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A Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Award Number: R01NR017917
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/27/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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A Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain - 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. Our studies, using acupuncture and moxibustion (Acu/Moxa) to manage HIV DSP pain, show promise as an effective therapy. This study builds on preliminary data to test a novel approach, Acu/Moxa, to manage chronic lower-limb DSP pain in adults living with HIV. IMPACT: there are no FDA-approved agents for this indication in HIV. Effective management of DSP pain is an unmet therapeutic need for this population. Results from this study can provide patients and clinicians with an evidenced-based non-pharmacologic therapeutic option to manage this painful condition. The literature, our clinical experience, our preliminary studies and strength of our team provide a strong rationale to conduct a rigorous, randomized, blinded, placebo-controlled clinical trial of the efficacy of Acu/Moxa for HIV DSP pain that adheres to the CONSORT and STRICTA guidelines. 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. The primary intent-to-treat analysis of group differences in within-subject longitudinal change from baseline to Tx and F/U uses linear mixed models for repeated measures (LMMrm) with fixed effects for DA, treatment group, time, their interactions with covariate adjustment for the level of the outcome at baseline (SA#1 & SA#2). Preliminary studies estimate of “medium” effect sizes for the Gracely Pain Scale and 20% attrition indicates the need for 196 subjects to achieve 80% power and 5% alpha to detect the superiority of one active treatment to control, and one active treatment to the other. Cross-sectional and longitudinal associations between TCM diagnoses, NST assessments and pain medication use with change in patient-rated effectiveness will use multiple correlation/regression for aim #4.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$95,987 )
2025	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S FL 11	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	5	9/9/2025	NON-COMPETING CONTINUATION	-$95,987
														Subtotal = -$95,987

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	001	5	3/27/2024	NON-COMPETING CONTINUATION	$0
2024	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	5	11/8/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	5	12/2/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $664,730 )
2022	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	002	5	6/30/2022	NON-COMPETING CONTINUATION	$664,730
2022	2021	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	4	3/31/2022	NON-COMPETING CONTINUATION	$0
2022	2021	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	001	4	6/30/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $664,730

Issue Date FY: 2021 ( Subtotal = $703,930 )
2021	2021	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	4	5/14/2021	NON-COMPETING CONTINUATION	$703,930
														Subtotal = $703,930

Issue Date FY: 2020 ( Subtotal = $703,930 )
2020	2020	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	3	4/30/2020	NON-COMPETING CONTINUATION	$703,930
														Subtotal = $703,930

Issue Date FY: 2019 ( Subtotal = $703,930 )
2019	2019	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	2	5/29/2019	NON-COMPETING CONTINUATION	$703,930
														Subtotal = $703,930

Issue Date FY: 2018 ( Subtotal = $699,413 )
2018	2018	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Nursing Research	000	1	8/27/2018	NEW	$699,413
														Subtotal = $699,413

Grand Total All Awards = $3,379,946

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A Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Award Number: R01NR017917

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/27/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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