Contact information
Type
Scientific
Primary contact
Dr Carin Ottosson
ORCID ID
Contact details
Ortopediska kliniken
Södersjukhuset
Stockholm
118 83
Sweden
carin.ottosson@sodersjukhuset.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We hypothesised that in patients with combinations of risk factors for a protracted course, a multidisciplinary intervention with information about the injury, pain management and activity level, and support of healthy instead of illness behaviour, during the acute phase of rehabilitation might shorten the time to recovery.
The objective of this study was to assess the efficacy of such an intervention in patients with acute traffic related minor musculoskeletal injuries, rated to be at high risk for delayed recovery, based on the scores obtained in a newly developed prediction ruler (Prediction of Prolonged Self-perceived recovery after musculoskeletal injuries [PPS]).
Ethics approval
The study was approved by the local Ethics Committee, the Karolinska Institute, on the 11th June 2001 (reference number: 240/01).
Study design
Randomised Controlled Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Traffic related minor musculoskeletal injuries
Intervention
Eligible patients were randomised to an intervention or a control group. Both groups received standard medical treatment according to the routines at the department.
The intervention (multidisciplinary treatment) group also received the following program: A team consisting of an orthopaedic surgeon (study doctor), an anaesthetist specialised in pain treatment, physiotherapist, study nurse and a psychologist carry out the intervention program consisting of group "lectures" where different topics are highlighted.
The aim of this "traffic injury school" is to, in a systematic and supportive manner, provide an information and discussion forum for topics that are relevant to all study patients regardless of the type of injury. The program consists of four short (about two hours) sessions once a week during a four-week period. The first lecture consists of an introduction to the program and a discussion about different coping mechanisms. The following three lectures deal with issues related to pain and pain treatment, the importance of physical training, how fractures and soft tissue injuries heal, and the interaction between mental and physical health.
All sessions are lead by the study doctor, anaesthetist, physiotherapist or psychologist and the study nurse participates in all sessions. After the introduction session the patients may participate in consecutive sessions or they can choose to come to later sessions as the groups are "open" and the "school" runs on a three week rolling schedule. After every session the patients rate their "control over the situation". If the patient is in need of individual treatment (orthopaedic surgeon, physiotherapist, psychologist) an appointment can be arranged by the hospital.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome measure was the patients self-perceived recovery at 12 months measured by the single question: "Do you feel recovered after the injury?" (yes/no).
Secondary outcome measures
Secondary outcome measures were:
1. The Short Form health survey (SF-36)
2. The Short Musculoskeletal Function Assessment (SMFA)questionnaire
3. The Visual Analogue Scale (VAS) ratings regarding physical and mental distress and coping ability
4. Self-reported duration of sick leave
Overall trial start date
01/09/2002
Overall trial end date
31/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Potentially eligible patients had sustained traffic related minor musculoskeletal injuries (Injury Severity Scale [ISS] score less than nine) less than 24 hours before arrival to the emergency department. Consecutive patients were evaluated, but to be eligible for randomisation the patients had to have a high risk of prolonged recovery according to the PPS Questionnaire.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
135
Participant exclusion criteria
1. A major musculoskeletal injury (ISS more than nine)
2. Aged over 18 years
3. Inability to read and understand spoken Swedish
4. Impaired cognitive function as judged by the investigators
Recruitment start date
01/09/2002
Recruitment end date
31/01/2004
Locations
Countries of recruitment
Sweden
Trial participating centre
Ortopediska kliniken
Stockholm
118 83
Sweden
Sponsor information
Organisation
Karolinska Institutet (Sweden)
Sponsor details
Department of Clinical Science and Education
Södersjukhuset
Stockholm
118 83
Sweden
sari.ponzer@sodersjukhuset.se
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
This study was supported by grants from:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AFA Reseach foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancer & Traffic injury fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Försäkringsmedicinska Sällskapet.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
These grants have been directed solely to Department of Orthopaedics, Karolinska Institutet at Stockholm Söder Hospital. The funders had no involvement in the study.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
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Results
Ottosson C, Pettersson H, Johansson SE, Nyrén O, Ponzer S, Recovery after minor traffic injuries: a randomized controlled trial., PLoS Clin Trials, 2007, 2, 3, e14, doi: 10.1371/journal.pctr.0020014.