Acupuncture Relief for Chronic Neck Pain

Not Applicable

Withdrawn

• Conditions: Neck Pain, Posterior
• Interventions: Other: Acupuncture; Other: Usual Care

• Registration Number: NCT03859011
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2019-08-01
• Status Verified: 2022-05
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acupuncture	Usual Care	After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks), then no acupuncture between 10 weeks and 6 months. After treatment is completed, final measurement instruments are applied at 6 months. Questionnaires will be readministered at 2.5 and 6 months.
Acupuncture	Acupuncture	After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks), then no acupuncture between 10 weeks and 6 months. After treatment is completed, final measurement instruments are applied at 6 months. Questionnaires will be readministered at 2.5 and 6 months.
"Usual" care	Acupuncture	After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments) for 6 months. Questionnaires will be readministered at 2.5 and 6 months. After the control phase the participants will continue usual care (for example physical therapy, oral pain medication or ointments), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks, 8.5 months), then no acupuncture between 8.5 months and 12 months.
"Usual" care	Usual Care	After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments) for 6 months. Questionnaires will be readministered at 2.5 and 6 months. After the control phase the participants will continue usual care (for example physical therapy, oral pain medication or ointments), plus acupuncture 2X/week over 2 weeks, then once per week over 8 weeks (12 total treatments over 10 weeks, 8.5 months), then no acupuncture between 8.5 months and 12 months.

Primary Outcome Measures

Name	Time	Method
Change in the Neck Disability Index (NDI)	Baseline though 8 months	The NDI will be used to measure pain and functional disability in the neck, and is the most widely used questionnaire to evaluate cervical pain and dysfunction in daily life. It consists of 10 questions, with a 6-point Likert scale from 0 to 5 points. The overall score ranges from 0 to 50 points, and a higher score indicates a greater degree of perceived functional disability.

Secondary Outcome Measures

Name	Time	Method
Change in Acupuncture Expectancy Scale	Baseline though 8 months	This four-question assessment uses a 5-point Likert scale with 1=not at all and 5= Completely. The higher score indicates a higher expectation that acupuncture will be helpful.
Change in PROMIS® Scale v1.2. PROMIS® (Patient-Reported Outcomes Measurement Information System)	Baseline though 8 months	Patient questionnaire be used to evaluate and monitor physical, mental and social health. The ten-question assessment uses a 5-point Likert scale with 5=never and 1= always. The higher score indicates better health.
Change in the Numeric Pain Rating Scale (NRS)	Baseline though 8 months	Participants will be instructed to report the intensity of neck pain experienced within the past week on a linear scale of 0 to 10 (0, no pain; 10, pain as bad as it could be).
Change in EuroQol 5-Dimension (EQ-5D-5L) Questionnaire	Baseline though 8 months	The EQ-5D-5L consists of five categories (mobility, personal care, daily activities, pain/discomfort and anxiety/depression), and each category contains five statements describing personal health status10. Each dimension can be score on one of five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Participants will be instructed to select the most appropriate one among the five statements. The responses represent a health state, which then be converted into a utility score between 0 and 1, where 0 represents death and 1 represents perfect health.
Change in Cost Effectiveness	Baseline though 8 months	Patient questionnaire to be used to evaluate the direct non health care costs of therapy

Trial Locations

Locations (2)

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

UF Jax ASCENT; 🇺🇸 Jacksonville, Florida, United States