Distal Peripheral Neuropathy in Type 2 Diabetes
Condition: Peripheral Neuropathy; Pain, Neuropathic; Diabetes
MeSH terms: Peripheral Nervous System Diseases; Neuralgia
Study type: Interventional

Summary: 
      Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition
      affecting quality of life in persons living with Type 2 diabetes. Treatments prescribed to
      manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and
      anticonvulsants, are largely ineffective. This is a preliminary study at assessing the
      feasibility, efficiency and preliminary efficacy of a novel non-pharmacologic pain management
      approach, moxibustion, to reduce DSP pain and improve quality of life.
    

Detailed description: 
      Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition
      affecting quality of life in persons with Type 2 diabetes mellitus (T2DM). According to the
      Centers for Disease Control (CDC), 29 million Americans are living with T2DM. Treatments
      prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants
      and anticonvulsants, are largely ineffective. Effective management of DSP pain is an unmet
      therapeutic need for this population.

      This is a randomized, blinded, placebo-controlled clinical trial to determine feasibility and
      preliminary efficacy of Moxibustion (Moxa) for persons with T2DM DSP lower limb
      pain/discomfort. Participants with lower limb DSP pain/discomfort are randomized to one of
      four Conditions: 1) Traditional Moxa, 2) Smokeless Moxa 3) Placebo Moxa (control), or 4)
      WaitList (control). Participation involves a preliminary phone screening, provider
      verification of medical condition, intake baseline session, neurologicial evaluations,
      treatment sessions and follow ups. Participants assigned to the moxibustion conditions will
      be blind to treatment assignment, attend a screening session, followed by twice-weekly
      treatment sessions for 3 weeks, complete the same instruments and submit prospective symptom
      diaries (SD). Subjects randomized to the WaitList control condition experience all aspects of
      study participation with the exception of receiving moxibustion (during the study). They
      undergo all screening and eligibility assessments; attend study visits; submit and review
      their symptom diaries, update concomitant medication, complete assessment instruments;
      receive neuro/NST assessments and compensation. In all respects, participants in the Control
      groups receive the same concern as subjects assigned to the other groups. All moxibustion
      interventions will be implemented by licensed acupuncturists.
    

Intervention name(s): Moxibustion - Traditional (Active); Moxibustion - Smokeless - (Active); Placebo Moxibustion
Intervention type(s): Other; Other; Other
Intervention description(s): Traditional Moxibustion (Moxa) is a technique in which the herb, artemisia, in a cigar shape (pole moxa) is lit (burned) and applied over specific acupuncture points which follows a specific protocol aimed at reducing neuropathic lower limb pain/discomfort.; Smokeless Moxibustion uses the same technique as traditional moxa however, the moxa is smokeless. Smokeless moxa allows for use in a broad range of treatment settings. The protocol is aimed at reducing neuropathic lower limb pain/discomfort.; Participants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not active.
Other intervention name(s): Moxa (abreviation); Moxa (abreviation)
Intervention MeSH terms: Lobeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuropathy, pain, neuropathic pain, diabetes, moxibustion