NCT05366946

Brief Summary

This study explores the prevalence of chronic pain in individuals with COPD compared to healthy controls and examines the clinical implications of pain on symptoms associated with COPD, psychological effect and physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
6.5 years until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

July 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

October 20, 2015

Last Update Submit

July 11, 2022

Conditions

Keywords

Pain

Outcome Measures

Primary Outcomes (4)

  • Brief Pain Inventory

    Collates information on pain intensity using numerical rating scales, with a higher score denoting greater intensity.

    Day 1

  • Extended Aberdeen Back Pain Scale (EABPS)

    Measure of neck, upper and lower back pain from 35 questions with an overall total score

    Day 1

  • Self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)

    Consists of 9 items identifying the presence or absence of clinical signs and symptoms with a score of ≥ 12 indicative of neuropathic pain.

    Day 1

  • Pain Catastrophizing Scale (PCS)

    Assesses the presence and extent of catastrophic thoughts or feelings accompanying pain experiences from 13 questions.

    Day 1

Study Arms (2)

COPD - prevalence

Diagnosed with COPD (based on GOLD criteria and history of \> 10 pack years of smoking) and no history of recent musculoskeletal injuries (within last 4 weeks) - prevalence study

Other: Prevalence study

Healthy controls - prevalence

Not diagnosed with COPD or other respiratory conditions or recent musculoskeletal injuries (within last 4 weeks) - prevalence study

Other: Prevalence study

Interventions

Prevalence study of chronic pain in COPD vs healthy controls

COPD - prevalenceHealthy controls - prevalence

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosed with COPD according to GOLD criteria and history of smoking \> 10 pack years

You may qualify if:

  • No diagnosis of COPD or other respiratory conditions
  • No recent history (within last 4 weeks) of musculoskeletal injury

You may not qualify if:

  • Diagnosis of other respiratory disease, including COPD
  • Recent musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePain

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Roger Goldstein, MD

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Physician

Study Record Dates

First Submitted

October 20, 2015

First Posted

May 10, 2022

Study Start

July 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

July 14, 2022

Record last verified: 2022-04

Locations