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:

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.
B: Inclusion Criteria:

1. Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
2. Age 18 - 60 years

Exclusion Criteria:

1. Serious spinal pathology

   1. Malignancy
   2. Osteoporosis,
   3. Fresh vertebral fracture
   4. Newly operation on the back
   5. Stenosis of the lumbar spine
   6. Unstable spondylolistesis
   7. Infections in the back
2. Neurological dysfunction of the thoracic or abdominal muscles
3. Pregnancy/breastfeeding
4. Mental illness
5. Health conditions which prohibit intensive training.
6. Languish problems/ dyslexia
C: 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
D: Inclusion Criteria:

* Patients currently receiving primary care at Portland VAMC
* Diagnosed musculoskeletal chronic pain condition lasting at least 3 months
* Currently experiencing moderate to severe symptoms as per screening
* Willingness to complete 6 and 12 month interviews
* Regular access to a telephone

Exclusion Criteria:

* Dementia or cognitive disturbance
* Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness
* Designated guardian
* Drug-seeking behavior flag in medical record

Answer: C