Status:
WITHDRAWN
Acupuncture Relief for Chronic Neck Pain
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Utica College
Conditions:
Neck Pain, Posterior
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 effectiven...
Eligibility Criteria
Inclusion
- 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
- 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:
- paresthesia (sensory deficits),
- positive sign on a special test: shoulder abduction relief sign test (Bakody sign), Spurling test,
- hyporeflexia of the deep tendon reflex,
- pathological reflex: Hoffman sign, ankle clonus, Babinski sign, or
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03859011
Start Date
August 1 2019
End Date
May 12 2022
Last Update
May 20 2022
Active Locations (2)
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1
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
2
UF Jax ASCENT
Jacksonville, Florida, United States, 32209