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Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Primary Purpose

Neuropathic Pain, HIV Neuropathy, HIV/AIDS

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Acupuncture / Moxibustion

Individualized (Tailored) Active Acupuncture / Moxibustion

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, HIV Neuropathy, HIV/AIDS, Symptom Management, Acupuncture, Pain, Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women, 18 years of age or older, HIV+ or AIDS diagnosed, with a history of DSP of the lower extremities for the past three months or greater.
Primary care provider (PCP) verification of HIV status, diagnosis of DSP, & subject clinical suitability for the study.
Evidence of lower limb neuropathy (bilateral ankle reflexes absent or depressed relative to the knee, decreased sensation to vibration, pin prick and temperature with distal sensory loss grading to normal in the proximal limb)
GPS rated pain severity of "moderate" or above, documented in 1-week prospective self-report symptom diary (SD).
Any antiretroviral Rx must have 3 months of stable regimen (same drugs, dose & frequency) prior to enrollment.
Any pain medications must have 3 months of stable regimen prior to enrollment.
Those on a stable pharmacologic regimen are expected to remain on the regimen for the duration of the study.
Must understand and agree to complete daily symptom diaries for the duration of the study.
Successfully complete a mini-mental status exam (obtaining a score of 24 or above).

Exclusion Criteria:

Any acute condition requiring medical care (eg. opportunistic infection).
Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc.
Use any topically applied medications to the lower extremities.
Alcohol and/or substance dependence.
Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment.
Pregnant women or unwilling to use an acceptable form of birth control.
Receiving acupuncture within 6 months prior to enrollment.
Any history of receiving moxibustion.
Currently receiving any other complementary therapies such as herbs, massage, reiki etc.
Relocation or plans that interfere with attending all of the planned study sessions and/or recording SD information.

Sites / Locations

New York University, Division of Special Studies in Symptom ManagementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Standard (fixed) protocol Acu/Moxa - Active

Individualized (tailored) protocol Acu/Moxa - Active

Sham Acu/Placebo Moxa (Control)

WaitList (Control)

Arm Description

Standard (Fixed) Acupuncture / Moxibustion Active Protocol Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.

Individualized (Tailored) Active Acupuncture / Moxibustion Protocol Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.

Sham Acu/Placebo Moxa (Control) Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.

WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion. Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.

Outcomes

Primary Outcome Measures

Gracely Pain Scale (GPS)

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

Secondary Outcome Measures

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".

NIH PROMIS Pain Scale

NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form is used to assess "how much a person hurts". Subjects in the last 7 days, the worst pain intensity, the average pain intensity. Subjects rate their pain intensity from none (=1) to very severe (=5).

Medical Outcome Survey - HIV (MOS-HIV)

General health-related quality of life questions in HIV that assesses ten dimensions of health (overall health, pain, physical functioning, role and social functioning, mental health, energy/fatigue, cognitive function, health distress

Clinical Global Severity Improvement Scale (CGIs)

The severity of illness scale measures global severity of symptoms [in the context of peripheral neuropathy]. The patient rates discomfort from peripheral neuropathy on a scale of 0= No discomfort to 6= Very severe discomfort. The global improvement component measures the level of change from initial severity: 0= No improvement at all to 6= Great improvement

Neurological Sensory Testing (NST)

Neurological assessments with Neuro Sensory Testing (NST) include: muscle strength and reflexes and sensory testing for lower limb vibration, pain and thermal sensation. Standard neurological assessment: muscle strength 0-5; reflexes 0-5; pain- intact, reduced, absent, hyperalgesia; vibration - intact, impaired; thermal - intact, reduced absent. The neuro/NST also serves to monitor for clinical safety and findings.

Full Information

NCT ID

NCT03855111

First Posted

February 20, 2019

Last Updated

October 26, 2021

Sponsor

New York University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03855111

Brief Title

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Official Title

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. In HIV there are no FDA-approved drugs for this indication. This study assesses in a randomized controlled clinical trial, the efficacy of novel non-pharmacologic pain management approaches to reduce HIV-related 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 20%-50% of persons living with HIV. 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 study is a randomized, blinded, placebo-controlled clinical trial of the efficacy of Acupuncture/Moxibustion (Acu/Moxa) for HIV DSP pain/discomfort. Subjects with HIV-related lower limb DSP pain are randomized to one of four Conditions: 1) Standard (fixed) protocol Acu/Moxa, 2) Individualized (tailored) protocol Acu/Moxa, 3) Sham Acu/Placebo Moxa (control), or 4) WaitList (control). Subjects attend six weeks of twice weekly treatment sessions and 3 non-treatment follow-up sessions at weeks 9, 11, and 15. All subjects are assessed by a blinded diagnostic acupuncturist (DA) and those assigned to Conditions 1, 2 and 3 receive treatments by an unblinded treating acupuncturist (TA). Specific Aims are: #1 determine group differences in weekly average pain (Gracely Pain Scale) at the end of treatment (Tx) and end of follow-up (F/U); SA#2 determine group differences in improvement in specific sensory symptoms (Subjective Peripheral Neuropathy Screen and neurological sensory testing (NST)) and patient-rated effectiveness (Clinical Global Improvement, NIH PROMIS Pain Intensity and Health-Related Quality of Life (MOS-HIV)) at Tx and F/U; SA#3 determine group differences in safety profiles; and SA#4, explore how baseline measures, TCM diagnoses, NST and pain medication use predict response to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, HIV Neuropathy, HIV/AIDS, Pain

Keywords

Neuropathic pain, HIV Neuropathy, HIV/AIDS, Symptom Management, Acupuncture, Pain, Pain Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, blinded, placebo-controlled clinical trial

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard (fixed) protocol Acu/Moxa - Active

Arm Type

Experimental

Arm Description

Standard (Fixed) Acupuncture / Moxibustion Active Protocol Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.

Arm Title

Individualized (tailored) protocol Acu/Moxa - Active

Arm Type

Experimental

Arm Description

Arm Title

Sham Acu/Placebo Moxa (Control)

Arm Type

No Intervention

Arm Description

Arm Title

WaitList (Control)

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Standard Acupuncture / Moxibustion

Other Intervention Name(s)

Standard Acupuncture /Moxibustion

Intervention Description

Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.

Intervention Type

Other

Intervention Name(s)

Individualized (Tailored) Active Acupuncture / Moxibustion

Other Intervention Name(s)

Individualized Active Acupuncture / Moxibustion

Intervention Description

Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.

Primary Outcome Measure Information:

Title

Gracely Pain Scale (GPS)

Description

Time Frame

Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine sustainability).

Secondary Outcome Measure Information:

Title

Subjective Peripheral Neuropathy Screen (SPNS)

Description

Describes neuropathy symptoms eg. aching/burning, "pins and needles", numbness, location (hands/arms, feet/legs), and severity of symptoms from "minimal" to "extreme".

Time Frame

Change from baseline rating of neuropathy symptoms after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

Title

NIH PROMIS Pain Scale

Description

Time Frame

Change from baseline rating of pain intensity after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

Title

Medical Outcome Survey - HIV (MOS-HIV)

Description

Time Frame

Change from baseline rating of general health after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

Title

Clinical Global Severity Improvement Scale (CGIs)

Description

Time Frame

Title

Neurological Sensory Testing (NST)

Description

Time Frame

Change from baseline neurological physical assessment after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women, 18 years of age or older, HIV+ or AIDS diagnosed, with a history of DSP of the lower extremities for the past three months or greater. Primary care provider (PCP) verification of HIV status, diagnosis of DSP, & subject clinical suitability for the study. Evidence of lower limb neuropathy (bilateral ankle reflexes absent or depressed relative to the knee, decreased sensation to vibration, pin prick and temperature with distal sensory loss grading to normal in the proximal limb) GPS rated pain severity of "moderate" or above, documented in 1-week prospective self-report symptom diary (SD). Any antiretroviral Rx must have 3 months of stable regimen (same drugs, dose & frequency) prior to enrollment. Any pain medications must have 3 months of stable regimen prior to enrollment. Those on a stable pharmacologic regimen are expected to remain on the regimen for the duration of the study. Must understand and agree to complete daily symptom diaries for the duration of the study. Successfully complete a mini-mental status exam (obtaining a score of 24 or above). Exclusion Criteria: Any acute condition requiring medical care (eg. opportunistic infection). Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc. Use any topically applied medications to the lower extremities. Alcohol and/or substance dependence. Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment. Pregnant women or unwilling to use an acceptable form of birth control. Receiving acupuncture within 6 months prior to enrollment. Any history of receiving moxibustion. Currently receiving any other complementary therapies such as herbs, massage, reiki etc. Relocation or plans that interfere with attending all of the planned study sessions and/or recording SD information.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joyce K Anastasi, PhD

Phone

212-992-7044

joyce.anastasi@nyu.edu

Facility Information:

Facility Name

New York University, Division of Special Studies in Symptom Management

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ellie Gonzalez

Phone

212-992-5959

eg3400@nyu.edu

First Name & Middle Initial & Last Name & Degree

Joyce K Anastasi, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Congruent with NIH policy, the PI will make any unique resources e.g. the protocol and materials developed for this research study be available for research purposes to qualified individuals within the scientific community through publication and presentations. In addition, research information will be made available upon request to Dr. Joyce K. Anastasi.

IPD Sharing Time Frame

After the outcome paper has been published

IPD Sharing Access Criteria

Contact Principal Investigator

Learn more about this trial

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

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