Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Brief Summary: Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.


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:

* age 18-56 years
* present employment at the company
* at least one criteria out the following qualified for the study:

  * nonspecific LBP with the duration of 2 weeks or more
  * radiating, present low back pain
  * recurrent LBP (2 or more episodes per year)
  * work absence because of LBP
* included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm)

According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more.

Exclusion Criteria:

* retirement
* acute nerve root compression symptoms
* malignant tumor
* recent fracture
* severe osteoporosis
* other specific disease preventing participation in the follow-up
C: Inclusion Criteria:

* Back/neck pain with or without headache for at least two weeks and at least three times per week
* Resident of Stockholm County
* Literate in Swedish
* Willing and able to comply with study requirements

Exclusion Criteria:

* Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
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