NCT05869695

Brief Summary

Clinical guidelines for managing musculoskeletal pain recommend first, assessing and identifying any signs of severe physical conditions (i.e."red flags") and then, asessing the psychosocial prognostic factors of poor outcomes (i.e."yellow flags"). The Optimal Sreening for Prediction of Referral and Outcome (OSPRO) cohort studies were designed to develop and validate standard assessment tools for Review Of Systems (OSPRO-ROS) and Yellow Flags (OSPRO-YF).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

May 5, 2023

Last Update Submit

May 16, 2023

Conditions

Keywords

OSPROReview of SystemsRed FlagsPsychosocial factorsYellow FlagsCross-culturalReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Outcome Measure (PROM) development: Translation and Cross Cultural Adaptation to the Spanish population of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires.

    Two native Spanish speakers, health experienced in musculoskeletal pain and knowledge of English, translated into Spanish the Optimal Screening for Prediction of Referral and Outcome-Review of Systems (OSPRO-ROS) questionnaire original (English) and the Optimal Screening for Prediction of Referral and Outcome Yellow-Flags (OSPRO-YF) original questionnaire (English). Two native English speakers, knowledge of Spanish, reverse-translate the text to Spanish. 25 participants with musculoskeletal pain completed the Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaires. This outcome will be evaluated according the Consensus-based Standards for the selections of health Measurement Instruments (COSMIN) Risk of Bias checklist for PROMs, using their scoring manual: very good/adequate/doubtful/inadequate/NA for each standar.

    from September 2018 to July 2021

Secondary Outcomes (1)

  • OSPRO questionnaires Psychometric property Validation

    from January to June 2024

Study Arms (2)

OSPRO-ROS: 100 patients presenting musculoskeletal pain

Patients between 18 and 75 years of age with primary complaints involving the cervical spine, lumbar spine, shoulder or knee. Were able to read and comprehend Spanish.

Other: OSPRO-ROS Questionnaire

OSPRO-YF: 100 patients presenting musculoskeletal pain

Patients between 18 and 75 years of age with primary complaints involving the cervical spine, lumbar spine, shoulder or knee. Were able to read and comprehend Spanish.

Other: OSPRO-YF Questionnaire

Interventions

Completion of questionnaires

Also known as: Result of complementary tests, OSPRO-ROS retest
OSPRO-ROS: 100 patients presenting musculoskeletal pain

Completion of questionnaires

Also known as: Chronic Pain Acceptance Questionnaire (CPAQ), Fear-Avoidance Beliefs Questionnaire (FABQ), Pain Catastrophizing Scale (PCS), Patient Health Questionnaire-9 (PHQ-9), State Trait Anxiety Inventory (STAI), Tampa Scale for Kinesiophobia-11 (TSK-11), OSPRO-YF retest
OSPRO-YF: 100 patients presenting musculoskeletal pain

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

OSPRO-ROS: Person between 18 and 75 years of age who goes to the emergency department, presenting acute musculoskeletal pain with primary complaints involving the cervical spine, lumbar spine, shoulder or knee. OSPRO-YF: Person between 18 and 75 years of age who goes to the rehabilitation department, presenting chronic musculoskeletal pain with primary complaints involving the cervical spine, lumbar spine, shoulder or knee.

You may qualify if:

  • OSPRO-ROS:
  • Were coming to the emergency department on their first visit.
  • With acute musculoskeletal pain.
  • Were able to read and comprehed Spanish language.
  • OSPRO-YF:
  • Were seeking outpatient physical therapy treatment.
  • With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.
  • Were able to read and comprehend Spanish language.

You may not qualify if:

  • Widespread chronic pain syndrome (e.g. fibromyalgia or irritable bowel syndrome).
  • Neuropathic pain syndrome (e.g. complex regional pain syndrome or diabetic neuropathy).
  • Psychiatric history (currently in care of mental health care provider or taking \> 2 precription psychiatric medications)
  • Cancer (currently receiving treatment for active cancer)
  • Neurological disorder (e.g. stroke, spinal cord injury, or traumatic brain injury).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Asepeyo Sant Cugat

Sant Cugat del Vallès, Barcelona, 08174, Spain

RECRUITING

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • ENRIQUE LLUCH GIRBÉS

    UNIVERSITAT DE VALÈNCIA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MELÀNIA MASÓ NÚÑEZ

CONTACT

MARTA TELLO FONTANET

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 22, 2023

Study Start

November 30, 2020

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations