Neck Pain, Posterior
Conditions
Keywords
acupuncture, pain, neck pain
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.
Interventions
OTHERAcupuncture
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.
Sponsors
5 Element Institute
United States Naval Medical Center, Portsmouth
Utica College
RAND
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (Short Form) | Baseline though 8 months | The Brief Pain Inventory (Short Form) will be used to measure neck pain at the time intervals noted in the Arms and Interventions section above. This validated instrument will be used to compare the effectiveness of the intervention between the Intervention arm and the Control arm. This instrument measures pain on an 11-point scale, from 0 to 10. A higher number indicates a worse outcome, and a lower number indicates a better outcome. Feasibility of study design and implementation will be assessed. |
Countries
United States
Contacts
STUDY_CHAIRJames Higgins, Captain MC USN ret., DO
Dept of Family Medicine, Naval Hospital Jacksonville
Outcome results
None listed