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 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.

Study Overview

• Status: Recruiting
• Conditions: Pain; HIV/AIDS; Neuropathic Pain; HIV Neuropathy
• Intervention / Treatment: Other: Standard Acupuncture / Moxibustion; Other: Individualized (Tailored) Active Acupuncture / Moxibustion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joyce K Anastasi, PhD; Phone Number: 212-992-7044; Email: joyce.anastasi@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • New York University, Division of Special Studies in Symptom Management
      • Contact: Ellie Gonzalez; Phone Number: 212-992-5959; Email: eg3400@nyu.edu
      • Principal Investigator: Joyce K Anastasi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard (fixed) protocol Acu/Moxa - Active; Standard (Fixed) Acupuncture / Moxibustion Active Protocol Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.	Other: Standard Acupuncture / Moxibustion; Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.; Other Names: Standard Acupuncture /Moxibustion
Experimental: Individualized (tailored) protocol Acu/Moxa - Active; Individualized (Tailored) Active Acupuncture / Moxibustion Protocol Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.	Other: Individualized (Tailored) Active Acupuncture / Moxibustion; Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.; Other Names: Individualized Active Acupuncture / Moxibustion
No Intervention: Sham Acu/Placebo Moxa (Control); 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.
No Intervention: WaitList (Control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Measures

Outcome Measure	Measure Description	Time Frame
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".	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)
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).	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)
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	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)
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	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)
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.	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)

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Acupuncture; Neuropathic pain; HIV/AIDS; Symptom Management; HIV Neuropathy; Pain Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Slow Virus Diseases; HIV Infections; Neuralgia; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: S18-00257; NIH-1R01NR017917-01 (Other Grant/Funding Number: National Institutes of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No