Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires (SpanishOSPRO)

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Other: OSPRO-ROS Questionnaire; Other: OSPRO-YF Questionnaire

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: MELÀNIA MASÓ NÚÑEZ; Phone Number: 219 +34935893727; Email: melania.maso@eug.es
• Study Contact Backup: Name: MARTA TELLO FONTANET; Phone Number: 2025 +34937003608; Email: MTello@CST.cat

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08174
      • Recruiting
      • Hospital Asepeyo Sant Cugat
      • Contact: MANUEL TORELLÓ VILAR; Phone Number: +34935653900; Email: mtorellovilar@asepeyo.es
      • Contact: MELÀNIA MASÓ NÚÑEZ; Phone Number: 218 +34935893727; Email: melania.maso@eug.es
    • Terrassa, Barcelona, Spain, 08227
      • Recruiting
      • Consorci Sanitari de Terrassa
      • Contact: MELÀNIA MASÓ NÚÑEZ; Phone Number: 219 +34935893727; Email: melania.maso@eug.es
      • Contact: MARTA TELLO FONTANET; Phone Number: 2025 +34937003608; Email: MTello@CST.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Completion of questionnaires; Other Names: Result of complementary tests; OSPRO-ROS retest
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; Completion of questionnaires; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSPRO questionnaires Psychometric property Validation	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.	from January to June 2024

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: University of Alcala; Consorci Sanitari de Terrassa; Escoles Universitaries Gimbernat; Hospital ASEPEYO Sant Cugat
• Investigators: Principal Investigator: ENRIQUE LLUCH GIRBÉS, Universitat de Valencia

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Validity; Reliability; Psychosocial factors; OSPRO; Review of Systems; Red Flags; Yellow Flags; Cross-cultural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 102999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No