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(Cost-)effectiveness of a physical, a cognitive-behavioural and an integrated treatment in chronic low back pain disability

(Cost-)effectiveness of a physical, a cognitive-behavioural and an integrated treatment in chronic low back pain disability: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22714229
Enrollment
223
Registered
2005-06-10
Start date
2002-04-01
Completion date
Unknown
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-specific chronic low back pain Musculoskeletal Diseases Back pain

Interventions

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

Sponsors

Netherlands Organisation for Health Research and Development (ZonMw)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Roland Disability Questionnaire (RDQ)

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026