Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000196448
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
15/02/2016
Date last updated
15/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two exercise protocols for the rotator cuff and scapular stabilizers in patients with subacromial syndrome: a randomized controlled pilot study.
Scientific title
Comparison of two exercise protocols for the rotator cuff and scapular stabilizers in patients with subacromial syndrome, focusing on pain, range of motion and shoulder function.
Secondary ID [1] 287728 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial syndrome 296565 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296826 296826 0 0
Physiotherapy
Musculoskeletal 297736 297736 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sample is divided in 2 groups: group 1 (G1) and group 2 (G2). Both perform eccentric exercise program for rotator cuff, exercises for scapular stabilizers (especially lower trapezius and anterior serratus) and upper trapezius stretch. The materials used are elastic bands and dumbbells.

The main difference between the two groups is the intensity of the exercise accomplished: G1 overcomes the exercise without any pain and G2 performs exercise with pain (never exceeding 40mm according to the Visual Analogue Scale, where 0mm is absence of pain and 100mm is worst pain experienced).

Exercises:
-Eccentric shoulder abductors.
-Eccentric and concentric external and internal shoulder rotators.
-Inferior Glide: isometric exercise (lower trapezius).
-Dynamic Hug (anterior serratus).
-Upper trapezius stretch.

The exercise protocol is performed during 4 weeks, 5 times a week (one session per day from Monday to Friday, and Saturday and Sunday rest). Each patient is scheduled to have 20 sessions during the 4 week exercise period. The format of sessions is individual one-on-one sessions with a physiotherapist. All of them are supervised by physiotherapists of the research team to ensure adherence to treatment and proper performance. Also, the physiotherapists will take track of the patients that follow the treatment each day.

Patients perform 3 sets of 10 repetitions for each abductor and rotator exercise and for the Dynamic Hug. Also, 3 sets of 10 repetitions with 5 seconds of contraction for the Inferior Glide. The rest between sets is twice as long of a set. Finally, the upper trapezius stretch is performed 30 seconds for a total of 3 times.

The sessions take place at health centres of “Hospital de Manises”, Valencia (Spain). Each session will last approximately 40 minutes.
Physiotherapists of the research team perform 2 individual assessments (one-on-one consultation) with each patient: The first assessment before starting the first session, and the other at the end of the 20 sessions.

The variables assessed are shoulder pain (with the Visual Analogue Scale), the shoulder’s active range of motion with the use of a goniometer and shoulder function using the Constant-Murley test.
Intervention code [1] 293327 0
Rehabilitation
Comparator / control treatment
Group 1 is the control active group. The patient perform the same exercises than the other group, but with the maximum load that allows exercise with no pain (Visual Analogue Scale = 0/100mm). If pain appears during exercise the patient must stop immediately and decrease the load using less resistant elastic bands or dumbbells.
Control group
Active

Outcomes
Primary outcome [1] 296971 0
Change in shoulder pain (assessed by 100mm Visual Analogue Scale).
Timepoint [1] 296971 0
Baseline and 4 weeks after intervention commencement.
Primary outcome [2] 296972 0
Change in shoulder’s range of motion (assessed using a goniometer).
Timepoint [2] 296972 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [1] 319785 0
Change in function (assessed using the Constant-Murley Scale).
Timepoint [1] 319785 0
Baseline and 4 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Subjects with medical diagnosis of subacromial syndrome, with painful range of motion during active shoulder elevation.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with rupture of the rotator cuff, fractures in the shoulder complex or shoulder surgery on the affected side within the past three months, frozen shoulder, shoulder prosthesis, fibromyalgia, radiologically verified malignancy, osteoarthritis of the glenohumeral joint and a history of chronic rheumatic or inflammatory disease.

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)
A doctor determines if a subject is eligible for inclusion in the trial and refers patients to rehabilitation. The doctor must not know to which group they belong, since this process is done randomly and is completely in charge the team of physiotherapist. The process randomness is completely private and the patient distribution kept in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A process of simple randomization is used to create the random order for the allocation of patients into different groups: There is a bag with 22 sealed opaque envelopes, 11 envelopes have “group 1” written inside, and 11 envelopes “group 2” and completely mixed inside the bag. When each subject reads and signs the informed consent, a physiotherapist randomly opens a sealed envelope and informs the other group members to which group does this patient belongs.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is a randomized controlled pilot study, so the sample size is established according to other available pilot trials on eccentric training in subacromial syndrome.
This trial is conducted with a final objective of treatment.
The analysed variables are: age, sex, height, weight, shoulder pain pre-intervention and post-intervention, shoulder range of motion pre and post-intervention (flexion, extension, abduction and adduction), shoulder function pre and post- intervention.
The statistical analysis is performed in the SPSS computer:
1. Checking normality of the quantitative variables with the Shapiro-Wilks test.
2. Descriptive statistics. The calculation of mean, standard deviation, median and quartiles.
3. Checking homogeneity of variance of the groups: Student T-test or T-Welch. Mann-Whitney U test. Fisher’s exact test.
4. Comparison of pre and post-intervention outcomes: Student T-test for independent samples and Wilcoxon test.
5. The Student T-test for independent samples and the Mann-Whitney U test are performed to analyse the differences and effectiveness of interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2016
Actual
Date of last participant enrolment
Anticipated
9/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 7511 0
Spain
State/province [1] 7511 0
Valencia

Funding & Sponsors
Funding source category [1] 292675 0
Hospital
Name [1] 292675 0
Hospital de Manises
Country [1] 292675 0
Spain
Primary sponsor type
University
Name
University of Alcala
Address
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid (Spain).
Country
Spain
Secondary sponsor category [1] 291395 0
None
Name [1] 291395 0
None
Address [1] 291395 0
None
Country [1] 291395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294153 0
Comite de Etica de Investigacion y Experimentacion Animal (CEI) de la Universidad de Alcala
Ethics committee address [1] 294153 0
Ethics committee country [1] 294153 0
Spain
Date submitted for ethics approval [1] 294153 0
30/10/2015
Approval date [1] 294153 0
07/01/2016
Ethics approval number [1] 294153 0
CEIM/HU/201533
Ethics committee name [2] 294154 0
Comite Etico de Investigacion Clinica de La Fe
Ethics committee address [2] 294154 0
Ethics committee country [2] 294154 0
Spain
Date submitted for ethics approval [2] 294154 0
08/07/2015
Approval date [2] 294154 0
08/09/2015
Ethics approval number [2] 294154 0
0778

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 719 719 0 0
/AnzctrAttachments/369520-Dictamen_CEIC_LA_FE_08092015.pdf
Attachments [2] 720 720 0 0
/AnzctrAttachments/369520-CEI_Universidad de Alcalá.pdf
Attachments [3] 721 721 0 0
/AnzctrAttachments/369520-AprobacionCIHMA_TFM_EvaVallés.pdf

Contacts
Principal investigator
Name 61138 0
Miss Eva Valles Carrascosa
Address 61138 0
University of Alcala. Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid (Spain)
Country 61138 0
Spain
Phone 61138 0
+34600739536
Fax 61138 0
Email 61138 0
[email protected]
Contact person for public queries
Name 61139 0
Eva Valles Carrascosa
Address 61139 0
University of Alcala. Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid (Spain)
Country 61139 0
Spain
Phone 61139 0
+34600739536
Fax 61139 0
Email 61139 0
[email protected]
Contact person for scientific queries
Name 61140 0
Eva Valles Carrascosa
Address 61140 0
University of Alcala. Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid (Spain)
Country 61140 0
Spain
Phone 61140 0
+34600739536
Fax 61140 0
Email 61140 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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