Distal Peripheral Neuropathy in Type 2 Diabetes

NCT ID: NCT05104047

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2022-08-30

Brief 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.

Conditions

Peripheral Neuropathy; Pain, Neuropathic; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Traditional Moxibustion

Participants receive Active Traditional Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort.

Group Type: ACTIVE_COMPARATOR

Moxibustion - Traditional (Active)

Intervention Type: OTHER

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

Participants receive Active Smokeless Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort.

Group Type: ACTIVE_COMPARATOR

Moxibustion - Smokeless - (Active)

Intervention Type: OTHER

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.

Placebo Moxibustion Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo Moxibustion

Intervention Type: OTHER

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

Waitlist Control

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 Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Placebo Moxibustion

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

Intervention Type: OTHER

Other Intervention Names

Moxa (abreviation); Moxa (abreviation)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Anastasi, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

New York University, Division of Special Studies in Symptom Management

New York, New York, United States

NYU Special Studies in Symptom Management

New York, New York, United States

Countries

United States

Other Identifiers

S17-00829

Identifier Type: -

Identifier Source: org_study_id