Traditional Moxibustion for Peripheral Neuropathy (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

Peripheral Neuropathy
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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions for reporting.

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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