ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

SPAD

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Shoulder impingement

Shoulder pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

Prevention

Intervention code [2]

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]

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]

Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention

Primary outcome [2]

It's a composite primary outcome: Active range of motion in external rotation, internal rotation and total active range of motion

Timepoint [2]

Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention

Primary outcome [3]

Force-velocity profile

Timepoint [3]

Baseline, 6 weeks (primary endpoint) and 12 weeks post-intervention

Secondary outcome [1]

Shoulder pain intensity

Timepoint [1]

Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention

Secondary outcome [2]

It's a composite secondary outcome: Acute workload and chronic workload

Timepoint [2]

Baseline, after each session of the intervention program, 6 weeks and 12 weeks post-intervention

Secondary outcome [3]

Functional variables

Timepoint [3]

Baseline, 6 weeks and 12 weeks post-intervention

Secondary outcome [4]

Force-velocity profile

Timepoint [4]

Baseline, 6 weeks and 12 weeks post-intervention

Secondary outcome [5]

Force-velocity profile

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Madrid

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad Europea de MAdrid

Address [1]

Country [1]

Spain

Primary sponsor type

University

Name

Universidad Europea de Madrid

Address

Country

Spain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Ethics Committee for Research on Medicinal Products of the Hospital Clínico San Carlos

Ethics committee address [1]

HOSPITAL CLÍNICO SAN CARLOS - Comité Ético de Investigación Clínica - Puerta G – 4ª Norte - C/ Profesor Martín Lagos s/n 28040-Madrid - Spain

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

29/05/2024

Approval date [1]

Ethics approval number [1]

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Fabien Guérineau

Address

Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670

Country

Spain

Phone

+34644281297

Fax

fabien.guerineau@universidadeuropea.es

Contact person for public queries

Name

Fabien Guérineau

Address

Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670

Country

Spain

Phone

+34644281297

Fax

fabien.guerineau@universidadeuropea.es

Contact person for scientific queries

Name

Fabien Guérineau

Address

Fabien Guerineau. Universidad Europea de Madrid. Facultad of Sports Science. Departamento de Fisioterapia. C/Tajo S/N, Villaviciosa de Odón, Madrid, 28670

Country

Spain

Phone

+34644281297

Fax

fabien.guerineau@universidadeuropea.es

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 (fabien.guerineau@universidadeuropea.es) and reaserchgate.net

What supporting documents are/will be available?

Doc. No.	Type	Email
22391	Study protocol	fabien.guerineau@universidadeuropea.es
22392	Ethical approval	fabien.guerineau@universidadeuropea.es
22393	Informed consent form	fabien.guerineau@universidadeuropea.es

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.

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