Clinical trial NCT03785561: Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders
Official title: Effect of Research Participation vs. Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders: Protocol for a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Osteoarthritis, Knee
Illness Perceptions
Keywords: Musculoskeletal Diseases
Osteoarthritis, Knee
cohort study
illness perceptions
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 1850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social care systems. Increases in life expectancy and ageing populations are expected to make MSK disorders one of the leading causes of disability by the year 2020.

When faced with a potentially life changing diagnosis of a chronic disease, people (in general) develop an organized pattern of perceptions about their condition, and how it impacts their lives and often, the essentially same stressful event may cause significant variations in perceptions. These different perceptions and coping strategies might affect the way the individual chooses to handle the disease and seek health care assistance, which altogether eventually may affect the course of the illness.

Study participation besides reassurance, could be hypothesized to induce beneficial outcomes for the patients, but is it reasonable to expect an effect of study participation regardless of study intervention, design and group allocation? And is an eventual effect mainly derived from the intervention or from the participants being a selected group?

It remains to be clarified, whether and how study participation affects the individual's treatment effect and perceptions of the illness.

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

• We have no formal exclusion criteria

Primary outcomes:
measure: The Brief Pain Inventory short form
timeFrame: At baseline and end of study (<=1 year)
Secondary outcomes:
measure: PainDETECT questionnaire
timeFrame: At baseline and end of study (<=1 year)
measure: The Brief Illness Perception Questionnaire
timeFrame: At baseline and end of study (<=1 year)
measure: Widespread Pain Index
timeFrame: At baseline and end of study (<=1 year)
measure: EQ-5D-3L
timeFrame: At baseline and end of study (<=1 year)
measure: Health Assessment Questionnaire (Disability)
timeFrame: At baseline and end of study (<=1 year)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The Parker institute
name: Henning Bliddal, DMSc
role: PRINCIPAL_INVESTIGATOR
References: