Clinical trial NCT03503695: Auricular Acupuncture for Chronic Pain and Insomnia
Official title: Auricular Acupuncture for Chronic Pain and Insomnia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Chronic Pain
Keywords: auricular acupuncture
battlefield acupuncture
insomnia
chronic pain
randomized
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
First posted: 2018-04-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Insomnia Severity Index over time
timeFrame: Baseline, day 4, day 8
Secondary outcomes:
measure: Change in Sleep Diary components over time
timeFrame: Daily for duration of study
measure: Change in Actigraphy measures over time
timeFrame: Daily for duration of study
measure: Change in Brief Pain Inventory over time
timeFrame: Daily for duration of Study
measure: Change in Defense and Veterans Pain Scale over time
timeFrame: Daily for duration of Study
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
state: APO Ae
Study officials:
affiliation: Landstuhl Regional Medical Center
name: Ann K Ketz, PhD
role: PRINCIPAL_INVESTIGATOR
References: