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

NCT03726138 | Completed DMC

• 1 other identifier: LS MSK FU
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Insomnia; Anxiety; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• New onset musculoskeletal pain

  1 year

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Aalborg University: lead
• Research Unit for General Practice in Aalborg: collaborator

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sinead Holden, PhD

  Research Unit for General Practice in Aalborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post- Doctoral Research Fellow

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2019-01

Locations

DK (1)