Distal Peripheral Neuropathy in Type 2 Diabetes

NCT05104047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-08-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Moxibustion - Traditional (Active)

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.

OTHER

Moxibustion - Smokeless - (Active)

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.

OTHER

Placebo Moxibustion

Participants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not active.

Sponsors & Collaborators

  • New York University

    lead OTHER

Principal Investigators

  • J. Anastasi, PhD · New York University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2022-06-30
Completion
2022-08-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104047 on ClinicalTrials.gov