NCT03859011

Acupuncture Relief for Chronic Neck Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: 5 Element Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2019-03-01
• Last updated: 2026-01-20

Locations

2 sites across 1 country: United States