- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011917
Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Region Zealand
-
Slagelse, Region Zealand, Denmark, 4200
- The Emergency Department, Slagelse Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
- 2 Has an email address
- 3 Signed informed consent form
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Caseload group
|
Treatment by an extended scope physiotherapist following Standard Operating Procedures.
|
|
Prediction group
|
Treatment by an extended scope physiotherapist following Standard Operating Procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month after discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient Acceptable Symptom State
Time Frame: 1 month after discharge
|
1 month after discharge
|
|
EuroQoL questionnaire
Time Frame: 1 month after discharge
|
1 month after discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS Pain
Time Frame: At baseline and 1 month after discharge
|
The VAS pain is a measure of pain intensity, which has been widely used in diverse adult populations.
The scale is a unidimensional continuous scale comprised of a horizontal line, anchored by 2 verbal descriptors, one for each symptom extreme (0 no pain, 10 the worst imaginable pain).
|
At baseline and 1 month after discharge
|
|
Analgesic use
Time Frame: 1 month after discharge
|
The participants self-reported use of analgesics will be collected at the 1 month follow-up.
Participants will be asked to note their use of analgesic drugs, within the week before the follow-up, only related to the treated injury in the emergency room.
|
1 month after discharge
|
|
Follow-up treatments
Time Frame: 1 month after discharge
|
The participants self-reported use of follow-up visits with other allied health professionals will be recorded.
All visits related to the treated injury during the 1-month follow-up period should be noted.
|
1 month after discharge
|
|
Re-injury
Time Frame: 1 month after discharge
|
The participants self-reported reinjury rate during the 1-month follow-up period will be recorded.
|
1 month after discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian P Olsen, PT, Phd candidate, Næstved-Slagelse-Ringsted Hospitals
- Study Chair: Marius Henriksen, PT, PhD, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
- Study Chair: Søren T Skou, PT, PhD, Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-032-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Diseases
-
Al-Baha UniversityNot yet recruitingMusculoskeletal Disorders | Work-Related Musculoskeletal Disorders | Occupational Musculoskeletal Disorders
-
Cairo UniversityNot yet recruiting
-
Wake Forest University Health SciencesRecruitingMusculoskeletal InjuryUnited States
-
Wroclaw University of Health and Sport SciencesUniversity School of Physical Education, Krakow, PolandCompletedMusculoskeletal DisorderPoland
-
Laval UniversityCompletedMusculoskeletal DisorderCanada
-
Laval UniversityCompleted
-
Cairo UniversityNot yet recruiting
-
Norwegian University of Science and TechnologyNot yet recruitingSick Leave | MusculoskeletalNorway
-
Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
-
Imam Abdulrahman Bin Faisal UniversityCompletedWork Related Musculoskeletal DisordersSaudi Arabia
Clinical Trials on Standard care
-
University of LahoreRecruitingDiabetic Foot UlcerPakistan
-
Neuroscience Trials AustraliaNational Institute for Health Research, United Kingdom; Northern Ireland Chest... and other collaboratorsCompleted
-
Evandro Chagas Institute of Clinical ResearchAlejandro Marcel Hasslocher Moreno, MD MSc PhD student; Andrea Costa, MD PhD; Andrea Silvestre de Sousa, MD PhD and other collaboratorsUnknownChagas Heart DiseaseBrazil
-
Avita MedicalNAMSACompletedVenous Leg UlcersUnited Kingdom, France
-
University of MichiganCompleted
-
Indonesia UniversityCompletedCovid19 | AcupunctureIndonesia
-
The General Hospital of Western Theater CommandRecruitingMucositis | Hematopoietic Stem Cell Transplantation | Radiation-Induced Mucositis | Chemotherapy-Induced MucositisChina
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
Institut de Cancérologie de LorraineTerminatedBreast CancerFrance
-
brett rasmussenCompleted