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Auricular Acupuncture for Chronic Pain and Insomnia

NCT03503695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-04-06

No results posted yet for this study

Summary

Background: In the U.S. approximately 1.6 million adults use complementary and alternative or integrative medicine therapy for pain and insomnia. However, very few studies have tested the use of auricular acupuncture (AA) using a standard protocol for participants with chronic pain and insomnia.

Objective: To assess the feasibility and acceptability of AA and to evaluate the effectiveness of AA on pain severity score, pain interference score, and insomnia over an 8-day study period.

Subjects: 45 participants who met the eligibility criteria and signed the consent were randomized to either the AA group (AAG) or the usual care control group (CG) on day 4.

Intervention: A standard AA protocol using penetrating semi-permanent acupuncture needles and in-place for up to four days.

Main Outcome Measures: Brief Pain Inventory pain severity and interference scores for pain and Insomnia Severity Index (ISI) for insomnia.

Results: The use of the standard AA protocol in the AAG led to significant within- and between-group reduction in pain severity and interference scores when compared to the CG. Both groups showed within-group decrease in ISI. However, the AAG showed significant between-group reduction in ISI severity and from moderate to sub-threshold insomnia.

Conclusions: AA was found to show effectiveness in the treatment of chronic pain and insomnia. With a heightened focus on the opioid crisis in the U.S., this easy-to-administer protocol can be an option for treatment modality for military beneficiaries with chronic pain and insomnia.

Conditions

Interventions

DEVICE

Sterile acupuncture semi-permanent (ASP) gold needles

Sponsors & Collaborators

  • Landstuhl Regional Medical Center

    lead FED

Principal Investigators

  • Ann K Ketz, PhD · Landstuhl Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-01
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503695 on ClinicalTrials.gov