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Trial registered on ANZCTR
Registration number
ACTRN12619000114145
Ethics application status
Approved
Date submitted
21/01/2019
Date registered
24/01/2019
Date last updated
31/05/2024
Date data sharing statement initially provided
24/01/2019
Date results information initially provided
31/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Impact of pain modulation on shoulder pain management.
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Scientific title
Does pain modulation influence clinical outcomes in patients with musculoskeletal shoulder pain: A prospective cohort study identifying responders and non-responders
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Secondary ID [1]
297116
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
shoulder pain
311134
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Condition category
Condition code
Musculoskeletal
309761
309761
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Usual care for musculoskeletal shoulder pain within an orthopaedic department in a tertiary care hospital. For example, usual treatment may include conservative (physiotherapy), injection therapy, surgery.
Outcome assessment of predictor and confounding variables will occur at baseline, and clinical outcomes assessment will occur at 6, 12, and 24 months follow up.
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Intervention code [1]
313379
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Global rating of change
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Assessment method [1]
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0
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Timepoint [1]
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6, 12, and 24 months post commencement of treatment in the tertiary care hospital
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Primary outcome [2]
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Shoulder Pain & Disability Index
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Assessment method [2]
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0
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Timepoint [2]
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Baseline and at 6, 12, and 24 months post commencement of treatment in the tertiary care hospital
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Secondary outcome [1]
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Treatment effect modifier: Pressure Pain Threshold (PPT). PPT will be measured at baseline using a pressure algometer (Commander Echo Algometer, JTech Medical, USA). PPT is defined as the minimal amount of pressure (kg) applied to the skin at which a participant first perceives a change in sensation from one of pressure to one of pressure with discomfort/pain.
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Assessment method [1]
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0
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Timepoint [1]
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baseline
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Secondary outcome [2]
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Treatment effect modifier: Conditioned Pain Modulation (CPM). CPM will be measured using a cold water bath at 8 degrees Celsius as the conditioning stimulus, and PPT as the test stimulus. Following initial PPT measures, participants will be asked to immerse their hand up to the wrist on the unaffected side into the cold water bath for a maximum of 2 minutes. PPT (applied over the middle deltoid muscle on the affected side) will be measured at 30, 60, 90, and 120 seconds during cold water immersion, and then at 30 and 60 seconds following removal of the hand from the water. The difference in PPTs between baseline and during water immersion, and from baseline to post-water immersion, will be calculated and used in further analyses.
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Assessment method [2]
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0
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Timepoint [2]
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baseline
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Secondary outcome [3]
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Treatment effect modifier: Temporal Summation (TS). A 256mN weighted Pinprick Stimulator (MRC, Germany) will be used to measure mechanical TS. The weighted pinprick will be applied as a single stimulus to the middle deltoid muscle, upper trapezius muscle and between the 1st and 2nd metacarpals on the dorsum of the hand bilaterally, and an initial measure of pain severity will be recorded using a 0-10 numerical rating scale. Following this, 10 stimuli will be applied within 1cm2 of the same area with a 1-second interval between each stimulus. Participants will be asked to rate the level of pinprick pain intensity immediately following the last of the 10-stimuli train, and the difference between the last and first pain scores will be calculated as the TS score.
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Assessment method [3]
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Timepoint [3]
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baseline
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Eligibility
Key inclusion criteria
- Aged 18 - 75 years
- Have a referral to the hospital Orthopaedic Department for shoulder pain
- Have the ability to read trial literature (in English) and give consent
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- any inflammatory arthritis such as rheumatoid arthritis,
- neurological impairment (e.g., stroke, brain injury, nerve injury),
- known malignancy,
- currently taking neuropathic or opioid pain medication (e.g., gabapentin, pregabalin),
- uncontrolled high blood pressure,
- history of cardiac disease,
- haemophilia,
- current pregnancy or breast feeding,
- any open wounds or other contraindications (e.g., Raynaud's disease) that will prevent the person from immersing their hand in cold water
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Predictor (CPM, TS, PPT) and confounding variables (PCS, DASS-21, EQ-5D) and treatment (conservative, injections, surgery) will be assessed through their inclusion individually in the regression model, and will remain if they significantly influence the outcomes (p<0.1).
The association between the baseline predictor variables and the clinical outcomes will be evaluated using multivariable logistic regression analyses with Backward Wald selection.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
4/03/2019
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Actual
9/08/2019
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Date of last participant enrolment
Anticipated
31/12/2019
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Actual
23/12/2022
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
228
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Accrual to date
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Final
119
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
25447
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Queensland Health Office for Health Innovation Investment and Research Grant scheme
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Address [1]
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Level 13, 33 Charlotte Street, Brisbane, QLD 4000
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Country [1]
301678
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Australia
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Primary sponsor type
Hospital
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Name
Gold Coast University Hospital
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Address
1 Hospital Blvd
Southport
QLD 4215
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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Parklands Drive
Gold Coast Campus
Qld 4222
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Country [1]
301438
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Gold Coast Hospital and Health District Human Research Ethics Committee
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Ethics committee address [1]
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Clinical Governance, Education and Research
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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16/01/2018
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Approval date [1]
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29/04/2019
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Ethics approval number [1]
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HREC/2019/QGC/52528
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Summary
Brief summary
The primary aims of this study are to:
1) Evaluate pain modulation capacity in people with musculoskeletal shoulder pain; and
2) Investigate the effects of pain modulation on treatment outcomes in people with musculoskeletal shoulder pain.
Study design: Prospective longitudinal cohort study with 6-month, 12-month, and 24-month follow up
Outcome measures will be collected at baseline and at 6, 12, and 24 months follow up. These include:
1) Demographic, condition history information, physical screening (baseline)
2) Pain modulation tests (predictors, therefore only collected at baseline) and psychosocial questionnaires (baseline)
3) The outcomes to determine treatment effect are the Shoulder Pain & Disability Index and the Global Rating of Change (GROC) score, evaluated at baseline (Shoulder Pain & Disability Index only), and 6, 12, and 24 months follow up.
Individuals aged 18-75 years who have a referral for treatment of musculoskeletal shoulder pain will be included in this study.
Following baseline assessment, patients will undergo usual care for their shoulder pain, and clinical outcomes (global rating of change; pain and disability) will be collected at 6, 12, and 24 months follow up. The type of treatment received will be elicited from participants at follow up and extracted/confirmed from medical records.
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Trial website
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Trial related presentations / publications
Nil to date
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Leanne Bisset
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Address
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School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
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Country
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Australia
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Phone
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+61 755527717
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Fax
90098
0
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Email
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[email protected]
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Contact person for public queries
Name
90099
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A/Prof Leanne Bisset
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Address
90099
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School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
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Country
90099
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Australia
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Phone
90099
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+61 755527717
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Fax
90099
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Leanne Bisset
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Address
90100
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School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
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Country
90100
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Australia
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Phone
90100
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+61 755527717
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Fax
90100
0
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Email
90100
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Not currently approved by GCHEthics.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23719
Study protocol
376760-(Uploaded-08-05-2024-12-25-15)-Study-related document.pdf
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.
Download to PDF