Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation Program in Patients With Chronic Low Back Pain and Degenerative Disc. A Prospective Randomized Clinical Multicentre Trial.
Brief Summary: Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services. At present, ongoing randomized studies in both Europe and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have compared TDR to non-surgical treatment. The aim of the present study is to evaluate the effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients with chronic low back pain and localized degenerative disc changes.

Main hypothesis: There is no difference in treatment effect between surgery with lumbar total disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry Disability Index after 1 and 2 years.

Secondary hypothesis: There is no difference in cost - effectiveness between surgery with lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.


Options:
A: Inclusion Criteria:

* Low back pain as the main symptom for at least one year.
* Structured physiotherapy or chiropractic treatment for at least 6 months without (significant) effect.
* Oswestry Disability Index score of 30% points or more
* Degenerative changes in the intervertebral disc in one or both of the two lowest levels of the lumbar spine (L4/L5 and/or L5/S1). (Degenerative changes are classified based on MR findings according to the following criteria: At least 40% reduction of disc height, Modic changes type I and/or II, "High intensity zone" in the disc, Morphological changes classified as changes in signal intensity in the disc. To classify the disc as degenerative the first criteria alone or at least two of the other criteria must be present. The MR series are evaluated by two independent observers.)

Exclusion Criteria:

* Generalized chronic pain syndrome (widespread myofascial pain)
* Degeneration established in more than two levels. To be classified as a normal disc, the disc height must not be reduced more than 40% and all other criteria of degenerative disc disease aforementioned must be absent. The classification of a normal disc is performed by two independent observers. If disagreement, the pictures will be classified by a third observer and the outcome decided by simple majority.
* Symptoms of spinal stenosis
* Disc protrusion or recess stenosis with nerve root affection
* Spondylolysis
* Isthmic spondylolisthesis
* Arthritis
* Former fracture of L1 - S1
* Ongoing psychiatric or somatic disease that excludes either one or both treatment alternatives
* Does not understand Norwegian language, spoken or in writing
* Drug abuse
* Osteoporosis
* Congenital or acquired deformity
B: Inclusion Criteria:

1. Working age up to and including 59 years.
2. Sick-listed full-time for BNP for at least 42 days and at most 730 days.
3. Able to manage tolerably well to fill in forms.

Exclusion Criteria:

1. Temporary disability pension or disability pension being paid or in preparation.
2. A primary need of action by a hospital specialist.
3. Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
4. Whiplash-associated disorders as a primary obstacle to working.
5. Previous rehabilitation at the rehabilitation centre.
6. Other multidisciplinary rehabilitation going on or planned.
C: Inclusion Criteria:

* Quebec Task Force Spinal Disorders (QTFSD) classification of 1a: acute low back pain without pain radiation below the gluteal fold
* QTFSD classification of 1b and 1c: subacute and chronic low back pain without pain radiation below the gluteal fold
* QTFSD classification of 2a: acute low back pain with pain radiation to the knee
* QTFSD classification of 2b and 2c: subacute and chronic low back pain with pain radiation to the knee
* QTFSD classification of 3a, 3b, or 3c: acute, subacute, or chronic low back pain with pain radiation below the knee
* Can read and speak English
* Parent or guardian willing to provide informed consent if applicable

Exclusion Criteria:

* QTFSD classification of 4a, 4b, or 4c: acute, subacute, or chronic low back pain with pain radiation below the knee and experiencing neurological symptoms
* QTFSD classification of 5: likely lumbar nerve root compression
* QTFSD classification of 6: confirmed lumbar nerve root compression
* QTFSD classification of 7: confirmed lumbar spinal stenosis
* QTFSD classification of 8: less than 6 months after surgery for back pain
* QTFSD classification of 9.1: more than 6 months after surgery for back pain and not experiencing any symptoms
* QTFSD classification of 11: other spinal disorders including cancer, disease inside bone, or fracture
D: Inclusion Criteria:

* fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

* physical or psychological comorbidity that interferes with cognitive-behavioral treatment
* participation in other clinical trials
* other psychological treatments
* pregnancy
* illiteracy
* difficulties with understanding Dutch language

Answer: A