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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Belgium
      • Leuven, Belgium
        • Private physiotherapy practices

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
2 weeks
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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