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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
Sponsor:
Collaborator:
Research Unit of General Practice, Aalborg
Information provided by (Responsible Party):
Sinead Holden, Aalborg University

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.


Condition or disease
Musculoskeletal Pain Insomnia Anxiety Depressive Symptoms

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.


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Study Type : Observational
Estimated Enrollment : 299 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

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


Locations
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Denmark
Research Unit for General Practice in Aalborg
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University
Research Unit of General Practice, Aalborg
Investigators
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Principal Investigator: Sinead Holden, PhD Research Unit of General Practice, Aalborg

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Responsible Party: Sinead Holden, Post- Doctoral Research Fellow, Aalborg University
ClinicalTrials.gov Identifier: NCT03726138     History of Changes
Other Study ID Numbers: LS MSK FU
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Depression
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms