Safety of Acupuncture Treatments for Chronic Low Back Pain in Older Adults

NCT03850717 | Completed DMC FDA Device

• 1 other identifier: ATCMA 201901
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Acupuncture, along with other complementary and integrative treatments, is commonly used as a complementary or integrative therapy when treating a multitude of pain complaints, including chronic low back pain(CLBP). It has been practiced as a non-pharmacological therapy in the United States over one hundred years. Integrative pain management pilot programs have demonstrated impressive reductions in medications use, emergency room visits, and annual costs of healthcare. In fact, CLBP is one of the most common conditions treated in an acupuncturist's daily schedule. Based on acupuncturists' practice, CLBP has accounted for about 12% of patient visits in recent years. Most CLBP patients who come to acupuncturists' clinic are older adults. Investigators will retrospectively check the safety of acupuncture, i.e.side effects or adverse effects of acupuncture during treatments of CLBP in older adults in past 5 years.

Conditions

Chronic Low Back Pain; Older Adults

Outcome Measures

Primary Outcomes (1)

• The rate of participates with bleeding

  bruise in 3 levels: diameter\<5mm, 6-10mm, \>11mm

  2013-2018

Secondary Outcomes (4)

• The rate of participates with pain

  2013-2018

• The rate of participates with fainting

  2013-2018

• The rate of participates with organ injury

  2013-2018

• The rate of participates caused Infection

  2013-2018

Study Arms (2)

Traditional Chinese Acupuncture

Use traditional acupuncture, stronger, deeper, "harder-acupuncture"

Device: acupuncture

Japanese Acupuncture

Use traditional shallow, lighter acupuncture, "softer-acupuncture"

Device: acupuncture

Interventions

acupuncture DEVICE

insert in filiform needles into skin and other soft tissue to treat the illness or disorders

Japanese Acupuncture; Traditional Chinese Acupuncture

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* age: 65 years or older; * both genders; * white, black and other nationalities. * with chronic low back pain. * Had at least one acupuncture treatment in McLean Center for Complementary and Alternative Medicine, PLC during the period of Dec. 31, 2013 to Dec.30, 2018.

You may qualify if:

• Age: 65-80 years old.
• CLBP is defined as a back pain problem that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months.
• A minimum pain intensity score of 4 out of 10 on a visual analog scale (0 = no pain, 10 = most severe pain);
• ability of the participant to fully understand the trial procedure and the risks involved, communicate with the examiner, and comply with the protocol;
• provision of written informed consent for participation.

You may not qualify if:

• Age: younger than 65.
• Pain mainly at legs;
• a history of spinal surgery;
• hip osteoarthritis; progressive neurological deficit or severe psychiatric or psychological disorders;
• serious spinal disorders, such as metastatic cancer, vertebral fracture, spinal infection, and inflammatory spondylitis;
• other contraindications for treatment, such as clotting disorders, use of anticoagulants or chemotherapy medications, and seizure disorders;
• presence of a device that could be affected by electromagnetic fields, such as a pacemaker;
• use of medications that could affect the trial results, such as corticosteroids and anticonvulsants, within the last week;
• participation in other clinical trials;
• ineligibility judged by a researcher.

Sponsors & Collaborators

• McLean Center for Complementary and Alternative Medicine, PLC: lead

Study Sites (1)

McLean Center for Complementary and Alternative Medicine,PLC

Vienna, Virginia, 22182, United States

Location

Related Publications (2)

• Fan AY, Ouyang H, Qian X, Wei H, Wang DD, He D, Tian H, Gong C, Matecki A, Alemi SF. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. J Integr Med. 2019 Mar;17(2):71-76. doi: 10.1016/j.joim.2019.01.005. Epub 2019 Jan 26.

  PMID: 30738771 RESULT

• Chan MWC, Wu XY, Wu JCY, Wong SYS, Chung VCH. Safety of Acupuncture: Overview of Systematic Reviews. Sci Rep. 2017 Jun 13;7(1):3369. doi: 10.1038/s41598-017-03272-0.

  PMID: 28611366 RESULT

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Arthur Y Fan, MD, PhD, LAc

  McLean Center for Complementary and Alternative Medicine, PLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: December 31, 2013
• Primary Completion: December 30, 2018
• Study Completion: February 20, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)