Auricular Acupuncture for Chronic Pain and Insomnia

NCT ID: NCT03503695

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2017-10-31

Brief 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

Insomnia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Auricular Acupuncture

Sterile acupuncture semi-permanent (ASP) gold needles will be administered in the following acupuncture points: Cingulate Gyrus, Thalamus point, Omega 2, Point Zero, and Shen Men starting in either ear and alternating left and right until 10 ASP needles are placed. The needles may remain in the AA points for 3-4 days.

Group Type: ACTIVE_COMPARATOR

Sterile acupuncture semi-permanent (ASP) gold needles

Intervention Type: DEVICE

Comparison Group

There will be no intervention. The participants will be instructed to return on Day 8.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sterile acupuncture semi-permanent (ASP) gold needles

Intervention Type: DEVICE

Other Intervention Names

Sedatelac

Eligibility Criteria

Inclusion Criteria

• military beneficiary - active duty, retiree, or dependents
• between the ages of 18 - 65 years
• fall under the care of LRMC footprint
• self-report of insomnia based on established research criteria
• sleep-onset latency (SOL) or wakefulness after sleep onset of ≥30 minutes;

• frequency of at least three times a week;
• duration of ≥3 months;
• with unrestorative or unrefreshing sleep
• NRS Pain rating ≥3 (mild to severe level)
• pain for ≥3 months
• able to read and understand English
• for active duty military, an agreement of supervisor

Exclusion Criteria

• hypersensitivity or allergy to gold.
• pregnancy or plan for future pregnancy during the duration of the study (since the safety of AA in pregnant women has not been established; based on self-report rather than requiring a pregnancy test)
• ear trauma or unhealed wounds on the ear
• participation in any other research protocol with a device or drugs
• piercing or scar tissue in any of the AA point areas
• working in jobs with variable hours (e.g., shift work)
• acupuncture treatment within the last 3 months
• individuals with valvular prosthetics, hemophilia, or currently receiving an anticoagulant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landstuhl Regional Medical Center

FED

Sponsor Role: lead

Responsible Party

Ann Ketz

Chief, Center for Nursing Science & Clinical Inquiry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann K Ketz, PhD

Role: PRINCIPAL_INVESTIGATOR

Landstuhl Regional Medical Center

Locations

Landstuhl Regional Medical Center

Landstuhl, APO AE, Germany

Countries

Germany

Other Identifiers

M-10395

Identifier Type: -

Identifier Source: org_study_id