SpanishOSPRO: Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires

Sponsor

University of Valencia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05869695

Collaborator

University of Alcala (Other), Escoles Universitaries Gimbernat (Other), Hospital ASEPEYO Sant Cugat (Other), Consorci Sanitari de Terrassa (Other)

200

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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).