Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)
NCT ID: NCT02104466
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-03-31
2016-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment as Usual (TAU)
Participants randomized to this arm will receive usual care with no acupuncture.
No interventions assigned to this group
TAU + 12 wks of acupuncture 1x/week
Participants randomized to this arm will receive usual care with adjunctive acupuncture once per week for a period of 12 weeks.
Acupuncture
Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
TAU + 12 wks of acupuncture 2x/week
Participants randomized to this arm will receive usual care with adjunctive acupuncture twice per week for a period of 12 weeks.
Acupuncture
Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
Interventions
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Acupuncture
Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Maria T Chao, DrPH, MPA
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco General Hospital
San Francisco, California, United States
Countries
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References
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Solli O, Stavem K, Kristiansen IS. Health-related quality of life in diabetes: The associations of complications with EQ-5D scores. Health Qual Life Outcomes. 2010 Feb 4;8:18. doi: 10.1186/1477-7525-8-18.
Van Acker K, Bouhassira D, De Bacquer D, Weiss S, Matthys K, Raemen H, Mathieu C, Colin IM. Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes Metab. 2009 Jun;35(3):206-13. doi: 10.1016/j.diabet.2008.11.004. Epub 2009 Mar 17.
Jensen MP, Chodroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology. 2007 Apr 10;68(15):1178-82. doi: 10.1212/01.wnl.0000259085.61898.9e.
Vinik A. CLINICAL REVIEW: Use of antiepileptic drugs in the treatment of chronic painful diabetic neuropathy. J Clin Endocrinol Metab. 2005 Aug;90(8):4936-45. doi: 10.1210/jc.2004-2376. Epub 2005 May 17.
Wong MC, Chung JW, Wong TK. Effects of treatments for symptoms of painful diabetic neuropathy: systematic review. BMJ. 2007 Jul 14;335(7610):87. doi: 10.1136/bmj.39213.565972.AE. Epub 2007 Jun 11.
Wiffen P, Collins S, McQuay H, Carroll D, Jadad A, Moore A. Anticonvulsant drugs for acute and chronic pain. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001133. doi: 10.1002/14651858.CD001133.pub2.
Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005454. doi: 10.1002/14651858.CD005454.pub2.
Rutkove SB. A 52-year-old woman with disabling peripheral neuropathy: review of diabetic polyneuropathy. JAMA. 2009 Oct 7;302(13):1451-8. doi: 10.1001/jama.2009.1377. Epub 2009 Sep 8.
Adams AS, Zhang F, Mah C, Grant RW, Kleinman K, Meigs JB, Ross-Degnan D. Race differences in long-term diabetes management in an HMO. Diabetes Care. 2005 Dec;28(12):2844-9. doi: 10.2337/diacare.28.12.2844.
Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby JV. Ethnic disparities in diabetic complications in an insured population. JAMA. 2002 May 15;287(19):2519-27. doi: 10.1001/jama.287.19.2519.
Chao MT, Schillinger D, Nguyen U, Santana T, Liu R, Gregorich S, Hecht FM. A Randomized Clinical Trial of Group Acupuncture for Painful Diabetic Neuropathy Among Diverse Safety Net Patients. Pain Med. 2019 Nov 1;20(11):2292-2302. doi: 10.1093/pm/pnz117.
Other Identifiers
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14-12822
Identifier Type: -
Identifier Source: org_study_id
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