Acupuncture Relief for Chronic Neck Pain

NCT03859011 | Completed

• 1 other identifier: NHJX.2021.0099
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain, Posterior

Keywords

acupuncture; pain; neck pain

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (Short Form)

  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.

  Baseline though 8 months

Study Arms (2)

Acupuncture

EXPERIMENTAL

After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or neck injections), 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 4 months. After treatment is completed, final measurement instruments are applied at 4 months. Questionnaires will be readministered at 2.5 and 4 months.

Other: Acupuncture

"Usual" care

PLACEBO COMPARATOR

After obtaining baseline data and questionnaires, patients will receive usual care (for example physical therapy, oral pain medication or ointments) for 4 months. Questionnaires will be readministered at 2.5 and 4 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, 6.5 months), then no acupuncture between 6.5 months and 8 months. Questionnaires will be readministered at 6.5 and 8 months.

Other: Acupuncture

Interventions

Acupuncture OTHER

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.

"Usual" care; Acupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have as their primary complaint radicular pain in the upper extremity with the distribution of a particular nerve root;
• Report pain in another region that is more severe than the neck pain;
• Have major hemorrhagic disease such as hemophilia;
• Report a history of hypersensitive reaction to previous acupuncture treatment, metal allergy, or major skin hypersensitivities;

Sponsors & Collaborators

• 5 Element Institute: lead
• United States Naval Medical Center, Portsmouth: collaborator
• Utica College: collaborator
• RAND: collaborator

Study Sites (2)

Naval Hospital Jacksonville

Jacksonville, Florida, 32214, United States

Location

5 Element Institute

Jacksonville, Florida, 32216, United States

Location

Related Publications (17)

• https://www.jointcommission.org/en-us/standards/national-performance-goals/pain-management

  BACKGROUND

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  PMID: 29211741 BACKGROUND

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  PMID: 11431299 BACKGROUND

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• MacPherson H, Tilbrook H, Richmond S, Woodman J, Ballard K, Atkin K, Bland M, Eldred J, Essex H, Hewitt C, Hopton A, Keding A, Lansdown H, Parrott S, Torgerson D, Wenham A, Watt I. Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial. Ann Intern Med. 2015 Nov 3;163(9):653-62. doi: 10.7326/M15-0667.

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  BACKGROUND

MeSH Terms

Conditions

Neck Pain; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• James Higgins, Captain MC USN ret., DO

  Dept of Family Medicine, Naval Hospital Jacksonville

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: August 30, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)