The Association of Sleep and Psychological Symptoms With Prognosis of MSK Pain in Danish General Practice

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726138
• Other study ID #: LS MSK FU
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: January 2019
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Insomnia
• Musculoskeletal Pain

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice in Aalborg	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Research Unit of General Practice, Aalborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Musculoskeletal pain (persistence)	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	1 year
Secondary	New onset musculoskeletal pain	This outcome will be new onset MSK pain assessed by a self-report pain questionnaire. The incidence of MSK pain at one-year follow-up will be assessed among patients from general practice who reported no MSK pain at baseline.; To be classified as having MSK pain, the pain must occur at least weekly and negatively interfere with the patient's usual activities.	1 year