The Association of Sleep and Psychological Symptoms With Prognosis of MSK Pain in Danish General Practice
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|ClinicalTrials.gov Identifier: NCT03726138|
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2018
Last Update Posted : January 15, 2019
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.
|Condition or disease|
|Musculoskeletal Pain Insomnia Anxiety Depressive Symptoms|
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.
|Study Type :||Observational|
|Estimated Enrollment :||299 participants|
|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|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||February 1, 2019|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726138
|Research Unit for General Practice in Aalborg|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Sinead Holden, PhD||Research Unit of General Practice, Aalborg|