NCT06785883

Brief 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 arthritis, osteoarthritis or fibromyalgia within physiotherapy practices will be established (secondary aim).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 3, 2025

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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".

    2 weeks

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private physiotherapy practices

Leuven, Belgium

Location

MeSH Terms

Conditions

FibromyalgiaArthritis, RheumatoidLow Back PainNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesArthritisJoint DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 21, 2025

Study Start

January 2, 2023

Primary Completion

December 20, 2024

Study Completion

January 2, 2025

Last Updated

January 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations