Are Multimorbidity and Related Factors Associated With Non-response Bias in Patients With Spinal Pain?

NCT06333847 | Active Not Recruiting DMC

• 1 other identifier: K2023-059
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore if non-response bias exists among individuals with chronic back pain, focusing on the impact of chronic disease count, treatment burden from multimorbidity, and health-related quality of life. Data is gathered from patients at Aalborg University Hospital's Rheumatology Department via electronic means and medical records. The analysis comprises two-wave assessments, investigating disparities among patients responding to study invitations based on response patterns: first, second, or third invitation responses. Utilizing baseline data, a one-way ANOVA is employed to detect potential between-group variations in the mentioned factors. Subsequently, a repeated measures ANOVA is conducted to evaluate differences among groups over time. Additionally, statistical analyses are conducted to scrutinize variances in age and gender distribution between respondents and non-respondents to the questionnaire invitations at baseline.

Conditions

Back Pain; Low Back Pain; Neck Pain; Comorbidities and Coexisting Conditions

Keywords

back pain; low back pain; Neck pain; Comorbidities; coexisting conditions; Multimorbidity; Non-response bias; Successive wave-analysis

Outcome Measures

Primary Outcomes (1)

• Multimorbidity Treatment Burden Questionnaire (MTBQ).

  The MTBQ is a 10-item self-report measure designed to assess the burden experienced by individuals with multiple health conditions. The ten items cover various aspects of treatment burden, such as managing one's own health, including self-monitoring and lifestyle changes, dealing with medication-related challenges (e.g., adherence and obtaining prescriptions), coordinating healthcare appointments, and managing dependency on others. Each item was scored on a scale ranging from 0 to 100. A higher total score on the questionnaire indicates a higher burden. The MTBQ has been shown to possess good content validity, construct validity, reliability, and responsiveness and has a valid version in Danish.

  This PROM is collected at baseline, 3- and 6 month follow up

Secondary Outcomes (1)

• Health-related quality of life (EQ-5D-5L)

  This PROM is collected at baseline, 3- and 6 months follow up

Other Outcomes (5)

• Brief Pain Inventory - Short form

  This PROM is collected at baseline, 3- and 6 months follow up

• Insomnia Severity Index

  This PROM is collected at baseline, 3- and 6 months follow up

• Patient Health Questionnaire

  This PROM is collected at baseline, 3- and 6 months follow up

Study Arms (5)

Group 1

Patients who responded to the first invitation to participate

Group 2

Patients who responded to the second invitation to participate

Group 3

Patients who responded to the third invitation to participate

Group 4

Patients who did not respond to inviations to participate

Group 5

Patients who responded to invitations to participate and thus an amalgamation of the people from groups 1, 2 and 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals referred for spinal pain to Aalborg University Hospital\'s Department of Rheumatology between 1st of June 2023 to 1st of March 2024, were invited to participate.

You may qualify if:

• years old or above
• Diagnosed with neck or back pain and the diagnosis was established by or confirmed by a rheumatologist (clinical expert opinion)
• Speak, read and understand Danish

You may not qualify if:

• Withdraw consent

Sponsors & Collaborators

• Jacob Christiansen Gandløse: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: June 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

DK (1)