Acupuncture Relief for Chronic Neck Pain

• ClinicalTrials.gov Identifier: NCT03859011
• Recruitment Status: Withdrawn
• First Posted: March 1, 2019
• Last Update Posted: May 20, 2022
• Sponsor: University of Florida
• Collaborator: Utica College
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: February 27, 2019
• First Posted Date: March 1, 2019
• Last Update Posted Date: May 20, 2022
• Actual Study Start Date: August 1, 2019
• Actual Primary Completion Date: May 12, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2020)

Change in the Neck Disability Index (NDI) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: February 27, 2019)

Change in the Neck Disability Index (NDI) [ Time Frame: Baseline; Month 2.5; Month 3.5; Month 6 ]

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.

Current Secondary Outcome Measures (submitted: January 5, 2020)

• Change in the Numeric Pain Rating Scale (NRS) [ Time Frame: 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 [ Time Frame: 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 PROMIS® Scale v1.2. PROMIS® (Patient-Reported Outcomes Measurement Information System) [ Time Frame: 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 Acupuncture Expectancy Scale [ Time Frame: 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 Cost Effectiveness [ Time Frame: Baseline though 8 months ]
  Patient questionnaire to be used to evaluate the direct non health care costs of therapy

Original Secondary Outcome Measures (submitted: February 27, 2019)

• Change in the Numeric Pain Rating Scale (NRS) [ Time Frame: Baseline; Month 2.5; Month 3.5; Month 6 ]
  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 [ Time Frame: Baseline; Month 2.5; Month 6 ]
  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 PROMIS® Scale v1.2. PROMIS® (Patient-Reported Outcomes Measurement Information System) [ Time Frame: Baseline; Month 2.5; Month 6 ]
  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 Acupuncture Expectancy Scale [ Time Frame: Baseline; Month 2.5; Month 6 ]
  4-question patient questionnaire be used to evaluate a patients expectations of acupuncture.
• Change in Cost Effectiveness [ Time Frame: Baseline; Month 2.5; Month 6 ]
  Patient questionnaire be used to evaluate the direct non health care costs of therapy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acupuncture Relief for Chronic Neck Pain
• Official Title: Effectiveness and Cost-Effectiveness of Acupuncture for Chronic Neck Pain: A Pilot Randomized Controlled Trial
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Randomized Control Trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Neck Pain, Posterior

Intervention

• 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.

• Other: Usual Care
  Physical therapy, oral medications and topical ointments pre the discretion of the primary physician

Study Arms

• Experimental: 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.
  Interventions:

  • Other: Acupuncture
  • Other: Usual Care
• Placebo Comparator: "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.
  Interventions:

  • Other: Acupuncture
  • Other: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 16, 2022): 0
• Original Estimated Enrollment (submitted: February 27, 2019): 60
• Actual Study Completion Date: May 12, 2022
• Actual Primary Completion Date: May 12, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03859011
• Other Study ID Numbers: IRB201900266
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Florida
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Florida
• Original Study Sponsor: Same as current
• Collaborators: Utica College

Investigators

• Principal Investigator: Paul Mongan, MD; Professor, Department of Anesthesiology

• PRS Account: University of Florida
• Verification Date: May 2022