Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires

Recruiting

• Conditions: Musculoskeletal Pain
• Interventions: Other: OSPRO-YF Questionnaire; Other: OSPRO-ROS Questionnaire

• Registration Number: NCT05869695
• Lead Sponsor: University of Valencia

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.

Study Timeline

• Study Start: 2020-11-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSPRO-YF: 100 patients presenting musculoskeletal pain	OSPRO-YF Questionnaire	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.
OSPRO-ROS: 100 patients presenting musculoskeletal pain	OSPRO-ROS Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
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.	from September 2018 to July 2021	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.

Secondary Outcome Measures

Name	Time	Method
OSPRO questionnaires Psychometric property Validation	from January to June 2024	The validity and reliability of the Spanish version translated from the questionnaires Optimal Screening for Prediction of Referral and Outcome (OSPRO) will be assessed.; 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.

Trial Locations

Locations (2)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Asepeyo Sant Cugat; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain