Acupuncture Relief for Chronic Neck Pain

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,
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.

1. The primary aim of this trial is to explore the comparative effectiveness of acupuncture
plus "usual care" vs. usual care alone for reducing chronic neck pain.

2. The secondary aim of this trial is to evaluate the cost-effectiveness of acupuncture for
this condition from multiple perspectives.

The primary endpoint will be determined by comparing the mean change score on the neck
disability index from baseline (month 0) to the treatment completion (month 2.5), and 3.5
months after completion of the acupuncture treatment (month 6) between groups.

Inclusion Criteria:

- Have Grade II neck pain with no signs or symptoms of major structural pathology but
major interference with activities of daily living.18 Pain will be more than 4 out of
10 on the numeric pain rating scale (NRS) 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 (≤ 15 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:

- Have radicular pain in the upper extremity with the distribution of a particular nerve
root;

- Have one of the following neurological abnormalities:

1. paresthesia (sensory deficits),

2. positive sign on a special test: shoulder abduction relief sign test (Bakody
sign), Spurling test,

3. hyporeflexia of the deep tendon reflex,

4. pathological reflex: Hoffman sign, ankle clonus, Babinski sign, or

5. muscle atrophy;

- Have major spinal pathology such as neoplasm, spinal fractures, myelopathy,
spondylitis, systemic inflammatory diseases, other non-mechanical cause of neck pain
and congenital abnormality,

- Have a history of spinal surgery or be pre-scheduled for such surgery during the
study;

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

- Have a body mass index greater than 40;

- Report a history of hypersensitive reaction to previous acupuncture treatment, metal
allergy, keloid, severe atopy, open skin sores, and other skin hypersensitivities;

- Have hemorrhagic disease and/or factors that can affect hemostasis, such as
anti-coagulant or anti-platelet drug use;

- Have uncontrolled diabetes, or major cardiovascular disease;

- Have a history of neurotic or major psychiatric disability or cognitive instability;

- Have a current or recent (within the past 6 months) history of alcoholism, or or
current or recent history of drug abuse, including abusing opioids or other controlled
pain medication;

- Have a medical disorder that would contraindicate physical therapy;

- Have head or neck cancer, or neck pain associated with ongoing radiation treatment to
the head or neck;

- Be involved in known litigation related to neck pain;

- Report current use of dry needling trigger point therapy;

- Pregnancy;

- Report a recent history of prior acupuncture treatment within the past six months.