Effectiveness of tailored pain management in patients with chronic back pain

ISRCTN ISRCTN25592008
DOI https://doi.org/10.1186/ISRCTN25592008
Secondary identifying numbers N/A.
Submission date
05/05/2009
Registration date
17/06/2009
Last edited
17/06/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Martin L Verra
Scientific

Physiotherapy Institute
Inselspital, Bern University Hospital
Freiburgstrasse
Bern
3010
Switzerland

Phone +41 (0)31 632 3956
Email martin.verra@insel.ch

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness 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
Study acronymRCT cBPsub
Study objectivesA 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(s)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)
Health condition(s) or problem(s) studiedChronic back pain
InterventionThe 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 typeOther
Primary outcome measureSelf-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 measures1. 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 study start date01/01/2009
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA total of 120 patients (across all arms and both study centres) will be recruited
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2009
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Physiotherapy Institute
Bern
3010
Switzerland

Sponsor information

Zurzach Rehabilitation Foundation SPA (Switzerland)
Research organisation

Quellenstrasse
Bad Zurzach
5330
Switzerland

Phone +41 (0)56 269 5151
Email a.aeschlimann@rehaclinic.ch
Website http://www.reha-clinic.ch/cms/

Funders

Funder type

Research organisation

Zurzach Rehabilitation Foundation SPA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan