Condition category
Musculoskeletal Diseases
Date applied
05/05/2009
Date assigned
17/06/2009
Last edited
17/06/2009
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

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

http://www.reha-clinic.ch/cms/

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

Publication citations

Additional files

Editorial Notes