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

Frederiksberg University Hospital

Status: Completed

Conditions: Illness Perceptions; Musculoskeletal Diseases; Osteoarthritis, Knee

Treatments: Other: participation in a health research study

Study type: Observational

Funder types: Other

Identifiers

NCT03785561

Study participation MSK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,850 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,850 participants in 2 patient groups

Exposed (intervention) group

Description:

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

Treatment:

Other: participation in a health research study

Unexposed (comparator) group

Description:

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