Contact information
Type
Scientific
Primary contact
Prof Thomas Kohlmann
ORCID ID
Contact details
Walther Rathenau Str. 48
Greifswald
17475
Germany
thomas.kohlmann@uni-greifswald.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of a risk tailored intervention among low back pain patients in primary care: a cluster randomised controlled trial
Acronym
Study hypothesis
To assess the effectiveness of a risk tailored intervention among low back pain patients in primary care in improving patient outcomes.
Primary hypothesis:
The risk tailored intervention is more effective in reducing disability compared to treatment as usual.
Ethics approval
1. Ethics Committee of the Medical Faculty, University of Greifswald approved on the 2nd October 2008
2. Ethics Committee of the Medical Faculty, University of Göttingen approved on the 21st January 2009
Study design
Cluster randomised controlled trial, two treatment arms
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low back pain without specific origin
Intervention
The intervention consists of two elements:
1. A risk-factor screening and risk tailored educational intervention including information and counselling
2. A telephone/email consulting service concerning back pain related problems independent of risk group assignment
Both elements will be described subsequently:
Risk screening:
All patients fill out a brief risk screening inventory concerning yellow flags that are predictive of chronic back pain. Based on the results patients will be assigned to one of three risk groups (low/intermediate/high).
The tailored interventions are based on the risk factor assignment as follows:
1. Low level risk: patients receive advice on staying active by the general practitioner and will be handed an educational booklet. This booklet aims at reducing erroneous back related beliefs and fosters active health related behaviours. It argues against a biomechanical model by emphasising psychological and social aspects of back problems. Patients receive information regarding local health activities promoting physical exercise, sports, relaxation.
2. Physical risk group: in addition to the physicians' advices and the back book patients in will be offered participation in a guideline based intervention group that consists of two meetings of 120 minutes duration each. The main focus of these manualised meetings will be: education on "back myths" and risk factors, relaxation techniques, and motivation to stay active. Training selected physical exercises is a key element of these meetings. The groups will be conducted by experienced physiotherapists, and exercise therapists. The group size is limited to ten patients.
3. Psychological risk group: patients will receive physicians' advice and the back book. In addition, they will be invited to participate in a psychosocial risk factor group that comprises two additional meetings of 120 minutes duration each. These meetings will be conducted by psychologists with a specialisation in pain treatment. Patients receive a manualised cognitive-behavioural intervention that focusses on pain and strain prone situations as well as on catastrophising, depressive, and fear-avoidant cognitions. The group size is limited to five patients.
4. Combined physical and psychological risk group: patients will receive physicians' advice, the back book and an invitation to particiapte in both intervention groups as described above.
An attendance list will be taken for every course to monitor compliance. Patients receive an illustrated handbook designed specifically for the purpose of this trial with information on all covered topics. All therapeutic sessions will be structured based on a written manual. All participating therapists will have attended a training session of four hours.
Telephone, email counselling:
It is the aim of this counseling offer to answer back pain related questions that usually cannot be handled during a normal consultation. Local study coordinators (usually physiotherapists) will take on enquiries and pass them on to the collaborating MDs, psychologists, and sport scientists, as best suited. No diagnoses will be made during these contacts, neither will there be concrete therapeutic recommendations. A manual will be authored to standardise responses given during the telephone/email counselling.
This trial is carried out in cooperation with:
Gabriele Lindena
Clara Institut
Clara Zetkin Str. 34
14532 Kleinmachnow
Michael Pfingsten
Schmerzambulanz
Universitätsklinikum Göttingen
Robert-Koch Str. 40
37075 Göttingen
Ulf Marnitz
Rückenzentrum am Markgrafenpark
Markgrafenstr. 19
10969 Berlin
Jean-Francois Chenot
Abtlg. Allgemeinmedizin
Universität Göttingen
Humboltallee 38
37073 Göttingen
Ulrich Schwantes
Institut f. Allgemeinmedizin Charite
Schumannstr. 20/21
101177 Berlin
Klaus Pfeifer
Institut für Sportwissenschaft
Universität Erlangen
Gebertstr. 123 b
91508 Erlangen
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Functional disability as measured with the Hanover Functional Ability Questionnaire
2. Days of sick leave (over a 3-month recall period)
Secondary outcome measures
Patients' characteristics as measured by a questionnaire:
1. Graded chronic pain (Graded Chronic Pain Scale [GCPS])
2. Depression (Patient Health Questionnaire, German version [PHQ-D])
3. Quality of life (PHQ-D, 12-item short form [SF-12])
4. Fear Avoidance Beliefs Questionnaire (FABQ)
5. Physical activity
6. Catastrophising (Fatigue Severity Scale [FSS])
7. Health services utilisation
All measures will be assessed at baseline and, 6 and 12 months after inclusion in the study. Additionally, participation in the counselling groups and telephone/email contacts will be documented.
Overall trial start date
16/03/2009
Overall trial end date
30/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
General Practitioners (GPs) in Göttingen and within 20 minutes driving distance of the study centre and Berlin (less than 15 km distance from the study centre) are invited to take part in the trial by letter. Addresses were obtained from the local health boards. In case of non-response to the letter, GPs are contacted by telephone or personally.
The GPs recruit patients according to the following inclusion criteria:
1. Men and women aged 20 - 60 years
2. Consultation for low back pain
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 GPs, 1200 patients
Participant exclusion criteria
Patient:
1. Severe comorbidities (e.g. congestive heart failure, tumour)
2. Back pain of specific origin
3. Insufficient German language proficiency
4. Ongoing juridical proceedings due to pension claims
5. Prior spine surgery
6. Ongoing specialised pain treatment
7. Rehabilitation because of back pain in the past five years
Recruitment start date
16/03/2009
Recruitment end date
30/03/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Walther Rathenau Str. 48
Greifswald
17475
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Hannoversche Strasse 28-30
Berlin
10115
Germany
pt-info@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01EM0113)
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
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20051119
Publication citations
-
Protocol
Schmidt CO, Chenot JF, Pfingsten M, Fahland RA, Lindena G, Marnitz U, Pfeifer K, Kohlmann T, Assessing a risk tailored intervention to prevent disabling low back pain--protocol of a cluster randomized controlled trial., BMC Musculoskelet Disord, 2010, 11, 5, doi: 10.1186/1471-2474-11-5.