Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000748718
Ethics application status
Not yet submitted
Date submitted
20/06/2013
Date registered
4/07/2013
Date last updated
4/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychometric properties of pain and physical functioning outcome measures in patients with diabetic neuropathic pain.
Scientific title
Investigating the psychometric properties of patient-reported outcome measures in individuals with chronic diabetic neuropathic pain: a prospective longitudinal cohort study protocol
Secondary ID [1] 282708 0
Nil
Universal Trial Number (UTN)
U1111-1145-2867
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic peripheral neuropathic pain 289422 0
Condition category
Condition code
Neurological 289752 289752 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 289753 289753 0 0
Physiotherapy
Metabolic and Endocrine 289754 289754 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
The status of pain intensity and physical functioning will be observed in participants with diabetic peripheral neuropathic pain via two questionnaires (Pain outcome measure: modified Brief Pain Inventory for Diabetic Neuropathic Pain (BPI-DPN) item and scale & Physical functional outcome measure: Screening of Activity Limitation & Safety Awareness scale (SALSA)). The total duration of observation will be three months.
Intervention code [1] 287369 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289836 0
Primary outcome measure-1: Modified Brief Pain Inventory- Diabetic Peripheral Neuropathy Item scale
Timepoint [1] 289836 0
Time points: at baseline and at the end of 1st and 3rd month following baseline assessment
Primary outcome [2] 289837 0
Primary outcome measure- 2: Screening of Activity Limitation and Safety Awareness scale
Timepoint [2] 289837 0
At baseline and at 1 and 3 months after baseline assessment
Secondary outcome [1] 303352 0
Secondary Outcome measure: The Patient Global Impression of Change scale
Timepoint [1] 303352 0
At 1 and 3 months after baseline (Primary) assessment

Eligibility
Key inclusion criteria
1. Adults with a history of Diabetes; and having symptoms of neuropathic pain for > 3 months and scored 12 or more on Self-complete Leeds Assessment of Neuropathic Symptoms and Signs: (S-LANSS) will be eligible to participate in the study.

2. Participants should be able to understand English and provide informed consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are unable to comprehend and record outcome measure data will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Number of participants: 80

Test-retest reliability: Intraclass correlation coefficient

Validity testing: Pearson’s correlation coefficient

Responsiveness and for calculating minimal clinical important differences: Anchor based approach will be used (sensitivity and specificity approach, “within patients” score change, and “between patients” score change)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5155 0
New Zealand
State/province [1] 5155 0
Otago

Funding & Sponsors
Funding source category [1] 287479 0
University
Name [1] 287479 0
Centre for Health Activity and Rehabilitation Research (CHARR), University of Otago, Dunedin
Country [1] 287479 0
New Zealand
Primary sponsor type
Individual
Name
Professor David G Baxter
Address
School of Physiotherapy,
Centre for Health Activity and Rehabilitation Research, University of Otago
325 Great King Street, PO Box 56
Dunedin- 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286221 0
Individual
Name [1] 286221 0
Ms Poonam Mehta
Address [1] 286221 0
Doctoral student,
School of Physiotherapy,
Centre for Health Activity and Rehabilitation Research, University of Otago
325 Great King Street, PO Box 56
Dunedin- 9054
New Zealand
Country [1] 286221 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289454 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 289454 0
University of Otago,
Clock Tower Building
364 Leith Walk
9016
PO Box 56
Dunedin 9054
Otago State
Ethics committee country [1] 289454 0
New Zealand
Date submitted for ethics approval [1] 289454 0
02/07/2013
Approval date [1] 289454 0
Ethics approval number [1] 289454 0

Summary
Brief summary
This study will investigate the psychometric properties in specific pain intensity and physical functional outcome measures in adults with chronic diabetic Neuropathic pain (NeP). Specifically this study aims to:
1. Investigate the test-retest reliability of modified Brief Pain Inventory Diabetic Neuropathic Pain (BPI-DPN) scale and Screening of Activity Limitation and Safety Awareness (SALSA) scale in adults with chronic diabetic neuropathic pain (NeP).
2. Longitudinally investigate the responsiveness: Minimal Clinically important change (MCIC) of BPI-DPN and SALSA in adults with chronic diabetic NeP.
3. Observe the nature of relationship between pain intensity (BPI-DPN) and physical functioning (SALSA) outcome measures in adults with chronic diabetic NeP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40926 0
Ms Poonam Mehta
Address 40926 0
Poonam Mehta (Doctoral Candidate)
Centre for Health Activity and Rehabilitation Research, University of Otago
325 Great King Street, PO Box 56
Dunedin, 9054
New Zealand
Country 40926 0
New Zealand
Phone 40926 0
+64 (03) 479 5422
Fax 40926 0
+64 (03) 479 7411
Email 40926 0
[email protected]
Contact person for public queries
Name 40927 0
Ms Poonam Mehta
Address 40927 0
Poonam Mehta (Doctoral Candidate)
Centre for Health Activity and Rehabilitation Research, University of Otago
325 Great King Street, PO Box 56
Dunedin, 9054
New Zealand
Country 40927 0
New Zealand
Phone 40927 0
+64 (03) 479 5422
Fax 40927 0
+64 (03) 479 7411
Email 40927 0
[email protected]
Contact person for scientific queries
Name 40928 0
Ms Poonam Mehta
Address 40928 0
Poonam Mehta (Doctoral Candidate)
Centre for Health Activity and Rehabilitation Research, University of Otago
325 Great King Street, PO Box 56
Dunedin, 9054
New Zealand
Country 40928 0
New Zealand
Phone 40928 0
+64 (03) 479 5422
Fax 40928 0
+64 (03) 479 7411
Email 40928 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIInvestigating the psychometric properties of patient reported outcome measures in individuals with chronic diabetic neuropathic pain: prospective longitudinal cohort study protocol2014https://doi.org/10.1179/1743288x14y.0000000157
N.B. These documents automatically identified may not have been verified by the study sponsor.