Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.


Options:
A: Inclusion Criteria:

* Participants diagnosed with low back pain at least 3 months before the screening or washout period
* Participants who have taken a stable dose of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (drugs used for reducing inflammation and pain ) or Cyclo-Oxygenase 2 (COX-2) selective inhibitors (an anti-inflammatory drug that fights pain) from 7 days before investigational product administration, and could maintain the same dose during the period of the study
* Participants whose average pain intensity is more than or equal to 4.0 centimeters on Visual Analog Scale over the last 48 hours after the completion of screening
* Postmenopausal or surgically sterile or abstinent women or practicing a highly effective method of birth control
* Women with childbearing potential must have negative pregnancy test

Exclusion Criteria:

* Participants who have taken tramadol or tramadol HCl or acetaminophen, or narcotic (strong habit-forming drug that stops pain and depresses the central nervous system) analgesic tablet within 30 days before investigational product administration
* Participants who have taken acetaminophen tablet within 7 days before investigational product administration
* Participants with tumor or infection in meninges or spinal cord
* Participants who have fibromyalgia (neurosensory disorder characterized by muscle pain, joint stiffness, and fatigue), reflex sympathetic dystrophy (feeling of pain associated with evidence of minor nerve injury) or causalgia (persistent, severe burning sensation of the skin), acute spinal cord compression, acute nerve root compression, severe lower extremity weakness or numbness, regional pain syndrome, meningitis (inflammation of the meninges), diskitis (nonbacterial inflammation of an intervertebral disk or disk space), back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm
* Participants who have taken analgesic (including local agents or anesthetics), sedative-hypnotic (e.g., diazepam), or muscle relaxant other than a stable dose of NSAIDs or COX-2 selective inhibitors within 5 times the half-life of the concerned agent before investigational product administration
B: Inclusion Criteria:

* Present with duration of low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month). Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with certain protocol-defined limitations.
* Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh
* Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits
* Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study
* Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study

Exclusion Criteria:

* History of lumbosacral radiculopathy within the past 2 years.
* Back pain due to visceral disorder (eg, endometriosis).
* Back pain due to major trauma or osteoporotic compression fracture in the past 6 months.
* History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.
* Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study.
* Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years.
* Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline
* Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain.
* Patients taking \>325 mg/day of aspirin.
* Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs).
* Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period.
* Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted).
* Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months.
* Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.
* Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period.
* Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding.
* Current use of lithium or anticoagulant agents.
* Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.
* Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID.
* History of intolerance to acetaminophen or paracetamol or any of its excipients.
* History of known alcohol, analgesic or narcotic abuse within 2 years.
* Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
* Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception).
* Signs and symptoms of clinically significant cardiac disease.
* Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities.
* History of cancer within 5 years.
* Use of any investigational medication within 30 days (3 months for investigational biologics).
* Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period.
* Previous exposure to exogenous NGF or to an anti NGF antibody.
* Screening laboratory results and blood pressure within specified limits.
* Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening.
* History, diagnosis, or signs and symptoms of clinically significant neurological disease.
* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
* Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening.
* Likelihood of being non compliant with study procedures.
C: Inclusion Criteria:

* Active Duty
* Aged 18-35
* New episode of low back pain (LBP) or a reoccurence of a past episode of low back pain

Exclusion Criteria:

* LBP from other somatic tissues as determined by history, examination, and course (i.e. pain referred from visceral conditions)
* Radicular pain worse than back pain
* Co-morbid pathology or poor health conditions that may directly impact spinal pain. Patients who have case histories and physical examination findings indicating other than average health will be excluded from the study
* Bone and joint pathology contraindicating patient for M/MT. Patients with spinal fracture, tumors, infections, inflammatory arthropathies and significant osteoporosis will be referred for appropriate care and will be excluded from the study
* Other contraindications for M/MT of the lumbar spine and pelvis (i.e. bleeding disorders or anticoagulant therapy)
* Pregnancy (all potential female participants will undergo pregnancy testing)
* Use of manipulative care for any reason within the past month
* Unable to follow course of care for four weeks
* Unable to give informed consent for any reason
* Unable to confirm that they will not be deployed during the course of the study: "Will you be deployed, receiving orders for a distant temporary active duty assignment, attending training at a distant sight, or otherwise absent from Ft. Bliss over the next 6 weeks?"
D: Inclusion Criteria:

* Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
* age 18-70 years.

Exclusion Criteria:

* Osteoporosis
* Newly operation on the back up to 2 years before the beginning of the study
* Fresh vertebral fracture
* Malignancy
* Infection in the back
* spondylolisthesis
* Problem in understanding Farsi Language

Answer: A