Psychometric properties of pain and physical functioning outcome measures in patients with diabetic neuropathic pain.

Investigating the psychometric properties of patient-reported outcome measures in individuals with chronic diabetic neuropathic pain: a prospective longitudinal cohort study protocol

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000748718

Acronym

None

Enrollment

Registered

2013-07-04

Start date

2013-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Participants who are unable to comprehend and record outcome measure data will be excluded.

Outcome results