Clinical trial NCT03726138: The Association of Sleep and Psychological Symptoms With Prognosis of MSK Pain in Danish General Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Insomnia
Anxiety
Depressive Symptoms
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice in Aalborg
First posted: 2018-10-31
Enrollment: 299
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 12 years and over visiting the GP during the study period in November 2017. The patients who consented to participate in the follow-up (299 patients) are eligible for one-year follow-up.

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.

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.

Primary outcomes:
measure: Musculoskeletal pain (persistence)
timeFrame: 1 year
Secondary outcomes:
measure: New onset musculoskeletal pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Unit for General Practice in Aalborg
Study officials:
affiliation: Research Unit for General Practice in Aalborg
name: Sinead Holden, PhD
role: PRINCIPAL_INVESTIGATOR
References: