Effectiveness of tailored pain management in patients with chronic back pain

ISRCTN	ISRCTN25592008
DOI	https://doi.org/10.1186/ISRCTN25592008
Protocol serial number	N/A.
Sponsor	Zurzach Rehabilitation Foundation SPA (Switzerland)
Funder	Zurzach Rehabilitation Foundation SPA (Switzerland)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	RCT cBPsub
Study objectives	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(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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Switzerland

Study participating centre

Physiotherapy Institute

Bern
3010
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes