Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12612000967886
Ethics application status
Approved
Date submitted
7/09/2012
Date registered
10/09/2012
Date last updated
10/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of mental training on shoulder impingement syndrome
Scientific title
Does motor imagery rehabilitation (compared to classical rehabilitation) reduce pain and enhance mobility in patients suffering from a stage II shoulder impingement syndrome?
Secondary ID [1] 281184 0
Nil
Universal Trial Number (UTN)
U1111-1134-3714
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Impingement Syndrome 287360 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287689 287689 0 0
Physiotherapy
Musculoskeletal 287699 287699 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants underwent the same physical therapy treatment. They received 10 individual sessions of physical therapy of 1 hour each, scheduled 3 times per week.
In the experimental group we added motor imagery exercises into classical physical therapy sessions, during rest time between two sets of actual exercises. Practically, participants from our experimental group were requested to imagine the same movement that was actually performed beforehand. The control group was subjected to a period of neutral activities during equivalent time, without performing motor imagery at all. Accordingly, they spent the same amount of time to discuss with the experimenter of world news not related to their illness. The whole session lasted 1 hour including 45 minutes for physical therapy and 15 minutes for MI or discussion.
Intervention code [1] 285642 0
Rehabilitation
Intervention code [2] 285643 0
Treatment: Other
Intervention code [3] 285651 0
Prevention
Comparator / control treatment
Conventional physical therapy started by application of ultrasound on the painful points during 5 minutes. Then, in order to relieve pain and increase motion, the pendulum exercise was carried out. Participants were then given strengthening active exercises with and without weights. The 6 main shoulder movements were systematically performed (flexion, extension, abduction, adduction, medial and lateral rotations). These same movements were then carried out by the physiotherapist during passive exercises in order to increase range of motion. At the end of each session, the participants were administered cryotherapy during 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287937 0
Shoulder general functional assessment: Constant Score
Timepoint [1] 287937 0
Pre-test: at the beginning of the program before the 1st physiotherpy session
Post-test: 1 month later after the 10th physiotherapy session
Primary outcome [2] 287938 0
Shoulder range of motion: assessed using a goniometer
Timepoint [2] 287938 0
Pre-test: at the 1st physiotherpy session
Post-test: 1 month later after the 10th physiotherapy session
Primary outcome [3] 287939 0
Pain: assessed using a Horizontal Visual Analog pain Scale (H-VAS)
Timepoint [3] 287939 0
Pre-test: at the 1st physiotherpy session
Post-test: 1 month later after the 10th physiotherapy session
Secondary outcome [1] 299083 0
Nil
Timepoint [1] 299083 0
Nil

Eligibility
Key inclusion criteria
Stage II shoulder impingement syndrome

Movement Imagery Questionnaire (MIQ-R): 2 standard deviations above or below the mean
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with fractures, tendon ruptures, and impaired motor functions due to a nerve lesion or pre-existent upper-extremity disorders.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation: Minimisation method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 4535 0
Lebanon
State/province [1] 4535 0
Country [2] 4536 0
France
State/province [2] 4536 0
Lyon

Funding & Sponsors
Funding source category [1] 285959 0
Self funded/Unfunded
Name [1] 285959 0
N/A
Country [1] 285959 0
Primary sponsor type
University
Name
CRIS-Lyon1 University
Address
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
Country
France
Secondary sponsor category [1] 284783 0
Hospital
Name [1] 284783 0
University College Hospital Notre-Dame de Secours
Address [1] 284783 0
Jbeil - Lebanon

BP 3
Country [1] 284783 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287993 0
Lyon 1 University ethic committee
Ethics committee address [1] 287993 0
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
Ethics committee country [1] 287993 0
Date submitted for ethics approval [1] 287993 0
16/05/2011
Approval date [1] 287993 0
01/09/2011
Ethics approval number [1] 287993 0
N/A

Summary
Brief summary
Motor imagery (MI) is the mental process by which an individual covertly rehearses a motor sequence without any motor output. MI has been used as a complementary therapeutic tool in rehabilitation for motor recovery. Here we investigated the use of MI as a possible preventive tool in the rehabilitation of stage II shoulder impingement syndrome. Shoulder functional assessment, range of motion, and pain will be measured before and after a classical Vs a MI intervention. Better mobility and less pain are expected in the MI group. That might contribute to postpone or even protect from passing to stage III that may require surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34681 0
Address 34681 0
Country 34681 0
Phone 34681 0
Fax 34681 0
Email 34681 0
Contact person for public queries
Name 17928 0
Nady Hoyek
Address 17928 0
Centre de Recherche et d'Innovation sur le Sport - CRIS
Laboratoire de la Performance Motrice, Mentale et du Materiel (P3M)
Universite Claude Bernard - Lyon I - UFR STAPS
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
Country 17928 0
France
Phone 17928 0
+33 (0)4 72 43 16 25
Fax 17928 0
+33 (0)4 72 44 80 10
Email 17928 0
[email protected]
Contact person for scientific queries
Name 8856 0
Nady Hoyek
Address 8856 0
Centre de Recherche et d'Innovation sur le Sport - CRIS
Laboratoire de la Performance Motrice, Mentale et du Materiel (P3M)
Universite Claude Bernard - Lyon I - UFR STAPS
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
Country 8856 0
France
Phone 8856 0
+33 (0)4 72 43 16 25
Fax 8856 0
+33 (0)4 72 44 80 10
Email 8856 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.