Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rob Smeets
ORCID ID
Contact details
Rehabilitation Centre Blixembosch
P.O. Box 1355
Eindhoven
5602 BJ
Netherlands
+31 (0)40 2642878
rsmeets@iae.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
014-32-007
Study information
Scientific title
(Cost-)effectiveness of a physical, a cognitive-behavioural and an integrated treatment in chronic low back pain disability: a randomised controlled trial
Acronym
Lobadis 3
Study hypothesis
The treatment of non-specific chronic low back pain (CLBP) is often based on different models regarding the maintenance of pain and disability:
1. Loss of muscle strength and endurance including aerobic capacity (physical deconditioning model)
2. Avoidance of activity due to learning, cognitive processes and environmental influences (cognitive behavioral model)
3. The combination of both models (biopsychosocial model)
Four differing treatments were developed:
1. Active Physical Treatment (APT)
2. Cognitive-Behavioural Treatment (CBT)
3. Combination Treatment consisting of APT plus CBT (CT)
4. Waiting List control group (WL)
It is hypothesised that:
1. All three active treatments are more effective in reducing low back pain disability than a waiting list control treatment (short term analysis)
2. CT is more effective and cost-effective than APT and CBT
Additional research questions are:
1. Does deconditioning exist in CLBP-patients?
2. What factors mediate the decrease in outcome (especially the effect of pain catastrophising and internal control of pain will be investigated)
3. Can prognositic factors for each of the treatments be identified?
4. Do physiological and psychological factors that are often described as very important, influence the level of performance in CLBP-patients?
5. Psychometric research on the Roland Disability Questionnaire and Quebec Back Pain Disability Scale (stabilility and responsiveness)
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Non-specific chronic low back pain
Intervention
Active Physical Treatment (APT):
Cardiovascular and leg/back extending muscle strengthening (three sessions/week for ten weeks)
Cognitive-Behavioural Treatment (CBT):
Combination of graded activity of patient relevant activities and problem solving training (19 and ten sessions in ten weeks respectively)
Combination Treatment (CT):
Combination of APT and CBT in the same frequency
Waiting List (WL):
After ten weeks of no treatment regular rehabilitation treatment is offered
Post-treatment WL will be compared to APT, CBT and CT. Also, CT will be compared to APT and CT. Six and 12 months post-treatment CT will be compared to APT and CBT.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Roland Disability Questionnaire (RDQ)
Secondary outcome measures
1. Three patient specific main complaints by using the patient specific approach method (Tugwell et. al.)
2. Current pain by using the Visual Analogue Scale (VAS) for pain at this moment
3. Pain Rating Index (total score) of the McGill Pain Questionnaire
4. Beck Depression Inventory
5. Patients global assessment of overall result measured by a transitional seven-point ordinal scale (1 = vastly worsened, 7 = completely recovered)
6. Treatment satisfaction by using VAS for the overall treatment provided to the patient
7. Six performance tests:
a. five minutes walking (meters)
b. fifty foot walking (seconds)
c. five times sit to stand, performed twice and average time needed to perform a series of five times is calculated (seconds)
d. loaded forward reaching by holding a stick with a weight of 2.25 or 4.5 kg in front of the body at shoulder height and extend as far as possible (centimeters)
e. one minute stair climbing (number of stairs)
f. Progressive Isoinertial Lifting Evaluation (PILE)-test weight lifting from floor to waist
Overall trial start date
01/04/2002
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients for the first time referred to three outdoor rehabilitation centers in the Netherlands
2. Age between 18 and 65 years
3. Non specific CLBP with or without irradiation to leg for more than three months resulting in disability (Roland Morris Disability score more than three)
4. Ability to walk at least 100 m without interruption
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
223
Participant exclusion criteria
1. Vertebral fracture
2. Spinal inflammatory disease
3. Spinal infections or malignancy
4. Current nerve root pathology
5. Spondylolysis or -listhesis
6. Lumbar spondylodesis
7. Medical co-morbidity making intensive exercising impossible (e.g. cardiovascular or metabolic disease)
8. Ongoing diagnostic procedures or treatment for their CLBP at the time of referral
9. Not proficient in Dutch
10. Pregnancy
11. Substance abuse that could intervene with the rehabilitation treatment
12. Patients have to stop other therapies except pain medication for their back complaints
13. The Symptom Checklist (SCL-90) and the Dutch Personality Questionnaire (NPV) are used to check for psychopathology that would hamper individual or group processes
Recruitment start date
01/04/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Rehabilitation Centre Blixembosch
Eindhoven
5602 BJ
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Sponsor details
Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
,950 Euro funded by Netherlands Organisation for Health Research and Development (ZonMw) (014-32-007)
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
Basic results (scientific)
Publication list
2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16426449
Publication citations
-
Results
Smeets RJ, Vlaeyen JW, Hidding A, Kester AD, van der Heijden GJ, van Geel AC, Knottnerus JA, Active rehabilitation for chronic low back pain: cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229]., BMC Musculoskelet Disord, 2006, 7, 5, doi: 10.1186/1471-2474-7-5.