NCT06494332

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

July 2, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

PreventionEpicaondylalgiaExerciseStretching

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    0 week, 4 week

Secondary Outcomes (3)

  • Hand grip strength

    0 week, 4 week

  • Range of movement

    0 week, 4 week

  • Subjective perception

    0 week, 4 week

Study Arms (2)

Experimental

EXPERIMENTAL

3 weekly sessions (12 sessions in total) of approximately 35 minutes each of exercise and stretching.

Other: Exercise and stretching programe

Control

NO INTERVENTION

No intervention.

Interventions

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.

Experimental

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Hernández Guillén

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Tennis ElbowMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Hernández-Guillén, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

July 1, 2024

Primary Completion

August 31, 2024

Study Completion

September 30, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations