Musculoskeletal PainSpanishOSPRONCT05869695
Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires
An observational study of Musculoskeletal Pain, run by University of Valencia at 2 sites in Spain.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- OSPRO-ROS Questionnaire and OSPRO-YF Questionnaire
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Nov 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Asepeyo Sant Cugat
Sant Cugat del Vallès, Barcelona, 08174
MANUEL TORELLÓ VILAR, +34935653900, mtorellovilar@asepeyo.es
MELÀNIA MASÓ NÚÑEZ, +34935893727 ext. 218, melania.maso@eug.es
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
MARTA TELLO FONTANET, +34937003608 ext. 2025, MTello@CST.cat
MELÀNIA MASÓ NÚÑEZ, +34935893727 ext. 219, melania.maso@eug.es
About this study
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.
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).
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- OSPRO-ROS Questionnaire, OSPRO-YF Questionnaire
- Keywords
- OSPRO, Review of Systems, Red Flags, Psychosocial factors, Yellow Flags, Cross-cultural, Reliability, Validity
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSPRO-ROS QuestionnaireOther
Also called Result of complementary tests, OSPRO-ROS retest
Completion of questionnaires
OSPRO-YF QuestionnaireOther
Also called Chronic Pain Acceptance Questionnaire (CPAQ), Fear-Avoidance Beliefs Questionnaire (FABQ), Pain Catastrophizing Scale (PCS), Patient Health Questionnaire-9 (PHQ-9)
Completion of questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: OSPRO-YF Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from September 2018 to July 2021
Secondary outcomes (1)
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.
Measured: from January to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start30 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, Escoles Universitaries Gimbernat, Hospital ASEPEYO Sant Cugat, Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, Enrique Lluch Girbés, University of Valencia
- Investigators
- ENRIQUE LLUCH GIRBÉS, Principal investigator, UNIVERSITAT DE VALÈNCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869695
- Sponsor's protocol ID
- 102999
- Acronym
- SpanishOSPRO
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05869695
- Acronym / sponsor ID
- SpanishOSPRO / 102999
- Conditions
- Musculoskeletal Pain
- Keywords
- OSPRO, Review of Systems, Red Flags, Psychosocial factors, Yellow Flags, Cross-cultural, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- University of Alcala, Escoles Universitaries Gimbernat, Hospital ASEPEYO Sant Cugat, Consorci Sanitari de Terrassa
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSPRO-ROS: 100 patients presenting musculoskeletal pain | – | Other: OSPRO-ROS QuestionnairePatients 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-YF: 100 patients presenting musculoskeletal pain | – | Other: OSPRO-YF QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Were coming to the emergency department on their first visit.
- With acute musculoskeletal pain.
- Were able to read and comprehed Spanish language.
- Were seeking outpatient physical therapy treatment.
- With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSPRO-ROS QuestionnaireAlso: Result of complementary tests, OSPRO-ROS retestCompletion of questionnaires | Other | OSPRO-ROS: 100 patients presenting musculoskeletal pain |
| OSPRO-YF QuestionnaireAlso: Chronic Pain Acceptance Questionnaire (CPAQ), Fear-Avoidance Beliefs Questionnaire (FABQ), Pain Catastrophizing Scale (PCS), Patient Health Questionnaire-9 (PHQ-9)Completion of questionnaires | Other | OSPRO-YF: 100 patients presenting musculoskeletal pain |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
OSPRO questionnaires Psychometric property Validation
Time frame: from January to June 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ENRIQUE LLUCH GIRBÉS principal investigator
UNIVERSITAT DE VALÈNCIA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MELÀNIA MASÓ NÚÑEZ (+34935893727 ext. 219, melania.maso@eug.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: from September 2018 to July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.