Contact information
Type
Scientific
Primary contact
Mr Martin L Verra
ORCID ID
Contact details
Physiotherapy Institute
Inselspital
Bern University Hospital
Freiburgstrasse
Bern
3010
Switzerland
+41 (0)31 632 3956
martin.verra@insel.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A.
Study information
Scientific title
Effectiveness of tailored pain management in subgroups according to the three-cluster solution of the multidimensional pain inventory (MPI) in patients with chronic back pain in an inpatient rehabilitation setting: a randomised controlled trial
Acronym
RCT cBPsub
Study hypothesis
A combination of graded exercise therapy and cognitive behavioural therapy a priori matched to subgroups of patients based on the MPI with chronic non-specific back pain shows better short-term and long-term outcome than non-matched interventions.
Ethics approval
1. Ethics Committee of the Health Department in Aarau gave approval on the 6th February 2009 (ref: 2008/033)
2. Ethics Committee of the Health Department in Zurich gave approval on the 12th March 2009 (ref: 15/09)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic back pain
Intervention
The purpose of this randomised controlled trial is to examine the effectiveness of combinations of graded activity exercise (GA) with individual cognitive behavioural therapy (CBT) in subgroups of patients with chronic non-specific back pain (CNSBP) who are hypothesised to benefit from these treatments compared with similar persons who will receive strengthening and stretching exercises and CBT in a group setting. All subjects are participants in a four week inpatient pain management program and attend 20 physiotherapy sessions and 12 sessions with a clinical psychologist.
1. Control group: standard group therapies and individual physiotherapy (strength and stretching exercises)
2. Intervention group: standard group therapies and MPI-subgroup specific individual physiotherapeutic (graded activity exercise) and psychological (cognitive behavioural therapy or systemic therapy) interventions
Duration of treatment: 4 weeks inpatient rehabilitation. Booster sessions by telephone for the intervention group 3 and 7 weeks after discharge. Participants will be followed-up for 12 months after entry.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Self-reported functional disability (Oswestry Disability Index), measured at T0, T2, T3 and T6.
Timepoints:
T0: 4 weeks before entry
T1: entry to pain programme
T2: discharge from pain programme
T3: 3 months follow-up
T6: one year follow-up
Secondary outcome measures
1. Observed functional disability: the physical performance tests Back Performance Scale (BPS) and 5-Minute Walk Distance, measured at T1 and T2
2. Global perceived effect on daily functioning, measured at T2, T3 and T6
3. The Numeric Rating Scale (NRS) for pain, measured at T1, T2, T3 and T6
4. The subscales "Ability to decrease pain", and "Ability to control pain" of the Coping Strategies Questionnaire (CSQ), measured at T1, T2, T3 and T6
5. Mental health (Hospital Anxiety and Depression Scale [HADS]), measured at T1, T2, T3 and T6
6. Pain Catastrophising Scale (PCS), measured at T1, T2, T3 and T6
7. Treatment expectancy and credibility (Credibility/Expectancy Questionnaire [CEQ]), measured at T1
Timepoints:
T0: 4 weeks before entry
T1: entry to pain programme
T2: discharge from pain programme
T3: 3 months follow-up
T6: one year follow-up
Overall trial start date
01/01/2009
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Stationary patients of RehaClinic of at least 18 years old, either sex
2. Diagnosis of chronic back pain: at least 3 months of continuous back pain localised in the lumbar, thoracic, and/or cervical region
3. Willingness to learn behavioural patterns and motivation to participate in graded activity exercise programs
4. Ability to formulate realistic functional goals
5. Sufficient cognitive abilities and German language skills to understand the content of the interventions
6. Agreement to participate in the program and the assessment by written, signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 120 patients (across all arms and both study centres) will be recruited
Participant exclusion criteria
1. Severe somatic illness requiring specific treatment such as cancer, inflammatory rheumatic disease, neurological disease, pain after a recent operation (less than 6 months)
2. Specific back pain, defined as herniated disc, ankylosing spondylitis, spondylolisthesis, spinal fracture, or other relevant neurological diseases
3. Specific medical disorders and cardiovascular diseases, preventing participation at physical exercise
4. Pregnancy
5. Manifest psychiatric disorder such as dementia, psychosis, suicidality
6. Whiplash associated disorders
Recruitment start date
01/01/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Physiotherapy Institute
Bern
3010
Switzerland
Sponsor information
Organisation
Zurzach Rehabilitation Foundation SPA (Switzerland)
Sponsor details
Quellenstrasse
Bad Zurzach
5330
Switzerland
+41 (0)56 269 5151
a.aeschlimann@rehaclinic.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Zurzach Rehabilitation Foundation SPA (Switzerland)
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