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Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855111
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Joyce K. Anastasi, New York University

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain HIV Neuropathy HIV/AIDS Pain Other: Standard Acupuncture / Moxibustion Other: Individualized (Tailored) Active Acupuncture / Moxibustion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, blinded, placebo-controlled clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Gracely Pain Scale (GPS) [ 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). ]

    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 :
  1. Subjective Peripheral Neuropathy Screen (SPNS) [ 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) ]
    Describes neuropathy symptoms eg. aching/burning, "pins and needles", numbness, location (hands/arms, feet/legs), and severity of symptoms from "minimal" to "extreme".

  2. NIH PROMIS Pain Scale [ 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) ]
    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).

  3. Medical Outcome Survey - HIV (MOS-HIV) [ 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) ]
    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

  4. Clinical Global Severity Improvement Scale (CGIs) [ 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) ]
    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

  5. Neurological Sensory Testing (NST) [ 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855111


Contacts
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Contact: Joyce K Anastasi, PhD 212-992-7044 joyce.anastasi@nyu.edu

Locations
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United States, New York
New York University, Division of Special Studies in Symptom Management Recruiting
New York, New York, United States, 10010
Contact: Paula Garcia, MS    212-992-5959    paula.garcia@nyu.edu   
Principal Investigator: Joyce K Anastasi, PhD         
Sponsors and Collaborators
New York University
National Institutes of Health (NIH)
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Responsible Party: Joyce K. Anastasi, Independence Foundation Professor; Director, Division of Special Studies in Symptom Management, New York University
ClinicalTrials.gov Identifier: NCT03855111    
Other Study ID Numbers: S18-00257
1R01NR017917-01 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After the outcome paper has been published
Access Criteria: Contact Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joyce K. Anastasi, New York University:
Neuropathic pain
HIV Neuropathy
HIV/AIDS
Symptom Management
Acupuncture
Pain
Pain Syndrome
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases