Distal Peripheral Neuropathy in Type 2 Diabetes

NCT05104047 | Completed

• 1 other identifier: S17-00829
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Neuropathy; Pain, Neuropathic; Diabetes

Keywords

neuropathy, pain, neuropathic pain, diabetes, moxibustion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective Peripheral Neuropathy Screen (SPNS)

  Change from baseline rating of neuropathy symptoms after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)

Other Outcomes (2)

• Clinical Global Severity & Improvement Scale

  Change from baseline rating of pain intensity after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)

• Neurological Sensory Testing (NST)

  Change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions

Study Arms (4)

Traditional Moxibustion

ACTIVE COMPARATOR

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

Other: Moxibustion - Traditional (Active)

Smokeless Moxibustion

ACTIVE COMPARATOR

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

Other: Moxibustion - Smokeless - (Active)

Placebo Moxibustion Control

PLACEBO COMPARATOR

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

Waitlist Control

NO 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.

Interventions

Moxibustion - Traditional (Active) 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.

Also known as: Moxa (abreviation)

Traditional Moxibustion

Moxibustion - Smokeless - (Active) 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.

Also known as: Moxa (abreviation)

Smokeless Moxibustion

Placebo Moxibustion OTHER

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

Placebo Moxibustion Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead

Study Sites (2)

New York University, Division of Special Studies in Symptom Management

New York, New York, 10010, United States

Location

NYU Special Studies in Symptom Management

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia; Diabetes Mellitus; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• J. Anastasi, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: November 2, 2021
• Study Start: July 29, 2019
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)