral epicondylitis. Med Eng Phys. 2011 Jul;33(6):793-7. doi: 10.1016/j.medengphy.2011.02.002. Epub 2011 Mar 16.
- Background: PubMed 25920633Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. doi: 10.1177/230949901502300101.
- Background: PubMed 23621906Jindal N, Gaury Y, Banshiwal RC, Lamoria R, Bachhal V. Comparison of short term results of single injection of autologous blood and steroid injection in tennis elbow: a prospective study. J Orthop Surg Res. 2013 Apr 27;8:10. doi: 10.1186/1749-799X-8-10.
- Background: PubMed 17910298Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
- Background: PubMed 17987156Viola L. A critical review of the current conservative therapies for tennis elbow (lateral epicondylitis). Australas Chiropr Osteopathy. 1998 Jul;7(2):53-67.
- Background: PubMed 24405258Bisset LM, Collins NJ, Offord SS. Immediate effects of 2 types of braces on pain and grip strength in people with lateral epicondylalgia: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):120-8. doi: 10.2519/jospt.2014.4744. Epub 2014 Jan 9.
- Background: PubMed 23918444Speed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. Br J Sports Med. 2014 Nov;48(21):1538-42. doi: 10.1136/bjsports-2012-091961. Epub 2013 Aug 5.
- Background: PubMed 25989985Olaussen M, Holmedal O, Mdala I, Brage S, Lindbaek M. Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial. BMC Musculoskelet Disord. 2015 May 20;16:122. doi: 10.1186/s12891-015-0582-6.
- Background: PubMed 23881334Cullinane FL, Boocock MG, Trevelyan FC. Is eccentric exercise an effective treatment for lateral epicondylitis? A systematic review. Clin Rehabil. 2014 Jan;28(1):3-19. doi: 10.1177/0269215513491974. Epub 2013 Jul 23.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Tendinopathy, run by Andaluz Health Service 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 3 inclusion and 6 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 27 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANTONIO OYA (+34953266123, fisyrec@fisyrec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale of pain (time frame: At two weeks). The study lists 6 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 NCT03996928, which also lists 18 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 27 Jun 2019.