Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001480471
Ethics application status
Approved
Date submitted
30/09/2016
Date registered
24/10/2016
Date last updated
24/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a motor control program on pain and functionality in patients diagnosed with shoulder impingement syndrome: randomized clinical trial.
Scientific title
Efficacy of a motor control program on pain and functionality in patients diagnosed with shoulder impingement syndrome: randomized clinical trial.
Secondary ID [1] 290236 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement syndrome 300424 0
Condition category
Condition code
Musculoskeletal 300286 300286 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300287 300287 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the intervention group, the participants will have to implement two different kinds of treatment. First of all, they will have to complete a motor control program focused on muscles like medium and lower trapezius and anterior serratus, which are responsible for stabilize the scapula when shoulder makes a movement in the space. In addition, this group will realise also a strengthening program for the rotator cuff muscles. This program consists on working in different movements of the shoulder like flexion, extension, abduction, internal and external rotation using elastic bands to get resistance for these movements. The participants will realise 3 series of each movement with 10 repetitions per serie.

Elastic bands will be used to perform the strengthening program. Different levels of resistance will be used depending on the patient evolution. These levels will be supervised by the therapist. Besides, participants will receive verbal orders from the therapist to implement the motor control program in the correct way.

The professional who will implement the program will be a physiotherapist with more than five years of clinical experience.

The delivery mode will be attendance individually in a physiotherapist consultation. During the intervention, participants will have to sign every attendance session at hospital. This condition will allow the researchers to know the level of attendance in control and intervention group.

The intervention consists of two sessions of 30 minutes per week during eight weeks.
The location will be in a public hospital in Madrid called "Hospital Clinico San Carlos".
Intervention code [1] 296035 0
Rehabilitation
Intervention code [2] 296036 0
Treatment: Other
Comparator / control treatment
Comparator / control treatment: The control group is an active group, they will perform the same strengthening program as the intervention group, with elastic bands for the rotator cuff muscles. This group will realise abduction, flexion, extension, internal and external rotation movements in the shoulder joint, the resistance will be given by the different levels of elastic bands. Different from intervention, control group will not implement a motor control program for the scapula-thoracic joint.

They also will attendance at hospital during eight weeks with two sessions per week too.
Control group
Active

Outcomes
Primary outcome [1] 299785 0
To measure the effect of the application of a motor control program, in addition with a program to strengthen shoulder in pain of patients diagnosed with subacromial syndrome. This outcome will be assessed using a visual analogue scale.
Timepoint [1] 299785 0
For this primary outcome we will realise three timepoints. First of all, at baseline before participants begins the treatment. Secondly when rehabilitation program will be finished, in the last treatment session, and finally a month after the intervention was concluded.
Primary outcome [2] 299835 0
To measure the effect of the application of a motor control program, in addition with a program to strengthen shoulder in functionality of patients diagnosed with subacromial syndrome. This outcome will be measured using DASH questionnaire.
Timepoint [2] 299835 0
For this primary outcome we will realise three timepoints. First of all, at baseline before participants begins the treatment. Secondly when rehabilitation program will be finished, in the last treatment session, and finally a month after the intervention was concluded.
Secondary outcome [1] 328108 0
to assess changes in pressure pain threshold in symptomatic shoulder structures after applying the intervention. This outcome will be assessed using algometry.
Timepoint [1] 328108 0
For this secondary outcome we will realise three timepoints. First of all, at baseline before participants begins the treatment. Secondly when rehabilitation program will be finished, in the last treatment session, and finally a month after the intervention was concluded.
Secondary outcome [2] 328109 0
Proprioception, assessed by Joint Position Sense in the shoulder flexion movement.
Timepoint [2] 328109 0
For this secondary outcome we will realise three timepoints. First of all, at baseline before participants begins the treatment. Secondly when rehabilitation program will be finished, in the last treatment session, and finally a month after the intervention was concluded.

Eligibility
Key inclusion criteria
- diagnosis of shoulder impingement syndrome.
- positive result in 2/3 orthopedic tests (Hawkins, Neer, Yokum)
- inform consent sign from the patient.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Totally rupture or tears of the rotator cuff tendons.
- Patients who had suffered any shoulder surgery

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment outside Australia
Country [1] 8280 0
Spain
State/province [1] 8280 0
Madrid

Funding & Sponsors
Funding source category [1] 294616 0
Hospital
Name [1] 294616 0
Hospital Clinico San Carlos
Country [1] 294616 0
Spain
Funding source category [2] 294617 0
University
Name [2] 294617 0
Universidad de Alcala de Henares
Country [2] 294617 0
Spain
Primary sponsor type
University
Name
Universidad de Alcala de Henares
Address
Plaza san Diego s/n, Alcala de Henares, Madrid, 28805.
Country
Spain
Secondary sponsor category [1] 293479 0
None
Name [1] 293479 0
None
Address [1] 293479 0
None
Country [1] 293479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296057 0
CEIC Hospital Clinico San Carlos
Ethics committee address [1] 296057 0
Calle del doctor Martin Lagos s/n, Madrid, 28040
Ethics committee country [1] 296057 0
Spain
Date submitted for ethics approval [1] 296057 0
15/06/2016
Approval date [1] 296057 0
14/07/2016
Ethics approval number [1] 296057 0
C.P-C.I 16/329

Summary
Brief summary
Title: Efficacy of a motor control program on pain and functionality in patients diagnosed with shoulder impingement syndrome: randomized clinical trial.

Background: pain and functional limitation in the shoulder joint complex, known as impingement syndrome, is one of the great problems for the working population in developed countries and one of the main reasons for medical services. Despite the many efforts by the scientific community in establishing the causes or responsible for generating this syndrome, the reality is that these etiological factors remain unclear, considering that in a high percentage of the patients diagnosed with this syndrome, the cause thereof entity is not known.

Among others, stability and abnormal mobility of the scapula on the rib cage during movements of the upper limb, have been indicated as potential triggers or aggravating causes of subacromial syndrome. Such mobility and stability required in the scapula may be present due to a deficit in the motor control of the lower trapezius muscle, middle trapezius and serratus anterior. In this line, very few studies to date that have guided conservative treatment for this syndrome to control scapular stability and mobility through motor control techniques, comparing the results obtained with other techniques of conservative treatment.

Objectives: To measure the effect of the application of a motor control program, in addition with a program to strengthen shoulder in pain and functionality of patients diagnosed with subacromial syndrome.

Subjects and methodology: to achieve the objectives of the study will be carry out a randomized clinical trial comparing two similar and homogeneous groups at startup. The patients who fulfill the inclusion and exclusion criteria and after reading the newsletter and sign informed consent will enter into the study and randomly form part of the control group (strengthening) or experimental group (strengthening + motor control). The intervention, which consist of 2 classroom (attended) sessions a week, apply over 8 weeks. 3 measurements shall be performed at baseline, at the end of the 8 weeks of treatment and one month after the last treatment session.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69094 0
Dr Gustavo Plaza Manzano
Address 69094 0
Plaza san diego s/n, Alcala de Henares, Madrid, 28805.
Country 69094 0
Spain
Phone 69094 0
+34 653 632 513
Fax 69094 0
Email 69094 0
[email protected]
Contact person for public queries
Name 69095 0
Mr Miguel Angel Gonzalez Martins
Address 69095 0
Calle Pedro Heredia, 25, Madrid, 28027.
Country 69095 0
Spain
Phone 69095 0
+34 655 65 02 00
Fax 69095 0
Email 69095 0
[email protected]
Contact person for scientific queries
Name 69096 0
Mr Eduardo Perez Costa
Address 69096 0
Calle Pintor Velazquez, 22, Alcobendas, Madrid, 28100.
Country 69096 0
Spain
Phone 69096 0
+34 916618213
Fax 69096 0
Email 69096 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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