Trial Review

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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of pain modulation on shoulder pain management.
Scientific title
Does pain modulation influence clinical outcomes in patients with musculoskeletal shoulder pain: A prospective cohort study identifying responders and non-responders
Secondary ID [1] 297116 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 311134 0
Condition category
Condition code
Musculoskeletal 309761 309761 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313379 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318719 0
Global rating of change
Timepoint [1] 318719 0
6, 12, and 24 months post commencement of treatment in the tertiary care hospital
Primary outcome [2] 318720 0
Shoulder Pain & Disability Index
Timepoint [2] 318720 0
Baseline and at 6, 12, and 24 months post commencement of treatment in the tertiary care hospital
Secondary outcome [1] 365817 0
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.
Timepoint [1] 365817 0
baseline
Secondary outcome [2] 365818 0
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.
Timepoint [2] 365818 0
baseline
Secondary outcome [3] 365819 0
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.
Timepoint [3] 365819 0
baseline

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
9/08/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
23/12/2022
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
228
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12969 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 25447 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301678 0
Government body
Name [1] 301678 0
Queensland Health Office for Health Innovation Investment and Research Grant scheme
Country [1] 301678 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 301438 0
University
Name [1] 301438 0
Griffith University
Address [1] 301438 0
Parklands Drive
Gold Coast Campus
Qld 4222
Country [1] 301438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302397 0
Gold Coast Hospital and Health District Human Research Ethics Committee
Ethics committee address [1] 302397 0
Clinical Governance, Education and Research
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 302397 0
Australia
Date submitted for ethics approval [1] 302397 0
16/01/2018
Approval date [1] 302397 0
29/04/2019
Ethics approval number [1] 302397 0
HREC/2019/QGC/52528

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.
Trial website
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 90098 0
A/Prof Leanne Bisset
Address 90098 0
School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
Country 90098 0
Australia
Phone 90098 0
+61 755527717
Fax 90098 0
Email 90098 0
[email protected]
Contact person for public queries
Name 90099 0
Leanne Bisset
Address 90099 0
School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
Country 90099 0
Australia
Phone 90099 0
+61 755527717
Fax 90099 0
Email 90099 0
[email protected]
Contact person for scientific queries
Name 90100 0
Leanne Bisset
Address 90100 0
School of Health Science & Social Work, Griffith University Gold Coast Campus Qld 4222
Country 90100 0
Australia
Phone 90100 0
+61 755527717
Fax 90100 0
Email 90100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not currently approved by GCHEthics.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23719Study 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.