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Traditional Moxibustion for Neuropathic Pain (DSP/DM Trial)
N/A
Waitlist Available
Led By J. Anastasi, PhD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions
Summary
This trial is testing moxibustion, a method that uses heat from burning herbs, to treat painful nerve damage in people with Type 2 diabetes. Current treatments for this condition are often ineffective. The heat from moxibustion may help by improving blood flow and reducing pain. Moxibustion is a traditional Chinese medicine therapy that involves burning dried mugwort on specific points on the body to improve blood circulation and has been used for various conditions including diabetic peripheral neuropathy.
Eligible Conditions
- Nerve Damage
- Diabetes
- Neuropathic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gracely Pain Scale
Secondary study objectives
Subjective Peripheral Neuropathy Screen (SPNS)
Other study objectives
Clinical Global Severity & Improvement Scale
Neurological Sensory Testing (NST)
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Traditional MoxibustionActive Control1 Intervention
Participants receive Active Traditional Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort.
Group II: Smokeless MoxibustionActive Control1 Intervention
Participants receive Active Smokeless Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort.
Group III: Waitlist ControlActive Control1 Intervention
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.
Group IV: Placebo Moxibustion ControlPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
New York UniversityLead Sponsor
241 Previous Clinical Trials
220,279 Total Patients Enrolled
1 Trials studying Neuropathic Pain
196 Patients Enrolled for Neuropathic Pain
J. Anastasi, PhDPrincipal InvestigatorNew York University