Musculoskeletal DiseasesNCT03785561
Effect of Research Participation Versus Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders
An observational study of Musculoskeletal Diseases and Osteoarthritis, Knee, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases, Osteoarthritis, Knee, Illness Perceptions
- What is being tested?
- participation in a health research study
- How many people
- 1,850 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- We have no formal exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Research Participation vs. Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders: Protocol for a Prospective Cohort Study
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.
Read the 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.
- Being tested
- participation in a health research study
- Keywords
- Musculoskeletal Diseases, Osteoarthritis, Knee, cohort study, illness perceptions
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participation in a health research studyOther
Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and end of study (<=1 year)
Secondary outcomes (5)
PainDETECT questionnaire
PainDETECT questionnaire was developed to detect neuropathic pain components in adult patients. The questionnaire consists of seven questions addressing the quality of neuropathic pain symptoms; it is completed entirely by the patient. It contains seven questions that address the quality of neuropathic pain symptoms scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5), four questions addressing the pain course pattern (scored from -1 to +1) and one question concerning radiation of pain into other parts of the body (yes (+2)/no (0)). The final score between -1 and 38 indicates the likelihood of a neuropathic pain component. A score of ≤ 12 indicates that pain is unlikely to have a neuropathic component, while a score of ≥ 19 suggests that pain is likely to have a neuropathic component
Measured: At baseline and end of study (<=1 year)
The Brief Illness Perception Questionnaire
The Brief illness perception questionnaire BIPQ is a generic questionnaire developed to measure illness perception in a variety of illnesses. The questionnaire is patient-reported and assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. It contains eight numerical rating scales questions (0-10) and a memo field based on the patients' own beliefs about their condition. In some circumstances it may be possible to compute an overall score which represents the degree to which the illness is perceived as threatening or benign. To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8. A higher score reflects a more threatening view of the illness.
Measured: At baseline and end of study (<=1 year)
Widespread Pain Index
Guided by a drawing the participants indicate each area that they have felt pain in over the last week. Pain due to other known illnesses should be excluded from the assessment. There are 19 areas and the index ranges from 0 - 19, with 19 being worst. The WPI is used as part of the ACR fibromyalgia classification criteria but can be used for other pain related disorders
Measured: At baseline and end of study (<=1 year)
EQ-5D-3L
EQ-5D is a standardised measure of health status that provides a simple, generic measure of health. It is applicable to a wide range of health conditions. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews and takes only a few minutes to complete. The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents
Measured: At baseline and end of study (<=1 year)
Health Assessment Questionnaire (Disability)
HAQ-DI (HAQ-disability) contains 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. If one section is not completed by a subject, then the summed score would be divided by 7. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability
Measured: At baseline and end of study (<=1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, DMSc, Principal investigator, The Parker institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785561
- Sponsor's protocol ID
- Study participation MSK
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2018
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Capital region of Denmark will normally only accept sharing of anonymous data
Publications
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.
PubMed 37797965
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Research Participation vs. Usual Clinical Treatment on Pain in Patients With Musculoskeletal Disorders: Protocol for a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03785561
- Acronym / sponsor ID
- Study participation MSK
- Keywords
- Musculoskeletal Diseases, Osteoarthritis, Knee, cohort study, illness perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed (intervention) group | – | Other: participation in a health research studyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- We have no formal exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| participation in a health research studyPatients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital | Other | Exposed (intervention) group |
Primary outcome
The Brief Pain Inventory short form
Time frame: At baseline and end of study (<=1 year)
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
5 secondary outcomes
PainDETECT questionnaire
Time frame: At baseline and end of study (<=1 year)
The Brief Illness Perception Questionnaire
Time frame: At baseline and end of study (<=1 year)
Widespread Pain Index
Time frame: At baseline and end of study (<=1 year)
EQ-5D-3L
Time frame: At baseline and end of study (<=1 year)
Health Assessment Questionnaire (Disability)
Time frame: At baseline and end of study (<=1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 37797965Ginnerup-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.
- Individual participant dataSharing planned: Undecided. The Capital region of Denmark will normally only accept sharing of anonymous data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bliddal, DMSc principal investigator
The Parker institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases and Osteoarthritis, Knee, run by Frederiksberg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Brief Pain Inventory short form (time frame: At baseline and end of study (<=1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.