InsomniaNCT03503695
Auricular Acupuncture for Chronic Pain and Insomnia
A study testing Sterile acupuncture semi-permanent (ASP) gold needles in people with Insomnia and Chronic Pain, run by Landstuhl Regional Medical Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Chronic Pain
- What is being tested?
- Sterile acupuncture semi-permanent (ASP) gold needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auricular Acupuncture for Chronic Pain and Insomnia: a Randomized Clinical Trial
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.
Read more
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
- Being tested
- Sterile acupuncture semi-permanent (ASP) gold needles
- Keywords
- auricular acupuncture, battlefield acupuncture, insomnia, chronic pain, randomized
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile acupuncture semi-permanent (ASP) gold needlesDevice
Also called Sedatelac
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, day 4, day 8
Secondary outcomes (4)
Change in Sleep Diary components over time
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.
Measured: Daily for duration of study
Change in Actigraphy measures over time
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.
Measured: Daily for duration of study
Change in Brief Pain Inventory over time
. 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)
Measured: Daily for duration of Study
Change in Defense and Veterans Pain Scale over time
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)
Measured: Daily for duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Nov 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landstuhl Regional Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ann Ketz, Landstuhl Regional Medical Center
- Investigators
- Ann K Ketz, PhD, Principal investigator, Landstuhl Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503695
- Sponsor's protocol ID
- M-10395
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture for Chronic Pain and Insomnia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03503695
- Acronym / sponsor ID
- M-10395
- Conditions
- Insomnia, Chronic Pain
- Keywords
- auricular acupuncture, battlefield acupuncture, insomnia, chronic pain, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Landstuhl Regional Medical CenterUS federal agency
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Active comparator | Device: Sterile acupuncture semi-permanent (ASP) gold needlesSterile 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. |
| Comparison Group | No intervention | –There will be no intervention. The participants will be instructed to return on Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile acupuncture semi-permanent (ASP) gold needlesAlso: Sedatelac | Device | Auricular Acupuncture |
Primary outcome
Change in Insomnia Severity Index over time
Time frame: 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)
4 secondary outcomes
Change in Sleep Diary components over time
Time frame: Daily for duration of study
Change in Actigraphy measures over time
Time frame: Daily for duration of study
Change in Brief Pain Inventory over time
Time frame: Daily for duration of Study
Change in Defense and Veterans Pain Scale over time
Time frame: Daily for duration of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann K Ketz, PhD principal investigator
Landstuhl Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile acupuncture semi-permanent (ASP) gold needles in people with Insomnia and Chronic Pain, run by Landstuhl Regional Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index over time (time frame: Baseline, day 4, day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.