Auricular Acupuncture for Chronic Pain and Insomnia

Sponsor

Landstuhl Regional Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT03503695

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Chronic Pain	Device: Sterile acupuncture semi-permanent (ASP) gold needles	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Auricular Acupuncture for Chronic Pain and Insomnia: a Randomized Clinical Trial

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Sterile acupuncture semi-permanent (ASP) gold needles Other Names: Sedatelac
No Intervention: Comparison Group There will be no intervention. The participants will be instructed to return on Day 8.

Arm

Intervention/Treatment

Active Comparator: 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.

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

Other Names:

Sedatelac

No Intervention: Comparison Group

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

Outcome Measures

Primary Outcome Measures

Change in Insomnia Severity Index over time [Baseline, day 4, day 8]
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)

Secondary Outcome Measures

Change in Sleep Diary components over time [Daily for duration of study]
Sleep Diary 69. Collects and quantifies daily, subjective bedtime and waketime sleep parameters 70. A sleep diary in various formats is often used as a diagnostic tool for sleep disorders. In addition, due to one major weakness of validity check of real time completion, the sleep diary is often used in conjunction with actigraphy to establish validity in sleep parameters. Based on the recommendations for standard research assessment, a sleep diary should assess the following information: sleep onset latency (SOL), final waketime, number of awakenings (NWAK), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE), sleep quality (SQ), and time/duration of naps. Sleep diaries are standard practice and recommended for use in research studies of sleep disorder treatments.
Change in Actigraphy measures over time [Daily for duration of study]
Actigraphy is a watch-like device that documents sleep/wake patterns via movement over a period of time to estimate sleep parameters. It records in-time blocks (epochs) the participant's movement, light exposure, and other measures using accelerometry and a light meter. Various clinical research studies that have compared the outcomes among actigraphy vs. polysomnography (PSG) - the gold standard in sleep research. Correlation rates have been >90% in healthy adults and >84% in patients with sleep related breathing disorders when actigraphy has been compared to PSG 73,74. For Actiwatch 2, scoring software of Actiware will be used to determine sleep parameters of SOL, NWAK, WASO, TST, and SE.
Change in Brief Pain Inventory over time [Daily for duration of Study]
. Assesses four pain items and the degree of interference with seven aspects of functioning using a 0-10 Numeric Rating Scale. Four pain items include "pain now," "pain at its worst," "pain at its least," and "average" over the last 24 hours. The BPI also includes the location of pain on a body chart and the use of pain medications. "Worst pain" or the arithmetic mean of the 4 severity items can be used as measures of pain severity and the arithmetic mean of the 7 interference items can be used a as a measure of pain interference. Validity and reliability are high in various chronic pain populations (.77-.91)
Change in Defense and Veterans Pain Scale over time [Daily for duration of Study]
This 5-item scale was developed by a 22-member Pain Management Task Force as a standard pain assessment in the Department of Defense (DoD)/Veterans Administration (VA) system for continuity of care of service members. However, there are very few studies on its validity and reliability. The scale integrates a currently used numeric pain rating scale with visual facial cues and word descriptors. In addition there are 4 supplemental questions on pain interference modified from the BPI. Construct validity using component factor analysis revealed one item group (factor loadings >.78 and >.81) for outpatient and inpatient participants, respectively, with high internal consistency (.87-.90)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.