Distal Peripheral Neuropathy in Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Moxibustion for Neuropathic Pain in Type 2 DM

Conditions
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Peripheral Neuropathy, Pain, Neuropathic, Diabetes

Intervention / Treatment
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* Other: Moxibustion - Traditional (Active)
* Other: Moxibustion - Smokeless - (Active)
* Other: Placebo Moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 18-75 years of age, with a history of chronic bilateral neuropathic foot pain (pain, numbness, tingling) secondary to T2DM for the past three months or greater. Gracely Pain Scale (GPS) rated pain severity at moderate or above, documented in 1-week prospective self report symptom diary (SD)(a). Primary care provider (PCP) verification of T2DM diagnosis, report of neuropathic foot pain. Successfully complete a mini-mental status exam (obtaining a score of 24 or above). Must understand and agree to complete daily symptom diaries for the duration of the study. If on pharmacologic treatment(s) must have 21 days of stable regimen (same drugs, dose & frequency) prior to enrollment. Exclusion Criteria: Any acute condition requiring medical care (severe heart disease, uncontrolled hypertension, lung disease, renal failure, foot lesions, sores, ingrown nails, infection etc.). Use topically applied medications to the lower extremities / feet. Allergic to smoke Alcohol and/or substance dependence. Receiving injectable corticosteroids. Receiving other complementary therapies such as herbs, massage, acupuncture etc. for foot pain. Pregnant women. Relocation or other plans that interfere with attending all of the planned study session and/or recording SD information.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Moxibustion<br>Participants receive Active Traditional Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. | Other: Moxibustion - Traditional (Active)<br>* 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.<br>* Other names: Moxa (abreviation);|
| Active Comparator: Smokeless Moxibustion<br>Participants receive Active Smokeless Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. | Other: Moxibustion - Smokeless - (Active)<br>* 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.<br>* Other names: Moxa (abreviation);|
| Placebo Comparator: Placebo Moxibustion Control<br>Participants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not. Note. All participants randomized to the Control will be offered active protocol moxibustion treatments, at no cost, at the end of their study participation. | Other: Placebo Moxibustion<br>* Participants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not active.<br>|
| No Intervention: Waitlist Control<br>WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Moxibustion. Note. All participants randomized to the Control will be offered active protocol moxibustion treatments, at no cost, at the end of their study participation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gracely Pain Scale | The GPS is a Likert magnitude-estimation log-scale of sensory pain. Subjects rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. Nothing=0 to Extremely intense=12 | Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 3 wks of twice-wkly treatment sessions (the end of the treatment phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Peripheral Neuropathy Screen (SPNS) | Describes neuropathy symptoms eg. aching/burning, pins and needles, numbness, location (hands/arms, feet/legs), and severity of symptoms from minimal to extreme. | Change from baseline rating of neuropathy symptoms after 3 wks of twice-wkly treatment sessions (the end of the treatment phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, pain, neuropathic pain, diabetes, moxibustion