Peripheral NeuropathyDSP/DMNCT05104047
Distal Peripheral Neuropathy in Type 2 Diabetes
A study testing Moxibustion - Traditional (Active) and Moxibustion - Smokeless - (Active) in people with Peripheral Neuropathy and Pain, Neuropathic, run by New York University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy, Pain, Neuropathic, Diabetes
- What is being tested?
- Moxibustion - Traditional (Active) and Moxibustion - Smokeless - (Active)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University, Division of Special Studies in Symptom Management
New York, New York, 10010
NYU Special Studies in Symptom Management
New York, New York, 10010
About this study
Official title: Moxibustion for Neuropathic Pain in Type 2 DM
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.
Read the 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
- Being tested
- Moxibustion - Traditional (Active), Moxibustion - Smokeless - (Active), Placebo Moxibustion
- Keywords
- neuropathy, pain, neuropathic pain, diabetes, moxibustion
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxibustion - Traditional (Active)Other
Also called Moxa (abreviation)
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.
Moxibustion - Smokeless - (Active)Other
Also called Moxa (abreviation)
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 MoxibustionOther
Participants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not active.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Moxibustion | Active comparator | Participants receive Active Traditional Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. Receives: Other: Moxibustion - Traditional (Active) |
| Smokeless Moxibustion | Active comparator | Participants receive Active Smokeless Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Describes neuropathy symptoms eg. aching/burning, "pins and needles", numbness, location (hands/arms, feet/legs), and severity of symptoms from "minimal" to "extreme".
Measured: Change from baseline rating of neuropathy symptoms after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start29 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Anastasi, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104047
- Sponsor's protocol ID
- S17-00829
- Acronym
- DSP/DM
- Status last verified
- Aug 2023
- First submitted
- 16 Oct 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxibustion for Neuropathic Pain in Type 2 DM
- ClinicalTrials.gov ID
- NCT05104047
- Acronym / sponsor ID
- DSP/DM / S17-00829
- Conditions
- Peripheral Neuropathy, Pain, Neuropathic, Diabetes
- Keywords
- neuropathy, pain, neuropathic pain, diabetes, moxibustion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional Moxibustion | Active comparator | Other: Moxibustion - Traditional (Active)Participants receive Active Traditional Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. |
| Smokeless Moxibustion | Active comparator | Other: Moxibustion - Smokeless - (Active)Participants receive Active Smokeless Moxibustion - a protocol aimed at reducing neuropathic pain/discomfort. |
| Placebo Moxibustion Control | Placebo comparator | Other: Placebo MoxibustionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxibustion - Traditional (Active)Also: Moxa (abreviation)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 | Traditional Moxibustion |
| Moxibustion - Smokeless - (Active)Also: Moxa (abreviation)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 | Smokeless Moxibustion |
| Placebo MoxibustionParticipants receive Placebo Moxibustion - a protocol that mimics the active protocol but is not active. | Other | Placebo Moxibustion Control |
Primary outcome
Gracely Pain Scale
Time frame: Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)
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
1 secondary outcome
Subjective Peripheral Neuropathy Screen (SPNS)
Time frame: Change from baseline rating of neuropathy symptoms after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Peripheral Neuropathy
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Anastasi, PhD principal investigator
New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion - Traditional (Active) and Moxibustion - Smokeless - (Active) in people with Peripheral Neuropathy and Pain, Neuropathic, run by New York University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gracely Pain Scale (time frame: Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 3 wks of twice-wkly treatment sessions (the end of the treatment phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.