Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain
Brief Summary: Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.


Options:
A: Inclusion Criteria:

* Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
* Age 18 - 60 years
* Oswestry disability score \> 20%
* Both of the following clinical decision rule criteria: a)Duration of current symptoms \< 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.

Exclusion Criteria:

* Prior surgery to the lumbosacral spine
* Any treatment for low back pain in past 6 months
* Current pregnancy
* Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
* Presence of neurogenic LBP defined as the presence of either of the following:

  a) Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at \<45 degrees); or b)Reflex, sensory, or strength deficits in a pattern consistent with lumbar nerve root compression
* Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection or systemic disease
B: Inclusion Criteria -

* Military personnel on active duty and eligible for healthcare at a military treatment facility
* A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
* Duration of current episode of low back pain \< 90 days
* Age 18 - 60 years (or emancipated minors on active duty)
* Available for the following 4 weeks to complete a regimen of treatment

Exclusion Criteria:

* Oswestry Disability Index \< 20%
* History of receiving any medical care for this episode of low back pain within the last 3 months
* Prior surgery to the thoraco-lumbar spine or pelvis
* This episode of back pain is due to a traumatic fracture
* Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
* Any "red flags" that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease.
* Current episode occurred because of a motor vehicle accident
* Currently pregnant (or history of pregnancy in the previous 6 months)
C: Inclusion Criteria:

* to be suffering from low back pain (LBP) for a period of less than 6 weeks (with or without leg pain) that had limited one's activities or changed the daily routine for more than a day,
* to have been pain free for at least 3 months before the onset of the current LBP episode.

Exclusion Criteria:

* "red flag" signs that may suggest serious spinal pathology,
* history of spinal surgery,
* obvious lower limb radiculopathy
* fibromyalgia
* rheumatoid arthritis
* important skin lesion in the lumbar area
* alteration of cutaneous sensations or temperature perception
* being pregnant of trying to become
D: Inclusion Criteria:

* Modified Oswestry Disability Index (ODI) ≥ 20%
* Numeric Pain Rating Scale (NPRS) of ≥ 2 points
* Primary complaint of low back pain with at least one hip impairment in one or both hips

Exclusion Criteria:

* Contraindications to manual therapy
* Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
* 'Red flag' symptoms including:

  * Tumor
  * Metabolic disease
  * Rheumatoid arthritis or other systemic rheumatologic disorders
  * Acute fracture
  * Bowel/Bladder dysfunction
  * Prolonged history of corticosteroid use
  * Evidence of central nervous system involvement
* Two or more positive neurologic signs consistent with nerve root compression:

  * Diminished muscle stretch reflexes of lower extremity
  * Muscle weakness in any lower extremity myotome
  * Diminished or absent sensation in any lower extremity dermatome
* Spinal surgery in the last 6 months
* Total Hip Arthroplasty
* Currently pregnant or post-partum ≤ 6 months
* Osteoporosis
* History of cancer within the last 12 months
* Inability to understand the English language

Answer: A