Clinical trial NCT05869695: Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires
Official title: Transcultural Adaptation and Validation to Spanish of the Optimal Screening for Prediction of Referral and Outcome (OSPRO) Questionnaires for Review-Of-Systems (OSPRO-ROS) and Yellow-Flags (OSPRO-YF) in Subjects With Musculoskeletal Pain.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Pain
Keywords: OSPRO
Review of Systems
Red Flags
Psychosocial factors
Yellow Flags
Cross-cultural
Reliability
Validity
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: University of Alcala
name: Escoles Universitaries Gimbernat
name: Hospital ASEPEYO Sant Cugat
name: Consorci Sanitari de Terrassa
First posted: 2023-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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).

Detailed description: The objectives of this study were to translate and cross-cultural adapt OSPRO-ROS and OSPRO-YF questionnaires to Spanish and to investigate their psychometric properties for their use in subjects with musculoskeletal pain.To accomplish the objectives proposed, this study was developed in two phases:Phase I: Cross-cultural adaptation process.Phase II: Psychometric properties evaluation.

Eligibility criteria: Inclusion Criteria:

OSPRO-ROS:

1. Were coming to the emergency department on their first visit.
2. With acute musculoskeletal pain.
3. Were able to read and comprehed Spanish language.

OSPRO-YF:

1. Were seeking outpatient physical therapy treatment.
2. With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.
3. Were able to read and comprehend Spanish language.

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: from September 2018 to July 2021
Secondary outcomes:
measure: OSPRO questionnaires Psychometric property Validation
timeFrame: from January to June 2024
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Asepeyo Sant Cugat
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: UNIVERSITAT DE VALÈNCIA
name: ENRIQUE LLUCH GIRBÉS
role: PRINCIPAL_INVESTIGATOR
References: