Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)

NCT02104466 | Completed DMC

• 2 other identifiers: 14-12822K01AT006545
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.decreased pain intensity
2. 2.improved health-related quality of life
3. 3.improved sural nerve conduction velocity

Conditions

Diabetic Peripheral Neuropathy

Keywords

acupuncture; pain; neuropathy

Outcome Measures

Primary Outcomes (2)

• Percentage of recruited participants retained for the 12-week intervention period

  12 weeks

• Change from baseline in average weekly pain on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at week 12

  Baseline, Weeks 1-12

Secondary Outcomes (8)

• Pain Qualities Assessment Scale

  Baseline, Weeks 1-12, Week 24

• Health-related quality of life

  Baseline, Week 6, Week 12, Week 18

• Depressive symptoms using the Patient Health Questionnaire

  Baseline, Week 6, Week 12, Week 18

• Participant rating of global improvement using the Patient Global Impression of Change scale

  Week 12

• Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile

  Baseline, Week 6, Week 12, Week 18

Other Outcomes (1)

• Use of medications at baseline and throughout 12-week intervention period

  Baseline, Week 12

Study Arms (3)

Treatment as Usual (TAU)

NO INTERVENTION

Participants randomized to this arm will receive usual care with no acupuncture.

TAU + 12 wks of acupuncture 1x/week

EXPERIMENTAL

Participants randomized to this arm will receive usual care with adjunctive acupuncture once per week for a period of 12 weeks.

Procedure: Acupuncture

TAU + 12 wks of acupuncture 2x/week

EXPERIMENTAL

Participants randomized to this arm will receive usual care with adjunctive acupuncture twice per week for a period of 12 weeks.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

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 1x/week; TAU + 12 wks of acupuncture 2x/week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (11)

• 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.

  PMID: 20132542 BACKGROUND

• 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.

  PMID: 19297223 BACKGROUND

• 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.

  PMID: 17420400 BACKGROUND

• 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.

  PMID: 15899953 BACKGROUND

• 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.

  PMID: 17562735 BACKGROUND

• 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.

  PMID: 16034857 BACKGROUND

• Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005454. doi: 10.1002/14651858.CD005454.pub2.

  PMID: 17943857 BACKGROUND

• 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.

  PMID: 19738078 BACKGROUND

• 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.

  PMID: 16306543 BACKGROUND

• 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.

  PMID: 12020332 BACKGROUND

• 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.

  PMID: 31127837 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Maria T Chao, DrPH, MPA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 4, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

US (1)