Acupuncture to Reduce Signs of Inflammation in Participants With Chronic Low Back Pain

NCT01376375 | Completed Phase 1

• 2 other identifiers: 11018811-AT-0188
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Researchers will look at blood samples for changes in different chemicals related to inflammation and pain. Objectives: \- To test the effect of acupuncture on blood chemicals associated with chronic low back pain. Eligibility:

• People at least 18 years of age who have chronic low back pain.
• Those who have had back surgery or had acupuncture for any medical condition may not participate. Design:
• This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.
• At the first study visit, participants will give a medical history and complete two questionnaires about their low back pain. They will also spend 30 minutes lying down on a bed, relaxing quietly.
• The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic the standard procedure, but no needles will be used. The standard procedure will be performed in the same location. A licensed, experienced acupuncturist will insert small disposable needles into acupuncture sites on the back, arms, and legs. Those in the study will not know whether they are receiving the sham or the standard acupuncture procedure.
• At some visits, participants will provide blood samples for testing. At every visit, participants will complete the questionnaires about low back pain.

Conditions

Pain

Keywords

Acupuncture; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP

Interventions

Acupuncture PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Participant must be greater than or equal to 18 years of age.
• Participant must understand and sign the protocol s informed consent document.
• Participant must have been diagnosed with chronic LBP between 3-12 months prior to enrollment.
• Participant must have LBP of greater than or equal to 3 points on a scale of 0 to 10 recorded on the BPI-SF at enrollment.
• Participant must have a RMDQ score of greater than or equal to 3.
• Participant must be able to comprehend English in order to complete questionnaires.

You may not qualify if:

• Participant is unable to comply with study procedures or follow-up visits.
• Participant is in another investigational study and actively receiving study therapy for LBP.
• Participant has received prior treatment with acupuncture for any medical conditions.
• Participant used analgesics, such as opiates or tramadol, within 30 days of enrollment.
• Participant has a significant medical or psychiatric condition that would preclude study completion as determined by the investigator.
• Participant has received corticosteroid treatment within 3 months of enrollment.
• Participant is receiving physical therapy, heat therapy, ultrasound, spinal manipulation, cognitive-behavioral therapy, biofeedback or anticonvulsants for his/her LBP.
• Participant has had back surgery.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Lewis K, Abdi S. Acupuncture for lower back pain: a review. Clin J Pain. 2010 Jan;26(1):60-9. doi: 10.1097/AJP.0b013e3181bad71e.

  PMID: 20026956 BACKGROUND

• Ross JS. Non-mechanical inflammatory causes of back pain: Current concepts. Skeletal Radiol. 2006 Jul;35(7):485-7. doi: 10.1007/s00256-006-0121-5. No abstract available.

  PMID: 16752161 BACKGROUND

• Cuellar JM, Golish SR, Reuter MW, Cuellar VG, Angst MS, Carragee EJ, Yeomans DC, Scuderi GJ. Cytokine evaluation in individuals with low back pain using discographic lavage. Spine J. 2010 Mar;10(3):212-8. doi: 10.1016/j.spinee.2009.12.007.

  PMID: 20207331 BACKGROUND

MeSH Terms

Conditions

Pain; Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lai Wei, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 20, 2011
• Study Start: June 10, 2011
• Primary Completion: April 26, 2013
• Study Completion: April 26, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-04-26

Locations

US (1)