OsteoarthitisNCT06785883
Screening Anxiety and Depression Among Patients with Chronic Musculoskeletal Pain Within Physiotherapy Practices
An observational study of Osteoarthitis and Fibromyalgia, run by KU Leuven at 1 site in Belgium.
Trial summary
This study will investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain (primary aim). The prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthitis, Fibromyalgia, Rheumatoid Arthritis (RA
- How many people
- 750 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2023to 2 Jan 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain
Who may be able to join
- Physiotherapists:
- Physiotherapists of AXXON, the Belgian Professional Physiotherapy Organization.
- Patients
- Self-reported chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia.
Who cannot join
- Not meeting inclusion criteria.
- No additional exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain (primary aim). The prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices will be established (secondary aim).
Read the detailed description
The International Classification of Diseases describes chronic musculoskeletal pain as pain that arises as part of a disease process directly affecting bones, joints, muscle or related soft tissue lasting longer than 3 months. The global burden of chronic musculoskeletal pain is substantial, with a recent systematic review indicating a 26% prevalence in the general adult population and 39% in those older than 65 year. Chronic musculoskeletal pain also contributes to almost 20% of the global years-lived with disability, and it is one of the major causes of work loss and early retirement. Population-based research has shown that chronic pain conditions are risk factors for developing depression and anxiety. Co-morbid depression and anxiety are strongly associated with more severe pain, greater disability, and poorer health related quality of life. Both are also important reasons for poor treatment adherence within physiotherapy practices. When managing patients with chronic musculoskeletal pain, physiotherapists need to be able to identify patients who have an increased likelihood of depression and anxiety and to facilitate appropriate management by either facilitating patients in coping with anxiety and depression via for example physical activity or relaxation techniques and/or referring them to a medical practitioner for definitive diagnosis and intervention. Although there is some recognition of screening for depression in physiotherapy practices, the role physiotherapists can have in detecting anxiety and depression is largely ignored. The primary aim of this project will be to investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain. The focus will in particular be on patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia. The accuracy of screening via a numeric rating scale will be compared with the accuracy of screening via 2 brief items. A secondary aim is to describe the prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices.
- Conditions
- Osteoarthitis, Fibromyalgia, Rheumatoid Arthritis (RA, Low Back Pain, Neck Pain
- Medical subject headings
- Fibromyalgia, Arthritis, Rheumatoid, Low Back Pain, Neck Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder - 7
The Generalized Anxiety Disorder Assessment (GAD-7) (14) is a seven-item instrument that is used to measure or assess the severity of anxiety symptoms. Each item asks the individual to rate the severity of their symptoms over the past two weeks. Each item is scored on a Likert scale with symptoms rated as 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day). The total score ranges from 0 to 21. Higher scores implicate more severe symptoms. The optimal cut-off scores for the presence of mild, moderately severe and severe depressive symptoms is 5≤9, 10≤14 and 15≤ respectively (14).
Measured: 2 weeks
Patient Health Questionnaire -9
Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a nine-item depression scale (13). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Each item is scored on a Likert scale with symptoms rated as 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day). The total score ranges from 0 to 27. Higher scores implicate more severe symptoms. The optimal cut-off scores for the presence of mild, moderate and severe depressive symptoms is 5≤9, 10≤19, and 20≤ respectively (13).
Measured: 2 weeks
Numeric Rating Scale
Each physiotherapist will be requested to complete a patient evaluation form with a 0-to-10 numeric rating scale to rate whether the patient they just treated exhibited symptoms of anxiety and / or depression. Ratings will be allocated as 0 = "not at all depressed" and "not at all anxious"; 5 = "depressed" and "anxious" and 10 = "extremely depressed" and "extremely anxious".
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start2 Jan 2023
- Primary completion20 Dec 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthitisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davy Vancampfort, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785883
- Sponsor's protocol ID
- S67100
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Anxiety and Depression Among Patients with Chronic Musculoskeletal Pain Within Physiotherapy Practices
- ClinicalTrials.gov ID
- NCT06785883
- Acronym / sponsor ID
- S67100
- Conditions
- Osteoarthitis, Fibromyalgia, Rheumatoid Arthritis (RA, Low Back Pain, Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 21 Jan 2025 (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 will investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain (primary aim). The prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices will be established (secondary aim).
Detailed description
The International Classification of Diseases describes chronic musculoskeletal pain as pain that arises as part of a disease process directly affecting bones, joints, muscle or related soft tissue lasting longer than 3 months. The global burden of chronic musculoskeletal pain is substantial, with a recent systematic review indicating a 26% prevalence in the general adult population and 39% in those older than 65 year. Chronic musculoskeletal pain also contributes to almost 20% of the global years-lived with disability, and it is one of the major causes of work loss and early retirement. Population-based research has shown that chronic pain conditions are risk factors for developing depression and anxiety. Co-morbid depression and anxiety are strongly associated with more severe pain, greater disability, and poorer health related quality of life. Both are also important reasons for poor treatment adherence within physiotherapy practices. When managing patients with chronic musculoskeletal pain, physiotherapists need to be able to identify patients who have an increased likelihood of depression and anxiety and to facilitate appropriate management by either facilitating patients in coping with anxiety and depression via for example physical activity or relaxation techniques and/or referring them to a medical practitioner for definitive diagnosis and intervention. Although there is some recognition of screening for depression in physiotherapy practices, the role physiotherapists can have in detecting anxiety and depression is largely ignored. The primary aim of this project will be to investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain. The focus will in particular be on patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia. The accuracy of screening via a numeric rating scale will be compared with the accuracy of screening via 2 brief items. A secondary aim is to describe the prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain
Key inclusion criteria (4 listed)
- Physiotherapists of AXXON, the Belgian Professional Physiotherapy Organization.
- Patients
- Self-reported chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia.
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria.
- No additional 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.
Primary outcome
Generalized Anxiety Disorder - 7
Time frame: 2 weeks
The Generalized Anxiety Disorder Assessment (GAD-7) (14) is a seven-item instrument that is used to measure or assess the severity of anxiety symptoms. Each item asks the individual to rate the severity of their symptoms over the past two weeks. Each item is scored on a Likert scale with symptoms rated as 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day). The total score ranges from 0 to 21. Higher scores implicate more severe symptoms. The optimal cut-off scores for the presence of mild, moderately severe and severe depressive symptoms is 5≤9, 10≤14 and 15≤ respectively (14).
Patient Health Questionnaire -9
Time frame: 2 weeks
Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a nine-item depression scale (13). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Each item is scored on a Likert scale with symptoms rated as 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day). The total score ranges from 0 to 27. Higher scores implicate more severe symptoms. The optimal cut-off scores for the presence of mild, moderate and severe depressive symptoms is 5≤9, 10≤19, and 20≤ respectively (13).
Numeric Rating Scale
Time frame: 2 weeks
Each physiotherapist will be requested to complete a patient evaluation form with a 0-to-10 numeric rating scale to rate whether the patient they just treated exhibited symptoms of anxiety and / or depression. Ratings will be allocated as 0 = "not at all depressed" and "not at all anxious"; 5 = "depressed" and "anxious" and 10 = "extremely depressed" and "extremely anxious".
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 21 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthitis and Fibromyalgia, run by KU Leuven at 1 site in Belgium.
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 4 inclusion and 2 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 21 Jan 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 Belgium. 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?
Generalized Anxiety Disorder - 7 (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2025.