Clinical trial NCT03859011: Acupuncture Relief for Chronic Neck Pain
Official title: Effectiveness and Cost-Effectiveness of Acupuncture for Chronic Neck Pain: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neck Pain, Posterior
Keywords: acupuncture
pain
disability
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Utica College
First posted: 2019-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This study will measure 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 measure 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, 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.

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.
* Pain will be more than 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:

* Have as their primary complaint radicular pain in the upper extremity with the distribution of a particular nerve root that is greater than the chronic neck pain.
* Have one of the following cervical 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 cervical 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 cervical spinal surgery or be pre-scheduled for such surgery prior to enrollment in 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.
* 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 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.

Primary outcomes:
measure: Change in the Neck Disability Index (NDI)
timeFrame: Baseline though 8 months
Secondary outcomes:
measure: Change in the Numeric Pain Rating Scale (NRS)
timeFrame: Baseline though 8 months
measure: Change in EuroQol 5-Dimension (EQ-5D-5L) Questionnaire
timeFrame: Baseline though 8 months
measure: Change in PROMIS® Scale v1.2. PROMIS® (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline though 8 months
measure: Change in Acupuncture Expectancy Scale
timeFrame: Baseline though 8 months
measure: Change in Cost Effectiveness
timeFrame: Baseline though 8 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: UF Jax ASCENT
state: Florida
Study officials:
affiliation: Professor, Department of Anesthesiology
name: Paul Mongan, MD
role: PRINCIPAL_INVESTIGATOR
References: