Musculoskeletal DiseasesNCT04011917
Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department
An observational study of Musculoskeletal Diseases, run by Slagelse Hospital at 1 site in Denmark.
Trial summary
This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital. Patients treated by the ESP during a 3 month period will be included in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Diseases
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 432 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2019to 15 Nov 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated by an ESP physiotherapist in the emergency room at Slagelse Hospital, Denmark, in a 3 month period +1 month follow-up will be invited to participate in this study.
Who may be able to join
- 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
- 2 Has an email address
- 3 Signed informed consent form
Who cannot join
- 1 A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., not having access to the internet, cognitive impairments etc.)
- 2 Under the influence of drugs or alcohol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Emergency Department, Slagelse Hospital
Slagelse, Region Sjælland, 4200
About this study
Official title: Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department: A Prospective Cohort Study
This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital.
Patients treated by the ESP during a 3 month period will be included in this study.
Furthermore we aim to assess if ESPs treating patients with minor musculoskeletal injuries in the ED can predict the short-term prognosis of recovery. The prediction is made at hospital discharge using a (-7/+7) numerical rating scale (-7=poor prognosis; 7=best prognosis).
- Conditions
- Musculoskeletal Diseases
- Being tested
- Standard care
- Keywords
- Minor Musculoskeletal Injuries, Emergency Department, Prediction outcome, Extended Scope Physiotherapists
- Medical subject headings
- Musculoskeletal Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
Treatment by an extended scope physiotherapist following Standard Operating Procedures.
| Study group | Role | What they receive |
|---|---|---|
| Caseload group | Not described Receives: Behavioral: Standard care | |
| Prediction group | Not described Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition ratings of global perceived effect
Using a transition questionnaire (TRANS-Q) the perceived effect of treatment will be measured by participants answering if their current health status is "unchanged", "worse" or "better" compared to their pre-injury status. "unchanged" equals a transition score of 0. If the participant answers "worse", he/she is asked to rate the degree of worsening on a 7 point Likert scale, with corresponding scores ranging from -1 to -7. If the participant answers "better", he/she is asked to rate the degree of improvement on a 7 point Likert scale, with corresponding scores ranging from 1 to 7. Thus the GPE score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
Measured: 1 month after discharge
Secondary outcomes (2)
Patient Acceptable Symptom State
Measured: 1 month after discharge
EuroQoL questionnaire
Measured: 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Aug 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- 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
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- Christian P Olsen, PT, Phd candidate, Principal investigator, Næstved-Slagelse-Ringsted HospitalsMarius Henriksen, PT, PhD, Study chair, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg HospitalSøren T Skou, PT, PhD, Study chair, Næstved-Slagelse-Ringsted Hospitals and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011917
- Sponsor's protocol ID
- REG-032-2019
- Status last verified
- Jan 2020
- First submitted
- 4 Jul 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04011917
- Acronym / sponsor ID
- REG-032-2019
- Conditions
- Musculoskeletal Diseases
- Keywords
- Minor Musculoskeletal Injuries, Emergency Department, Prediction outcome, Extended Scope Physiotherapists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 9 Jul 2019 (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.
This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital.
Patients treated by the ESP during a 3 month period will be included in this study.
Furthermore we aim to assess if ESPs treating patients with minor musculoskeletal injuries in the ED can predict the short-term prognosis of recovery. The prediction is made at hospital discharge using a (-7/+7) numerical rating scale (-7=poor prognosis; 7=best prognosis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caseload group | – | Behavioral: Standard care |
| Prediction group | – | Behavioral: Standard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated by an ESP physiotherapist in the emergency room at Slagelse Hospital, Denmark, in a 3 month period +1 month follow-up will be invited to participate in this study.
Key inclusion criteria (3 listed)
- 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
- 2 Has an email address
- 3 Signed informed consent form
Key exclusion criteria (2 listed)
- 1 A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., not having access to the internet, cognitive impairments etc.)
- 2 Under the influence of drugs or alcohol
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 |
|---|---|---|
| Standard careTreatment by an extended scope physiotherapist following Standard Operating Procedures. | Behavioural | Caseload group, Prediction group |
Primary outcome
Transition ratings of global perceived effect
Time frame: 1 month after discharge
Using a transition questionnaire (TRANS-Q) the perceived effect of treatment will be measured by participants answering if their current health status is "unchanged", "worse" or "better" compared to their pre-injury status. "unchanged" equals a transition score of 0. If the participant answers "worse", he/she is asked to rate the degree of worsening on a 7 point Likert scale, with corresponding scores ranging from -1 to -7. If the participant answers "better", he/she is asked to rate the degree of improvement on a 7 point Likert scale, with corresponding scores ranging from 1 to 7. Thus the GPE score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
2 secondary outcomes
Patient Acceptable Symptom State
Time frame: 1 month after discharge
EuroQoL questionnaire
Time frame: 1 month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Yes. Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.
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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.
Christian P Olsen, PT, Phd candidate principal investigator
Næstved-Slagelse-Ringsted Hospitals
Marius Henriksen, PT, PhD study chair
Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
Søren T Skou, PT, PhD study chair
Næstved-Slagelse-Ringsted Hospitals and University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases, run by Slagelse Hospital at 1 site in Denmark.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition ratings of global perceived effect (time frame: 1 month after discharge). 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 18 Jan 2020.