Condition category
Musculoskeletal Diseases
Date applied
30/04/2005
Date assigned
10/06/2005
Last edited
05/10/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lobadis.nl/lobadis/study3/default.htm

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

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

No ethics information 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 measures

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

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

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16426449&query_hl=1&itool=pubmed_DocSum

Publication citations

  1. 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.

Additional files

Editorial Notes