Acupuncture Relief for Chronic Neck Pain

Completed · Not applicable

Conditions studied: Neck Pain, Posterior

In brief

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.

Key facts

Study ID

NCT03859011

Run by

5 Element Institute

People needed

75

Starts

2022-08-30

Expected to finish

2025-05-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• Naval Hospital Jacksonville — Jacksonville, Florida, United States
• 5 Element Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.