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Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department

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ClinicalTrials.gov Identifier: NCT04011917
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Slagelse Hospital

Brief 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.

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).


Condition or disease Intervention/treatment
Musculoskeletal Diseases Behavioral: Standard care

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Study Type : Observational
Actual Enrollment : 432 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 15, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Group/Cohort Intervention/treatment
Caseload group Behavioral: Standard care
Treatment by an extended scope physiotherapist following Standard Operating Procedures.

Prediction group Behavioral: Standard care
Treatment by an extended scope physiotherapist following Standard Operating Procedures.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Acceptable Symptom State [ Time Frame: 1 month after discharge ]
  2. EuroQoL questionnaire [ Time Frame: 1 month after discharge ]

Other Outcome Measures:
  1. 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).

  2. 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.

  3. 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.

  4. Re-injury [ Time Frame: 1 month after discharge ]
    The participants self-reported reinjury rate during the 1-month follow-up period will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011917


Locations
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Denmark
The Emergency Department, Slagelse Hospital
Slagelse, Region Zealand, Denmark, 4200
Sponsors and Collaborators
Slagelse Hospital
Bispebjerg Hospital
Investigators
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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
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Responsible Party: Slagelse Hospital
ClinicalTrials.gov Identifier: NCT04011917    
Other Study ID Numbers: REG-032-2019
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Slagelse Hospital:
Minor Musculoskeletal Injuries
Emergency Department
Prediction outcome
Extended Scope Physiotherapists
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Emergencies
Disease Attributes
Pathologic Processes