Epicondylitis, LateralNCT06494332
Prevention of Lateral Epicondylalgia in Handgun Olympic Shooting Athletes
A study testing Exercise and stretching programe in people with Epicondylitis, Lateral, run by University of Valencia at 1 site in Spain.
Trial summary
Lateral epicondylalgia is one of the most common pathologies suffered by Olympic gun shooting athletes. In Spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epicondylitis, Lateral
- What is being tested?
- Exercise and stretching programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2024to 30 Sep 2024
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged >35 years
- Present a risk of suffering from lateral epicondylalgia
- Be in possession of a federation Olympic shooting license
- Practice Olympic shooting with handgun and carry out at least one Olympic shooting training session a week or have participated in the last three months in an official competition
Who cannot join
- Subjects who had serious uncontrolled illnesses
- Who had undergone surgery as a treatment for lateral epicondylalgia
- Who had received treatment for lateral epicondylalgia in the last month or injections of corticosteroids or steroids for this pathology in the last 6 months
- Who had suffered a serious upper limb injury in the last year or present a risk of suffering epicondylalgia due to a cause other than Olympic shooting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Combined With Stretching Program to Prevent Lateral Epicondylalgia in Handgun Olympic Shooting Athletes: a Randomized Controlled Trial
Lateral epicondylalgia is one of the most common pathologies suffered by Olympic gun shooting athletes. In Spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. Preventing these injuries would be fundamental to improve the performance of athletes and to be able to continue adding successes to national honors.
It has also been evidenced that if exercise is combined with stretching, the benefits of physical therapy are increased. High-quality studies have stated that it is not necessary for this exercise protocol combined with stretching to be very prolonged over time, as they affirm that significant improvements can be achieved with only four weeks of exercise.
This study aimed to test the hypothesis that Olympic handgun shooting athletes who perform a four-week multimodal exercise program combined with stretching have a lower risk of suffering from lateral epicondylalgia than athletes who do not perform this program, determining its effectiveness for pain prevention.
- Conditions
- Epicondylitis, Lateral
- Being tested
- Exercise and stretching programe
- Keywords
- Prevention, Epicaondylalgia, Exercise, Stretching
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and stretching programeOther
It consists in: a serie of mobility exercises, which were used as warp-up; the mobility of the elbow, forearm, wrist and fingers of both upper limbs was worked on; and, exercises were performed to strengthen the muscles of both forearms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 3 weekly sessions (12 sessions in total) of approximately 35 minutes each of exercise and stretching. Receives: Other: Exercise and stretching programe |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Algometer
The algometer will be placed on the lateral epicondyle of the humerus and pressure will be applied until the athlete reported feeling pain. 3 measurements will be made on each upper limb and the average will be obtained.
Measured: 0 week, 4 week
Pain - Visual Analogic Scale
The patients will be shown the Visual Analogic Scale (VAS) scale (0-10) on a sheet of paper and will asked to write down how much pain they had in the lateral epicondyle of each upper limb.
Measured: 0 week, 4 week
Secondary outcomes (3)
Hand grip strength
It will be measured using a manual dynamometer, making 3 measurements on each upper limb with the elbow in flexion and 3 measurements with the elbow in extension, and the average of both methods of measurement will be obtained with the aim of achieving the greatest validity.
Measured: 0 week, 4 week
Range of movement
The active range of elbow joint mobility will be measured by goniometry by a highly experienced researcher. The axis of the goniometer will be placed in the elbow joint, the stationary arm will be placed following the humeral diaphysis and the moving arm will be placed following the diaphysis of the radius. 3 measurements will be made on each upper limb and the average will be obtained in order to achieve the greatest validity.
Measured: 0 week, 4 week
Subjective perception
To assess these subjective variables that can affect sporting performance, a questionnaire has been created with responses using a Likert-type scale from 1 to 5 in which the sensation of stopping and the movement of the handgun is assessed, which are essential elements for the execution of a good shot. Specifically, the aspects analyzed in this questionnaire were the perception of stability when raising the weapon, the perception of the arc of movement when aiming, stopping in the correct area and the sensation of wrist lock when stopping.
Measured: 0 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
- Investigators
- David Hernández-Guillén, PT, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494332
- Sponsor's protocol ID
- NB01
- Status last verified
- Oct 2024
- First submitted
- 2 Jul 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Combined With Stretching Program to Prevent Lateral Epicondylalgia in Handgun Olympic Shooting Athletes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06494332
- Acronym / sponsor ID
- NB01
- Conditions
- Epicondylitis, Lateral
- Keywords
- Prevention, Epicaondylalgia, Exercise, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Jul 2024 (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.
Lateral epicondylalgia is one of the most common pathologies suffered by Olympic gun shooting athletes. In Spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. Preventing these injuries would be fundamental to improve the performance of athletes and to be able to continue adding successes to national honors.
It has also been evidenced that if exercise is combined with stretching, the benefits of physical therapy are increased. High-quality studies have stated that it is not necessary for this exercise protocol combined with stretching to be very prolonged over time, as they affirm that significant improvements can be achieved with only four weeks of exercise.
This study aimed to test the hypothesis that Olympic handgun shooting athletes who perform a four-week multimodal exercise program combined with stretching have a lower risk of suffering from lateral epicondylalgia than athletes who do not perform this program, determining its effectiveness for pain prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Exercise and stretching programe3 weekly sessions (12 sessions in total) of approximately 35 minutes each of exercise and stretching. |
| Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged >35 years
- Present a risk of suffering from lateral epicondylalgia
- Be in possession of a federation Olympic shooting license
- Practice Olympic shooting with handgun and carry out at least one Olympic shooting training session a week or have participated in the last three months in an official competition
Key exclusion criteria (4 listed)
- Subjects who had serious uncontrolled illnesses
- Who had undergone surgery as a treatment for lateral epicondylalgia
- Who had received treatment for lateral epicondylalgia in the last month or injections of corticosteroids or steroids for this pathology in the last 6 months
- Who had suffered a serious upper limb injury in the last year or present a risk of suffering epicondylalgia due to a cause other than Olympic shooting
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 and stretching programeIt consists in: a serie of mobility exercises, which were used as warp-up; the mobility of the elbow, forearm, wrist and fingers of both upper limbs was worked on; and, exercises were performed to strengthen the muscles of both forearms. | Other | Experimental |
Primary outcome
Pain - Algometer
Time frame: 0 week, 4 week
The algometer will be placed on the lateral epicondyle of the humerus and pressure will be applied until the athlete reported feeling pain. 3 measurements will be made on each upper limb and the average will be obtained.
Pain - Visual Analogic Scale
Time frame: 0 week, 4 week
The patients will be shown the Visual Analogic Scale (VAS) scale (0-10) on a sheet of paper and will asked to write down how much pain they had in the lateral epicondyle of each upper limb.
3 secondary outcomes
Hand grip strength
Time frame: 0 week, 4 week
Range of movement
Time frame: 0 week, 4 week
Subjective perception
Time frame: 0 week, 4 week
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 18 Oct 2024.
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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.
David Hernández-Guillén, PT, PhD principal investigator
University of Valencia
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 and stretching programe in people with Epicondylitis, Lateral, run by University of Valencia 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 4 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: finished, as of the sponsor's last update on 18 Oct 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?
Pain - Algometer (time frame: 0 week, 4 week). 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?
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 18 Oct 2024.