Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Pain Clinical Trial

Official title:

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855111
• Other study ID #: S18-00257
• Secondary ID: NIH-1R01NR017917
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2021
• Source: New York University
• Contact: Joyce K Anastasi, PhD
• Phone: 212-992-7044
• Email: joyce.anastasi[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Neuropathy
• HIV/AIDS
• Neuralgia
• Neuropathic Pain
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	New York University, Division of Special Studies in Symptom Management	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)