Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Secondary ID [1] 312138 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPAD
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement 333957 0
Shoulder pain 333958 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330456 330456 0 0
Physiotherapy
Musculoskeletal 330629 330629 0 0
Other muscular and skeletal disorders
Injuries and Accidents 330630 330630 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328572 0
Prevention
Intervention code [2] 328573 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 338225 0
It's a composite primary outcome. Ratios of maximum isometric force in external rotation/internal rotation from 90º of abduction with 90ºof ER.
Timepoint [1] 338225 0
Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
Primary outcome [2] 338226 0
It's a composite primary outcome: Active range of motion in external rotation, internal rotation and total active range of motion
Timepoint [2] 338226 0
Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
Primary outcome [3] 338227 0
Force-velocity profile
Timepoint [3] 338227 0
Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention
Secondary outcome [1] 435053 0
Shoulder pain intensity
Timepoint [1] 435053 0
Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention
Secondary outcome [2] 435054 0
It's a composite secondary outcome: Acute workload and chronic workload
Timepoint [2] 435054 0
Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention
Secondary outcome [3] 435055 0
Functional variables
Timepoint [3] 435055 0
Baseline, 6 weeks and 12 weeks post-intervention
Secondary outcome [4] 436340 0
Force-velocity profile
Timepoint [4] 436340 0
Baseline, 6 weeks and 12 weeks post-intervention
Secondary outcome [5] 436341 0
Force-velocity profile
Timepoint [5] 436341 0
Baseline, 6 weeks and 12 weeks post-intervention

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®.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
27/12/2024
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26303 0
Spain
State/province [1] 26303 0
Madrid

Funding & Sponsors
Funding source category [1] 316499 0
University
Name [1] 316499 0
Universidad Europea de MAdrid
Country [1] 316499 0
Spain
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 318675 0
None
Name [1] 318675 0
Address [1] 318675 0
Country [1] 318675 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315291 0
Ethics Committee for Research on Medicinal Products of the Hospital Clínico San Carlos
Ethics committee address [1] 315291 0
Ethics committee country [1] 315291 0
Spain
Date submitted for ethics approval [1] 315291 0
29/05/2024
Approval date [1] 315291 0
Ethics approval number [1] 315291 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134246 0
Mr Fabien Guérineau
Address 134246 0
Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
Country 134246 0
Spain
Phone 134246 0
+34644281297
Fax 134246 0
Email 134246 0
[email protected]
Contact person for public queries
Name 134247 0
Fabien Guérineau
Address 134247 0
Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
Country 134247 0
Spain
Phone 134247 0
+34644281297
Fax 134247 0
Email 134247 0
[email protected]
Contact person for scientific queries
Name 134248 0
Fabien Guérineau
Address 134248 0
Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670
Country 134248 0
Spain
Phone 134248 0
+34644281297
Fax 134248 0
Email 134248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, height, weight
When will data be available (start and end dates)?
Immediately after publication and for 5 years following publication
Available to whom?
Methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
By emailing the principal investigator ([email protected]) and reaserchgate.net


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22391Study protocol  [email protected]
22392Ethical approval  [email protected]
22393Informed 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.