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Clinical Trials/NCT03726138
NCT03726138
Completed
Not Applicable

The Association of Sleep and Psychological Symptoms With Prognosis and Onset of MSK Pain; a One-year Prospective Cohort Study in Danish General Practice

Aalborg University1 site in 1 country299 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Pain
Sponsor
Aalborg University
Enrollment
299
Locations
1
Primary Endpoint
Musculoskeletal pain (persistence)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Musculoskeletal (MSK) pain is a major public health concern. Approximately one in four consult their general practitioner (GP) with a musculoskeletal problem during the course of a year, making it the largest diagnostic group.

Modifiable factors including affective disorders (e.g. anxiety and depressive symptoms) and sleep problems may be important prognostic factors for MSK pain. However, there is a lack of prospective research examining the interaction between these conditions in patients with MSK pain in a GP-setting.

Detailed Description

This is a prospective cohort study of 299 participants from a GP-setting. Investigators will evaluate the occurrence of MSK pain at one-year follow-up and how the predictors (anxiety, depressive, and sleep problems and multi-site MSK pain) are associated with prognosis of MSK pain. A secondary aim will be to identify those factors associated with new onset MSK pain. Participants will complete a sleep questionnaire (the ATHENS insomnia questionnaire) containing 8 questions about sleep quality and quantity and a questionnaire (The Hospital Anxiety and Depression Score)) containing 14 questions focusing on anxiety and depression.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
February 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Sinead Holden

Post- Doctoral Research Fellow

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Patients aged 12 years visiting the GP who contributed baseline data and over who consented to be contacted as part of a prospective cohort study
  • Based on baseline assessment, patients were divided into two separate groups: The MSK pain group and the control group (representing the pain-free background population in general practice).
  • Inclusion Criteria for MSK pain group:
  • Musculoskeletal pain at any body site
  • Pain least once a week during the preceding month
  • Pain that negatively interfere with the participant's usual activities.
  • The same criteria for 'MSK pain' apply for the follow-up study.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Musculoskeletal pain (persistence)

Time Frame: 1 year

The primary outcome of this study will be MSK pain as evaluated by a self-report pain questionnaire. To be classified as having MSK pain, the pain must occur at least weekly and negatively interfere with the patient's usual activities. The prevalence of MSK pain at follow-up will be assessed to determine if patients from general practice who reported MSK pain at baseline still have MSK pain at one-year follow-up

Secondary Outcomes

  • New onset musculoskeletal pain(1 year)

Study Sites (1)

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