A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
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.
Chronic Low Back Pain
Other: Theramine (A medical food)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain|
- Roland-Morris Lower Back Pain Scale [ Time Frame: 28 Days ] [ Designated as safety issue: No ]The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Roland-Morris Lower Back Pain.
- Visual Analog Scale Evaluation [ Time Frame: 28 days ] [ Designated as safety issue: No ]The primary efficacy outcome will be the change from baseline in awakening stiffness and pain subscale scores obtained from the Visual Analog Scale Evaluation.
- Oswestry Low Back Pain Scale [ Time Frame: 28 Days ] [ Designated as safety issue: No ]Functionality outcomes obtained from the Oswestry Low Back Pain Scale
- C-reactive protein [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]Percent change in c-reactive protein levels from baseline to Day 28.
- Interleukin-6 [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]Percent change in Il-6 level from baseline to Day 28.
- Amino Acid Panel [ Time Frame: 28 Days ] [ Designated as safety issue: No ]Change in amino acid turnover rate from baseline to Day 28.
|Study Start Date:||September 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Theramine active and ibuprofen placebo
2 capsules Theramine twice daily with one ibuprofen-like placebo once daily.
Other: Theramine (A medical food)
Theramine two capsules twice daily for 28 days.
Active Comparator: Theramine and Ibuprofen (Theraprofen)
Two capsules Theramine twice daily with Ibuprofen 400mg once daily.
Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.
Active Comparator: Theramine placebo and Ibuprofen
Two Theramine-like placebo twice daily and one ibuprofen 400mg.
Ibuprofen 400mg once daily for 28 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490905
|United States, California|
|Targeted Medical Pharma|
|Los Angeles, California, United States, 90077|