Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders

NCT03785561 | Completed

• 1 other identifier: Study participation MSK
• Study Type: observational
• Target: 1,850
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects on pain, function and illness perceptions, of participating in clinical research versus being treated with standard care in patients with musculoskeletal disorders.

Conditions

Musculoskeletal Diseases; Osteoarthritis, Knee; Illness Perceptions

Keywords

Musculoskeletal Diseases; Osteoarthritis, Knee; cohort study; illness perceptions

Outcome Measures

Primary Outcomes (1)

• The Brief Pain Inventory short form

  The BPI measures the intensity of pain experienced within the last 24 hours and how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. In this study we will use the short version (BPI-SF). The BPI-SF is based on numerical rating scales (0-10). The arithmetic mean of the four severity items can be used as measures of pain severity. A lower score indicates less pain interference

  At baseline and end of study (<=1 year)

Secondary Outcomes (5)

• PainDETECT questionnaire

  At baseline and end of study (<=1 year)

• The Brief Illness Perception Questionnaire

  At baseline and end of study (<=1 year)

• Widespread Pain Index

  At baseline and end of study (<=1 year)

• EQ-5D-3L

  At baseline and end of study (<=1 year)

• Health Assessment Questionnaire (Disability)

  At baseline and end of study (<=1 year)

Study Arms (2)

Exposed (intervention) group

Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital.

Other: participation in a health research study

Unexposed (comparator) group

The unexposed group is defined as patients, diagnosed with a musculoskeletal disorder receiving standard clinical care at the outpatient osteoarthritis clinic at Bispebjerg and Frederiksberg Hospital. They are not currently enrolled in a health research study concerning their musculoskeletal disorder at Bispebjerg and Frederiksberg Hospital

Interventions

participation in a health research study OTHER

Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital

Exposed (intervention) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be based on a prospectively sampled cohort of patients from the outpatient osteoarthritis clinic at Frederiksberg Hospital (approximately 1100 patients per year). The OA clinic receives patients with all different kinds of musculoskeletal disorders - not only OA (e.g. rheumatic -, degenerative- and inflammatory disorders in the musculoskeletal system). Patients are identified and will be recruited as they come to the outpatient clinic as part of any health research study or as patients not currently participating in a health research study.

You may qualify if:

• ≥ 18 years of age
• Diagnosed with a musculoskeletal disorder
• Currently enrolled in a health research study hosted by the outpatient osteoarthritis clinic at Frederiksberg Hospital OR Being treated in the outpatient osteoarthritis clinic at Frederiksberg Hospital and not participating in a health research study
• Reads and speaks Danish
• Consents to participation in this survey

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Related Publications (1)

• Ginnerup-Nielsen E, Christensen R, Bliddal H, Henriksen M. Effect of research participation versus usual clinical care in patients with rheumatic and musculoskeletal disorders: a prospective cohort study. RMD Open. 2023 Oct;9(4):e003414. doi: 10.1136/rmdopen-2023-003414.

  PMID: 37797965 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Henning Bliddal, DMSc

  The Parker institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Professor

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 27, 2025

Record last verified: 2022-08

Locations

DK (1)