Trials / Completed
CompletedNCT03503695
Auricular Acupuncture for Chronic Pain and Insomnia
Auricular Acupuncture for Chronic Pain and Insomnia: a Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Landstuhl Regional Medical Center · Federal
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Sterile acupuncture semi-permanent (ASP) gold needles |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2018-04-20
- Last updated
- 2022-04-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03503695. Inclusion in this directory is not an endorsement.