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ISRCTN
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ISRCTN23549738
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ClinicalTrials.gov identifier
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Public title
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A multidisciplinary group intervention program to promote recovery after minor traffic injuries: a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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]).
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Lay summary
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Ethics approval
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The study was approved by the local Ethics Committee, the Karolinska Institute, on the 11th June 2001 (reference number: 240/01).
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Study design
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Randomised Controlled Trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Traffic related minor musculoskeletal injuries
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2002
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Anticipated end date
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31/01/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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135
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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
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Sources of funding
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This study was supported by grants from:
1. AFA Reseach foundation
2. Cancer & Traffic injury fund
3. Försäkringsmedicinska Sällskapet.
These grants have been directed solely to Department of Orthopaedics, Karolinska Institutet at Stockholm Söder Hospital. The funders had no involvement in the study.
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17380190
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Contact name
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Dr
Carin
Ottosson
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Address
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Ortopediska kliniken
Södersjukhuset
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City/town
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Stockholm
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Zip/Postcode
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118 83
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Country
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Sweden
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Email
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carin.ottosson@sodersjukhuset.se
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Sponsor
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Karolinska Institutet (Sweden)
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Address
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Department of Clinical Science and Education
Södersjukhuset
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City/town
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Stockholm
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Zip/Postcode
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118 83
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Country
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Sweden
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Email
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sari.ponzer@sodersjukhuset.se
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Sponsor website:
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http://ki.se/
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Date applied
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04/09/2006
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Last edited
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10/05/2007
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Date ISRCTN assigned
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22/09/2006
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