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Completed

NCT Number: NCT03726138

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

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.

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Key information

Conditions

Musculoskeletal Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Dyssomnias Insomnia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Unit for General Practice in Aalborg

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. New onset musculoskeletal pain

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Research Unit for General Practice in Aalborg

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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