Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy, Neurology, Neurology, Neurology, Neurology, Neurology, Neurology |
| Therapuetic Areas: | Endocrinology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2017 |
| Start Date: | March 2015 |
| End Date: | March 2016 |
Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy
Peripheral neuropathy is a common complication of diabetes, and one of the strongest
determinants of reduced health-related quality of life among people with diabetes.
Neuropathy frequently presents with painful symptoms, activity limitation, insomnia,
fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at
least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN),
but often decrease other domains of quality of life through adverse effects, such as dry
mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical
approaches for PDN are needed, particularly for low income and racial/ethnic minorities who
are at highest risk of diabetes and related complications. Acupuncture is a promising
treatment for PDN, but evidence is limited. To address the significant public health need
related to pain management among underserved people with diabetes, this study proposes an
innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty
patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care
combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12
weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims
of the study are to determine the feasibility of group acupuncture for PDN among underserved
patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture
on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve
conduction velocity, and protective sensation; and to determine the optimal frequency of
acupuncture treatments.
The investigators hypothesize that compared to patients receiving usual care alone, patients
who undergo weekly group acupuncture treatments will have:
1. decreased pain intensity
2. improved health-related quality of life
3. improved sural nerve conduction velocity
determinants of reduced health-related quality of life among people with diabetes.
Neuropathy frequently presents with painful symptoms, activity limitation, insomnia,
fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at
least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN),
but often decrease other domains of quality of life through adverse effects, such as dry
mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical
approaches for PDN are needed, particularly for low income and racial/ethnic minorities who
are at highest risk of diabetes and related complications. Acupuncture is a promising
treatment for PDN, but evidence is limited. To address the significant public health need
related to pain management among underserved people with diabetes, this study proposes an
innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty
patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care
combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12
weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims
of the study are to determine the feasibility of group acupuncture for PDN among underserved
patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture
on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve
conduction velocity, and protective sensation; and to determine the optimal frequency of
acupuncture treatments.
The investigators hypothesize that compared to patients receiving usual care alone, patients
who undergo weekly group acupuncture treatments will have:
1. decreased pain intensity
2. improved health-related quality of life
3. improved sural nerve conduction velocity
Inclusion Criteria:
- English, Spanish, or Cantonese speaking
- Diagnosed with type 2 diabetes mellitus
- Distal lower limb pain present for at least three months
- A score of 4 or greater on the 11-point Pain Intensity Numerical Rating Scale
(PI-NRS) for the pain of diabetic peripheral neuropathy at least four days a week
before randomization
- Pain characterized as burning, shooting, or stabbing in nature
- Ability to understand study procedures and willingness to comply with them for the
entire length of the study
- A score of less than 8 on the Semmes-Weinstein monofilament test
- Stable use of pain control medications for PDN in the one month prior to screening
(e.g. no change in prescription) or no use of pain control medications for PDN within
the past one month
Exclusion Criteria:
- Substance abuse (as assessed by the Simple Screening Instrument for Substance Abuse)
- Unstable medical condition (e.g. severe pulmonary disease, myocardial infarction,
severe depressive symptoms)
- Electrical therapy (e.g. TENS unit) or patch treatment (e.g. lidocaine or capsaicin)
for PDN used within the past two weeks
- Acupuncture, moxibustion, cupping or herbal medicine for PDN used within the past two
weeks
- Pregnancy, planning a pregnancy or breast-feeding
- Inability or unwillingness to comply with this study protocol, assessed prior to
randomization
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San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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