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Trial registered on ANZCTR
Registration number
ACTRN12624000798561p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of the effectiveness of an exercise program in CrossFit athletes with shoulder pain
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Scientific title
Comparison of the effectiveness of an individualized exercise program in overhead sports athletes with symptoms of unilateral shoulder impingement syndrome: a randomized clinical trial.
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Secondary ID [1]
312138
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
SPAD
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement
333957
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Shoulder pain
333958
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Condition category
Condition code
Physical Medicine / Rehabilitation
330456
330456
0
0
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Physiotherapy
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Musculoskeletal
330629
330629
0
0
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Other muscular and skeletal disorders
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Injuries and Accidents
330630
330630
0
0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Carrying out the intervention during the 6-week period, supervised by athletic coach in the CrossFit box in one-on-one at the start of the trainning session.
The specific intervention program is composed of 7 exercises (Overhead squat with stick, Overhead squat with bar, Y-wall press, Overhead squat with band, scapular push-ups, wall slide with band, gymnastic bear crawl) performed during the warm-up time. Exercises will be realize at a RPE of 4/10. A total of 18 sessions will be carried out, in the seven exercises 2 series of 8 repetitions will be performed with 60 seconds of rest between exercises and a minute and a half between series, three days a week for 6 weeks.
Previously, both groups will receive advice regarding pain control, posture, movement control and will have the exercises explained in a video support for the control group and for the specific exercise group. In addition, they will be sensitized to adherence to treatment and compliance with home sessions. Adherence will be assessed by a cheklist attendance after each session.
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Intervention code [1]
328572
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Prevention
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Intervention code [2]
328573
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Rehabilitation
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Comparator / control treatment
The stability intervention program consists of four home therapeutic scapular strength and control exercises for the shoulder joint complex based on other protocols of ER, horizontal abduction in lateral and prone decubitus, and shoulder extension in prone position. Exercises will be realize at a RPE of 4/10. A total of 18 sessions will be carried out, in the four exercises 3 series of 10 repetitions will be performed with 60 seconds of rest between exercises and a minute and a half between series, three days a week for 6 weeks. Exercises will be supervised by athletic coach in the CrossFit box in one-on-one at the start of the trainning session. Adherence will be assessed by a cheklist attendance after each session.
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Control group
Active
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Outcomes
Primary outcome [1]
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It's a composite primary outcome. Ratios of maximum isometric force in external rotation/internal rotation from 90º of abduction with 90ºof ER.
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Assessment method [1]
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The subject will be in a sitting position in a chair with a backrest, fixing the elbow and shoulder in a position of 90º abduction and 90º ER. The dynamometer will be placed on the dorsal region of the forearm 2 cm from the styloid process of the ulna. For isometric force ratios, the subject will perform a maximum voluntary force for 5 seconds
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Timepoint [1]
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Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
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Primary outcome [2]
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It's a composite primary outcome: Active range of motion in external rotation, internal rotation and total active range of motion
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Assessment method [2]
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For the ROM measurement, the subject will be in a supine position with 90º of abduction (ABD) of the shoulder, 90º of elbow flexion and a wrist in a neutral position, while stabilizing the scapula to avoid any type of accessory movement.
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Timepoint [2]
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Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
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Primary outcome [3]
338227
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Force-velocity profile
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Assessment method [3]
338227
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The subject will be in a sitting position with the aim of limiting the impact of the lower limbs. With a weight in hand, the subject will perform a one-handed shoulder press at maximum speed. The selected loads will be 20%, 30%, 40% and 50% of body weight in a random order. There will be 3 repetitions for the light loads and 2 for the heavier ones with 10 seconds between each repetition and 3 minutes between each series. It will be measured Peak force (F0) (N and N.kg),
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Timepoint [3]
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Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
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Secondary outcome [1]
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Shoulder pain intensity
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Assessment method [1]
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Numerical pain scale (0 = no pain; to 10 = maximum pain)
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Timepoint [1]
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Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention
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Secondary outcome [2]
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It's a composite secondary outcome: Acute workload and chronic workload
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Assessment method [2]
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Numerical scale of perceived sense of exertion post session (sRPE) (0= very light; to 10 =extenuating) Training time (min)
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Timepoint [2]
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Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention
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Secondary outcome [3]
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Functional variables
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Assessment method [3]
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DASH (Disability of Arm, Shoulder, and Hand): This is a 30-question questionnaire, made up of 21 related to daily activities, followed by 3 about social relationships and, finally, 6 questions about symptoms. Higher DASH scores indicate a higher level of disability and severity, while lower scores indicate a lower level of disability (0 = no disability; 100 = most severe disability)
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Timepoint [3]
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Baseline, 6 weeks and 12 weeks post-intervention
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Secondary outcome [4]
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Force-velocity profile
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Assessment method [4]
436340
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The subject will be in a sitting position with the aim of limiting the impact of the lower limbs. With a weight in hand, the subject will perform a one-handed shoulder press at maximum speed. The selected loads will be 20%, 30%, 40% and 50% of body weight in a random order. There will be 3 repetitions for the light loads and 2 for the heavier ones with 10 seconds between each repetition and 3 minutes between each series. It will be measured Peak velocity (V0) (m.s-1).
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Timepoint [4]
436340
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Baseline, 6 weeks and 12 weeks post-intervention
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Secondary outcome [5]
436341
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Force-velocity profile
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Assessment method [5]
436341
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The subject will be in a sitting position with the aim of limiting the impact of the lower limbs. With a weight in hand, the subject will perform a one-handed shoulder press at maximum speed. The selected loads will be 20%, 30%, 40% and 50% of body weight in a random order. There will be 3 repetitions for the light loads and 2 for the heavier ones with 10 seconds between each repetition and 3 minutes between each series. It will be measured Slope of force-velocity relationship (Sfv) (N.s/m and N.s/m.kg).
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Timepoint [5]
436341
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Baseline, 6 weeks and 12 weeks post-intervention
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Eligibility
Key inclusion criteria
- Men and women.
- Between 18-40 years.
- Shoulder pain lasting at least 3 months.
- At least 2 positive tests out of 5, according to the diagnostic criteria for shoulder impingement
- Subjects who practice CrossFit®.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of surgical interventions (History of fracture of the clavicle, scapula and/or humerus; glenohumeral arthritis; inflammatory arthritis; adhesive capsulitis), congenital disorders already diagnosed that may affect the shoulder joint complex, rotator cuff tendinopathy, partial-total tears of the rotator cuff and signs of glenohumeral instability.
- Currently carrying out physiotherapy treatment.
- Evidence of structural injury in structures of the shoulder joint complex and in tendon structures such as partial or complete ruptures of rotator cuff tendons.
- Metabolic, neurological, autoimmune or cardiovascular diseases that may affect the shoulder region.
- Inability to understand the oral and written language of the study protocol, as well as cognitive disorders.
- Taking analgesic or anti-inflammatory medication a week prior to the measurement or during the intervention.
- Participants who present a moderate-intense level of physical activity according to the IPAQ questionnaire.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sample of this study will be randomized in a 1:1 ratio through the Research Randomizer computer service (Research Randomizer (Version 4.0) [Computer software]) based on a randomization sequence that will be concealed using sequentially closed, opaque, and numbered to study groups
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/09/2024
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Actual
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Date of last participant enrolment
Anticipated
27/12/2024
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Actual
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Date of last data collection
Anticipated
28/03/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26303
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Spain
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State/province [1]
26303
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Madrid
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Universidad Europea de MAdrid
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Address [1]
316499
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Country [1]
316499
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Spain
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Primary sponsor type
University
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Name
Universidad Europea de Madrid
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Address
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Country
Spain
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Secondary sponsor category [1]
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None
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Name [1]
318675
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Address [1]
318675
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Country [1]
318675
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315291
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Ethics Committee for Research on Medicinal Products of the Hospital Clínico San Carlos
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Ethics committee address [1]
315291
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HOSPITAL CLÍNICO SAN CARLOS - Comité Ético de Investigación Clínica - Puerta G – 4ª Norte - C/ Profesor Martín Lagos s/n 28040-Madrid - Spain
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Ethics committee country [1]
315291
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Spain
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Date submitted for ethics approval [1]
315291
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29/05/2024
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Approval date [1]
315291
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Ethics approval number [1]
315291
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Summary
Brief summary
Th principal objective is to compare the effect of a specific exercise program versus a scapular stability exercise program on shoulder functionality in athletes who practice CrossFit® with symptoms of unilateral shoulder impingement syndrome at 6 and 12 weeks. Secondary objectives are: - Compare the effect of a specific exercise program versus a scapular stability exercise program on isometric shoulder muscle strength in athletes who practice CrossFit® with symptoms of unilateral shoulder impingement syndrome at 6 and 12 weeks. . - Compare the effect of a specific exercise program versus a stability exercise program on shoulder range of motion in athletes who practice CrossFit® with symptoms of unilateral shoulder impingement syndrome at 6 and 12 weeks. - Compare the effect of a specific exercise program versus a scapular stability exercise program on the shoulder strength/speed profile variables in athletes who practice CrossFit® with symptoms of unilateral shoulder impingement syndrome at 6 and 12 weeks. - Compare the effect of varying the training load on pain in the shoulder region in athletes who practice CrossFit® with symptoms of unilateral shoulder impingement syndrome at 6 and 12 weeks.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Fabien Guérineau
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Address
134246
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Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
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Country
134246
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Spain
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Phone
134246
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+34644281297
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Fax
134246
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Email
134246
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[email protected]
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Contact person for public queries
Name
134247
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Fabien Guérineau
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Address
134247
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Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
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Country
134247
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Spain
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Phone
134247
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+34644281297
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Fax
134247
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Email
134247
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[email protected]
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Contact person for scientific queries
Name
134248
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Fabien Guérineau
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Address
134248
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Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
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Country
134248
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Spain
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Phone
134248
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+34644281297
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Fax
134248
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Email
134248
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Age, height, weight
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When will data be available (start and end dates)?
Immediately after publication and for 5 years following publication
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Available to whom?
Methodologically sound proposal
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Available for what types of analyses?
only to achieve the aims in the approved proposal
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How or where can data be obtained?
By emailing the principal investigator (
[email protected]
) and reaserchgate.net
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
22391
Study protocol
[email protected]
22392
Ethical approval
[email protected]
22393
Informed consent form
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF