A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug
      (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and
      tolerability of Theramine alone in patients with chronic back pain in comparison to the
      NSAID, Ibuprofen, and the co-administration of Ibuprofen with Theramine.
    

Detailed description: 
      The diagnosis and management of back pain is a challenge for both primary care physicians and
      specialists. Establishing an etiology can be difficult and often problematic, with treatment
      options capable of producing serious and potentially life threatening side effects.
      Treatments often exert a modest impact on the natural history of the condition. Non-steroidal
      anti-inflammatory drugs (NSAIDs) are frequently prescribed to treat chronic back pain. NSAIDs
      are only moderately effective in relieving pain. NSAIDs are the leading cause of drug-induced
      gastrointestinal bleeds, the most common cause of drug-induced morbidity and mortality
      particularly at high dose. They can also exacerbate hypertension, edema and produce
      nephrotoxicity. The effects are also dose dependent. Recent data indicates NSAIDs are a risk
      factor for myocardial infarction, particularly at high doses. Recent data also indicates
      NSAIDs disrupt collagen repair in injured tissue. Muscle relaxants and narcotic analgesics
      show limited efficacy and often produce sedation, constipation or inappropriate usage.
      Physical therapy and local modalities often are not satisfying, costly, and require
      considerable investment of patient time.

      Neurotransmitter depletion has been demonstrated to contribute to chronic pain states.
      Increased nutrient requirements associated with pain syndromes and the consequent reduced
      production of neurotransmitters contribute to maladaptive pain responses. The ability to
      enhance neurotransmitter production associated with pain syndromes is limited by multiple
      factors, specifically unavailability of adequate essential amino acids in the diet and
      increased turnover rates of amino acids needed to produce neurotransmitters in pain
      syndromes. Other factors such as prolonged pharmaceutical use deplete the nerve cells of
      neurotransmitters. Attempts to modify brain neurochemistry have focused on single
      neurotransmitters such as serotonin or GABA. However, this approach fails to address the
      complexity and complementary influences of multiple neurotransmitters on patient perception
      of pain and suffering.

      Theramine is a proprietary prescription Medical Food which concurrently enhances several
      neurotransmitters that are involved in pain modulation and sensation by providing
      neurotransmitter precursors in the form of amino acids, (see attached Monograph for detailed
      discussion). Small trials have found Theramine effective in reducing and modifying pain
      without demonstrable side effects. Theramine simultaneously stimulates the production of the
      neurotransmitters serotonin, GABA, brain induced cortisol, nitric oxide, and glutamate.
    

Intervention name(s): Theramine (A medical food); Theraprofen; Ibuprofen
Intervention type(s): Other; Drug; Drug
Intervention description(s): Theramine two capsules twice daily for 28 days.; Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.; Ibuprofen 400mg once daily for 28 days.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Medical food; Theramine; Ibuprofen; Amino acids; Convenience Pack Kit