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Trial registered on ANZCTR


Registration number
ACTRN12615000351516
Ethics application status
Approved
Date submitted
30/03/2015
Date registered
17/04/2015
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Date results provided
6/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain modulation characteristics in people with shoulder impingement and predictors of successful outcomes following physiotherapy treatment
Scientific title
Pain modulation characteristics in people with shoulder impingement and predictors of successful outcomes following physiotherapy treatment
Secondary ID [1] 286451 0
None
Universal Trial Number (UTN)
U1111-1168-8622
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder impingement 294626 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294926 294926 0 0
Physiotherapy
Musculoskeletal 294983 294983 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a 30-minutes session per week for 4 weeks which includes mobilization-with-movement technique, taping for the shoulder and therapeutic exercises to improve scapular control, strengthen scapular stabilizers and rotator cuff muscles and stretch for the anterior and posterior shoulder and scapular elevator. Participants will be informed to perform the therapeutic exercises at home daily which will take around 30 minutes. A physiotherapist with more than 4 years of practice will administer the manual therapy and physiotherapy at the clinic as well as improve the exercises weekly at each appointment. A shoulder diary will be used to monitor adherence to the exercises performed at home and also to monitor pain scores during the 28-days protocol.
Intervention code [1] 291529 0
Rehabilitation
Intervention code [2] 291578 0
Treatment: Other
Comparator / control treatment
Twenty-two age- and gender-matched healthy participants with no history of shoulder or neck pain or injury will also be recruited as control group. The control group will not receive any intervention since they are not shoulder pain patients.
Control group
Active

Outcomes
Primary outcome [1] 294684 0
Conditioned pain modulation (cold pressor test): Pressure pain threshold will be measured using the Somedic Digital Pressure algometer (Somedic AB, Farsta, Sweden) on the shoulder during the ice water bath applied on the opposite hand during 2 minutes.
Timepoint [1] 294684 0
Patient group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements, and 1 assessment post-treatment (week 5).
Healthy group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements.
Primary outcome [2] 294685 0
Thermal pain threshoulds (cold/heat): An electronic sensor (a small device 2 cm3 cube) will be placed over both shoulders and both knees using a velcro strap - TSA 2001-II (MEDOC).
Timepoint [2] 294685 0
Patient group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements, and 1 assessment post-treatment (week 5).
Healthy group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements.
Primary outcome [3] 294686 0
Temporal summation of pain (TS) using the 180 gr von Frey filament (North Coast Medical, San Jose, California) over both shoulder and both knees. Perceived pain intensity (in a 0-100 numerical rating scale) of a single pinprick stimulus will be compared with that of a series of 10 repetitive pinprick stimuli of the same physical intensity (1/s applied within an area of 1cm2).
Timepoint [3] 294686 0
Patient group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements, and 1 assessment post-treatment (week 5).
Healthy group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements.
Secondary outcome [1] 313863 0
Shoulder pain and disability index (SPADI)
Timepoint [1] 313863 0
Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.
Secondary outcome [2] 313961 0
Depression, anxiety and stress scale (DASS)
Timepoint [2] 313961 0
Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.
Secondary outcome [3] 313962 0
Quality of life (EuroQol questionnaire)
Timepoint [3] 313962 0
Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.

Eligibility
Key inclusion criteria
Shoulder pain in the anterosuperior aspect of the shoulder for longer than 6 weeks, and classified with shoulder impingement with at least 3 of the following findings: positive Neer impingement test, positive Hawkins-Kennedy test, positive Jobe test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation, pain with palpation of rotator cuff tendons, and pain in the C5 or C6 dermatome region.
Healthy subjects: no history of shoulder or neck pain or injury; no history of any kind of chronic pain.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of cancer, previous fractures of the shoulder complex, recent shoulder surgery, corticosteroid injection into the glenohumeral joint within the previous 6 months, any neurological or auto-immune disorder, any recent shoulder dislocation, or if the shoulder pain was considered to be cervical in origin, history of fainting, dizziness, lightheadedness, chest pain or shortness of breath, or any history of cardiac disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is just one treatment for shoulder pain patients, therefore just one group of subjects treated which will be compared with healthy subjects. The purpose of the study are to characterise the sensory profile of subjects with shoulder impingment and to identify predictors for the success of the treatment based on the pain profile of the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
There is no comparable data from people with shoulder pain on which to base our sample size. Based on similar work in whiplash, 22 participants with shoulder pain and 22 age- and sex-matched healthy controls will be recruited. Sample size was calculated based on a power analysis (0.80), and the assumption of a 2.1 degrees Celsius (SD 2.4) difference in CPM functioning between groups.
Paired sample t-tests will be used to compare within-subject differences in CPM measured at 30- and 60-seconds after the cold pressor test. Reliability of measures for each group will be assessed using intraclass correlation coefficients (ICC 3,1). To compare differences between shoulder pain and control groups at baseline, Wilcoxon signed rank test will be used for measurements with skewed distributions or one-way ANOVA for equal distributions (HPT, CPT, PPT, cold pressor test and TS). Linear correlations will be performed to assess predictor factors for the successful treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2015
Actual
23/02/2015
Date of last participant enrolment
Anticipated
27/04/2015
Actual
6/04/2015
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
46
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291019 0
Charities/Societies/Foundations
Name [1] 291019 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 291019 0
Brazil
Primary sponsor type
University
Name
Griffith University
Address
GRIFFITH UNIVERSITY
Parklands Drive
Southport, QLD 4222
Country
Australia
Secondary sponsor category [1] 289696 0
Charities/Societies/Foundations
Name [1] 289696 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Address [1] 289696 0
R. Pio XI, 1500
Alto da Lapa
CEP 05468-901 Sao Paulo/SP
Country [1] 289696 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292602 0
Griffith University Human Research Ethics Commitee
Ethics committee address [1] 292602 0
Ethics committee country [1] 292602 0
Australia
Date submitted for ethics approval [1] 292602 0
26/11/2014
Approval date [1] 292602 0
14/01/2015
Ethics approval number [1] 292602 0
AHS/65/14/HREC

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

Contacts
Principal investigator
Name 56174 0
Mrs Melina Nevoeiro Haik
Address 56174 0
PhD student at Griffith University
8 Gurrah avenue
Southport, QLD 4215.
Country 56174 0
Australia
Phone 56174 0
+61 0402553515
Fax 56174 0
Email 56174 0
m.nevoeirohaik@griffith.edu.au
Contact person for public queries
Name 56175 0
Melina Nevoeiro Haik
Address 56175 0
PhD student at Griffith University
8 Gurrah avenue
Southport, QLD 4215.
Country 56175 0
Australia
Phone 56175 0
+61 0402553515
Fax 56175 0
Email 56175 0
melhaik@gmail.com
Contact person for scientific queries
Name 56176 0
Leanne Bisset
Address 56176 0
Leanne Bisset PhD
Musculoskeletal Physiotherapist
Senior Lecturer
Office: G01 room 1.08
Menzies Health Institute Qld
Centre for Musculoskeletal Research
School of Allied Health Science
Griffith University
Parklands Drive
4215
Southport, Qld
Country 56176 0
Australia
Phone 56176 0
+617-55527717
Fax 56176 0
Email 56176 0
l.bisset@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
measures of pain modulation.
When will data be available (start and end dates)?
Any time. There is no end date of the availability of the data when asking for that by emailing the corresponding author.
Available to whom?
To whom it may concern.
Available for what types of analyses?
Any kind of analysis.
How or where can data be obtained?
By e-mail (corresponding author): l.bisset@griffith.edu.au


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.