Clinical trial NCT05104047: Distal Peripheral Neuropathy in Type 2 Diabetes
Official title: Moxibustion for Neuropathic Pain in Type 2 DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Pain, Neuropathic
Diabetes
Keywords: neuropathy, pain, neuropathic pain, diabetes, moxibustion
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gracely Pain Scale
timeFrame: 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:
measure: Subjective Peripheral Neuropathy Screen (SPNS)
timeFrame: Change from baseline rating of neuropathy symptoms after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)
Other outcomes:
measure: Clinical Global Severity & Improvement Scale
timeFrame: Change from baseline rating of pain intensity after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)
measure: Neurological Sensory Testing (NST)
timeFrame: Change from baseline neurological physical assessment after 3 wks of twice-wkly treatment sessions
Locations:
city: New York
country: United States
facility: New York University, Division of Special Studies in Symptom Management
state: New York
city: New York
country: United States
facility: NYU Special Studies in Symptom Management
state: New York
Study officials:
affiliation: New York University
name: J. Anastasi, PhD
role: PRINCIPAL_INVESTIGATOR
References: