Acupuncture Relief for Chronic Neck Pain

NCT ID: NCT03859011

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2025-05-01

Brief 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. 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.

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.

Conditions

Neck Pain, Posterior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

After 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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

"Usual" care

After 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.

Group Type: PLACEBO_COMPARATOR

Acupuncture

Intervention Type: OTHER

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.

Interventions

Acupuncture

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

1. Have as their primary complaint radicular pain in the upper extremity with the distribution of a particular nerve root;

2. Report pain in another region that is more severe than the neck pain;

3. Have major hemorrhagic disease such as hemophilia;

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: collaborator

Utica College

OTHER

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: collaborator

5 Element Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Higgins, Captain MC USN ret., DO

Role: STUDY_CHAIR

Dept of Family Medicine, Naval Hospital Jacksonville

Locations

Naval Hospital Jacksonville

Jacksonville, Florida, United States

5 Element Institute

Jacksonville, Florida, United States

Countries

United States

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Other Identifiers

NHJX.2021.0099

Identifier Type: -

Identifier Source: org_study_id