Acupuncture Relief for Chronic Neck Pain

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03859011
Study type	Interventional
Source	University of Florida
Contact
Status	Withdrawn
Phase	N/A
Start date	August 1, 2019
Completion date	May 12, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.