Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/09/2006
Date assigned
22/09/2006
Last edited
10/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://ki.se/

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17380190

Publication citations

  1. 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.

Additional files

Editorial Notes