Auricular Acupuncture for Chronic Pain and Insomnia

NCT03503695 | Completed

• 1 other identifier: M-10395
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Keywords

auricular acupuncture; battlefield acupuncture; insomnia; chronic pain; randomized

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index over time

  Insomnia Severity Index (ISI). Assesses the perceived severity and impact of insomnia symptoms based on a 5-point Likert with a total score from 0-28 with \>14 indicating moderate to severe insomnia. The sensitivity and specificity are 94% using a cutoff score of 14. Good test-retest (.78), face validity as defined by DSM-IV, and concurrent validity (.32 - .99)

  Baseline, day 4, day 8

Secondary Outcomes (4)

• Change in Sleep Diary components over time

  Daily for duration of study

• Change in Actigraphy measures over time

  Daily for duration of study

• Change in Brief Pain Inventory over time

  Daily for duration of Study

• Change in Defense and Veterans Pain Scale over time

  Daily for duration of Study

Study Arms (2)

Auricular Acupuncture

ACTIVE COMPARATOR

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.

Device: Sterile acupuncture semi-permanent (ASP) gold needles

Comparison Group

NO INTERVENTION

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

Interventions

Sterile acupuncture semi-permanent (ASP) gold needles DEVICE

Also known as: Sedatelac

Auricular Acupuncture

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Landstuhl Regional Medical Center: lead

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, APO AE, 09180, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann K Ketz, PhD

  Landstuhl Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Center for Nursing Science & Clinical Inquiry

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 20, 2018
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

DE (1)