- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785883
Screening Anxiety and Depression Among Patients with Chronic Musculoskeletal Pain Within Physiotherapy Practices
January 20, 2025 updated by: Davy Vancampfort, KU Leuven
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).
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium
- Private physiotherapy practices
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Chronic pain
Description
Inclusion criteria:
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.
Exclusion criteria:
- Not meeting inclusion criteria.
- No additional exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
2 weeks
|
|
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).
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2 weeks
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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".
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2023
Primary Completion (Actual)
December 20, 2024
Study Completion (Actual)
January 2, 2025
Study Registration Dates
First Submitted
January 3, 2025
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 20, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S67100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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