(Cost-)effectiveness of a physical, a cognitive-behavioural and an integrated treatment in chronic low back pain disability
| ISRCTN | ISRCTN22714229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22714229 |
| Secondary identifying numbers | 014-32-007 |
- Submission date
- 30/04/2005
- Registration date
- 10/06/2005
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rob Smeets
Scientific
Scientific
Rehabilitation Centre Blixembosch
P.O. Box 1355
Eindhoven
5602 BJ
Netherlands
| Phone | +31 (0)40 2642878 |
|---|---|
| rsmeets@iae.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | (Cost-)effectiveness of a physical, a cognitive-behavioural and an integrated treatment in chronic low back pain disability: a randomised controlled trial |
| Study acronym | Lobadis 3 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 223 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rehabilitation Centre Blixembosch
Eindhoven
5602 BJ
Netherlands
5602 BJ
Netherlands
Sponsor information
Netherlands Organisation for Health Research and Development (ZonMw)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
,950 Euro funded by Netherlands Organisation for Health Research and Development (ZonMw) (014-32-007)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/01/2006 | Yes | No |
Editorial Notes
04/10/2017: internal review.
