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Neck Pain, PosteriorNCT03859011

Acupuncture Relief for Chronic Neck Pain

A study testing Acupuncture in people with Neck Pain, Posterior, run by 5 Element Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the feasibility of measuring the effectiveness of "usual care" for chronic neck pain as defined in the protocol, compared with usual care plus acupuncture, for chronic neck pain. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Neck Pain, Posterior
What is being tested?
Acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
2 sitesUnited States
Study dates
30 Aug 2022to 1 May 2025
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have Grade II neck pain with no signs or symptoms of major structural pathology but major interference with activities of daily living.
  • Worst pain will be at least 4 out of 10 on the Brief Pain Inventory short form at the time of screening and a diagnosis of non-specific neck pain (axial and muscular neck pain, without radicular symptoms, is included) by a clinician based on history taking and physical examination, including any imaging examinations. Neck pain is defined as "pain, ache, or discomfort" in the area between the occiput and the third thoracic vertebra and between the medial borders of the scapulae.
  • Have persistent or recurrent neck pain lasting longer than 3 months, and occurring at least once per week
  • Have had at least one physician or emergency department visit for neck pain within the past 3 months AND be currently taking pain medication as prescribed, such as:
  • Acetaminophen
  • NSAIDS
Show all 10Show fewer
  • Narcotics (≤ 30 Oral Morphine Equivalents (OME)
  • Robaxin (or equivalent)
  • Be able to maintain a prone position for at least 20 minutes per the intervention methodology
  • Be able to provide written informed consent.

Who cannot join

  • Have as their primary complaint radicular pain in the upper extremity with the distribution of a particular nerve root;
  • Report pain in another region that is more severe than the neck pain;
  • Have major hemorrhagic disease such as hemophilia;
  • Report a history of hypersensitive reaction to previous acupuncture treatment, metal allergy, or major skin hypersensitivities;
  • 4. Have a history of cervical spine surgery, or be scheduled for cervical spine surgery, prior to enrollment in the study. However, subjects may be included if they have had a surgical consult but are not yet scheduled for surgery; 5. Be involved in known litigation related to neck pain; 6. Have head or neck cancer, or neck pain associated with ongoing radiation treatment to the head or neck; 7. Have a body mass index greater than 40; 8. Have a history of major psychiatric disability or cognitive instability; 9. Have a current or recent (within the past 6 months) history of alcoholism, or current or recent history of drug abuse, including abusing opioids or other controlled pain medication; 10. Have a known pregnancy; 11. Report a recent history of prior acupuncture treatment within the past three months. However, if the prior acupuncture treatment was for another region of the body and not systemic, such as auricular acupuncture, the exclusion period is within 6 weeks.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Naval Hospital Jacksonville

    Jacksonville, Florida, 32214

  • 5 Element Institute

    Jacksonville, Florida, 32216

Other trials in United States

About this study

Official title: Effectiveness and Cost-Effectiveness of Acupuncture for Chronic Neck Pain: A Pilot Randomized Controlled Trial

This study will assess the feasibility of measuring the effectiveness of "usual care" for chronic neck pain as defined in the protocol, compared with usual care plus acupuncture, for chronic neck pain. This study's hypothesis is that combining acupuncture with usual care will show a clinically relevant increase in the effectiveness of the integrated therapies, compared with usual care alone. This study will also assess the feasibility of measuring the cost-effectiveness of acupuncture for chronic neck pain. The hypothesis is that in economic evaluation terms, integrating acupuncture with usual care will not create significant overall costs, relative to the benefits which study patients obtain.

Read the detailed description

Low back and neck pain accounts for the third-highest amount of U.S. healthcare spending, estimated at $87.6 billion annually. Moderate quality evidence already exists showing acupuncture's effectiveness for low back pain. Other than a few mostly foreign randomized controlled trials (RCTs) on acupuncture for neck pain, there are fewer quality studies on acupuncture's effectiveness for neck pain than for low back pain. The safety of acupuncture is well established. The risk of hematoma or infection due to acupuncture is lower than with venipuncture.

There is a lack of evidence on the cost-effectiveness relationship of this treatment strategy in the United States. A PubMed search found only three cost-effectiveness analyses of acupuncture for neck pain studies, all done abroad.

Since Medicare and several large private insurance companies still do not cover acupuncture for chronic neck pain, patient access to this therapy is significantly limited by out-of-pocket cost. A quality comparative effectiveness and cost-effectiveness study on acupuncture for chronic neck pain is needed from several perspectives. From the patient perspective, such a study would inform patients and providers in decision-making regarding integrating acupuncture in the care plan. From a third-party payer perspective, such a study would inform insurance companies whether it is cost-effective for them to cover acupuncture for this specific diagnosis. From a societal perspective, such a study would inform policy decision-makers whether acupuncture is a sound "investment" to better make resource allocation decisions for its citizens.

Pharmacological treatment of chronic pain has had safety issues. The CDC reports that over the past 10 years the average number of US drug-related deaths has exceeded 80,000 lives. The vast majority of these deaths have resulted from abuse and misuse of opioid drugs. The opioid crisis has added weight and urgency to finding safe and effective non-pharmacological therapies to treat chronic pain, including chronic neck pain.

  1. The primary aim of this trial is to explore the feasibility of a large scale, multi-site comparative effectiveness trial of acupuncture plus "usual care" vs. usual care alone for reducing chronic neck pain.
  2. The secondary aim of this trial is to explore the feasibility of cost-effectiveness evaluation of acupuncture for this condition from multiple perspectives.

The primary endpoint will be determined by comparing the mean change score on the Brief Pain Inventory (Short Form) from baseline (month 0) to the treatment completion (month 2.5), and 1.5 months after completion of the acupuncture treatment (month 4) between groups.

Being tested
Acupuncture
Keywords
acupuncture, pain, neck pain
Medical subject headings
Neck Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    Patients will have DBC Spring Ten acupuncture needles (manufactured in China) manually inserted bilaterally on five standardized acupuncture points according to the treatment points of GB20, BL10, BL11, SI3, BL62 at 6-8 mm depth for 20 minutes each using a tonification technique to elicit a de qi response.

    After those needles are removed, the number of additional needles and additional acupuncture points used will be chosen at the acupuncturist's discretion.

Study groups in NCT03859011
Study groupRoleWhat they receive
AcupunctureExperimentalAfter obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or neck injections), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks), then no acupuncture between 10 weeks and 4 months. After treatment is completed, final measurement instruments are applied at 4 months. Questionnaires will be readministered at 2.5 and 4 months.
Receives: Other: Acupuncture
"Usual" carePlacebo comparatorAfter obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments) for 4 months. Questionnaires will be readministered at 2.5 and 4 months. After the control phase the participants will continue usual care (for example physical therapy, oral pain medication or ointments), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks, 6.5 months), then no acupuncture between 6.5 months and 8 months. Questionnaires will be readministered at 6.5 and 8 months.
Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brief Pain Inventory (Short Form)

    The Brief Pain Inventory (Short Form) will be used to measure neck pain at the time intervals noted in the Arms and Interventions section above. This validated instrument will be used to compare the effectiveness of the intervention between the Intervention arm and the Control arm.

    This instrument measures pain on an 11-point scale, from 0 to 10. A higher number indicates a worse outcome, and a lower number indicates a better outcome.

    Feasibility of study design and implementation will be assessed.

    Measured: Baseline though 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start30 Aug 2022
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

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
Crossover
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859011
Sponsor's protocol ID
NHJX.2021.0099
Status last verified
Jan 2026
First submitted
27 Feb 2019
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • https://www.jointcommission.org/en-us/standards/national-performance-goals/pain-management

  • Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008:1103.

    PubMed 19445809

  • van der Velde G, Yu H, Paulden M, Cote P, Varatharajan S, Shearer HM, Wong JJ, Randhawa K, Southerst D, Mior S, Sutton D, Jacobs C, Taylor-Vaisey A. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1582-1597. doi: 10.1016/j.spinee.2015.08.025. Epub 2015 Nov 26.

    PubMed 26631759

  • Willich SN, Reinhold T, Selim D, Jena S, Brinkhaus B, Witt CM. Cost-effectiveness of acupuncture treatment in patients with chronic neck pain. Pain. 2006 Nov;125(1-2):107-13. doi: 10.1016/j.pain.2006.06.006. Epub 2006 Jul 13.

    PubMed 16842918

  • Essex H, Parrott S, Atkin K, Ballard K, Bland M, Eldred J, Hewitt C, Hopton A, Keding A, Lansdown H, Richmond S, Tilbrook H, Torgerson D, Watt I, Wenham A, Woodman J, MacPherson H. An economic evaluation of Alexander Technique lessons or acupuncture sessions for patients with chronic neck pain: A randomized trial (ATLAS). PLoS One. 2017 Dec 6;12(12):e0178918. doi: 10.1371/journal.pone.0178918. eCollection 2017.

    PubMed 29211741

  • Vas J, Perea-Milla E, Mendez C, Sanchez Navarro C, Leon Rubio JM, Brioso M, Garcia Obrero I. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: a randomised controlled study. Pain. 2006 Dec 15;126(1-3):245-55. doi: 10.1016/j.pain.2006.07.002. Epub 2006 Aug 23.

    PubMed 16934402

  • Liang Z, Zhu X, Yang X, Fu W, Lu A. Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study. Complement Ther Med. 2011 Jan;19 Suppl 1:S26-32. doi: 10.1016/j.ctim.2010.11.005. Epub 2010 Dec 23.

    PubMed 21195292

  • Irnich D, Behrens N, Molzen H, Konig A, Gleditsch J, Krauss M, Natalis M, Senn E, Beyer A, Schops P. Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain. BMJ. 2001 Jun 30;322(7302):1574-8. doi: 10.1136/bmj.322.7302.1574.

    PubMed 11431299

  • Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.

    PubMed 24171895

  • Cameron ID, Wang E, Sindhusake D. A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash. Spine (Phila Pa 1976). 2011 Dec 15;36(26):E1659-65. doi: 10.1097/BRS.0b013e31821bf674.

    PubMed 21494196

  • Aranha MF, Muller CE, Gaviao MB. Pain intensity and cervical range of motion in women with myofascial pain treated with acupuncture and electroacupuncture: a double-blinded, randomized clinical trial. Braz J Phys Ther. 2015 Jan-Feb;19(1):34-43. doi: 10.1590/bjpt-rbf.2014.0066. Epub 2014 Nov 28.

    PubMed 25714602

  • Dieleman JL, Baral R, Birger M, Bui AL, Bulchis A, Chapin A, Hamavid H, Horst C, Johnson EK, Joseph J, Lavado R, Lomsadze L, Reynolds A, Squires E, Campbell M, DeCenso B, Dicker D, Flaxman AD, Gabert R, Highfill T, Naghavi M, Nightingale N, Templin T, Tobias MI, Vos T, Murray CJ. US Spending on Personal Health Care and Public Health, 1996-2013. JAMA. 2016 Dec 27;316(24):2627-2646. doi: 10.1001/jama.2016.16885.

    PubMed 28027366

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK458660/

    PubMed 29023083

  • MacPherson H, Tilbrook H, Richmond S, Woodman J, Ballard K, Atkin K, Bland M, Eldred J, Essex H, Hewitt C, Hopton A, Keding A, Lansdown H, Parrott S, Torgerson D, Wenham A, Watt I. Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial. Ann Intern Med. 2015 Nov 3;163(9):653-62. doi: 10.7326/M15-0667.

    PubMed 26524571

  • CDC National Center for Health Statistics Webpage: Provisional Drug Overdose Death Counts. 9/2025. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Neck Pain, Posterior, run by 5 Element Institute at 2 sites in United States.

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 10 inclusion and 5 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Brief Pain Inventory (Short Form) (time frame: Baseline though 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859011, which also lists 17 linked publications.

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 20 Jan 2026.

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