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

NCT ID: NCT03785561

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Diseases Osteoarthritis, Knee Illness Perceptions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

participation in a health research study

Intervention Type OTHER

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

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

No interventions assigned to this group

Interventions

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participation in a health research study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marius Henriksen

PT, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henning Bliddal, DMSc

Role: PRINCIPAL_INVESTIGATOR

The Parker institute

Locations

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The Parker Institute, Frederiksberg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 37797965 (View on PubMed)

Other Identifiers

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Study participation MSK

Identifier Type: -

Identifier Source: org_study_id

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