Research

Current NIH project

"Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adult":

https://clinicaltrials.gov/ct2/show/NCT04982315?term=NCT04982315&draw=2&rank=1

Brief Summary:

About 1/3 of older adults suffer from chronic low back pain, and there is a lack of evidence regarding the effectiveness of treatments for this population. This study is a two-arm pragmatic clinical trial that will compare acupuncture to usual medical care among older adults with chronic low back pain. We will also examine cost effectiveness of these treatments.

Detailed Description:

Low back pain (LBP) is the leading cause of years lived with disability worldwide. Among older adults, LBP is both prevalent and disabling. One-third of community-dwelling older adults in the US experience frequent back pain. Evidence for the safety and efficacy of pharmacologic treatment in older adults is limited, and guidelines now recommend non-pharmacologic treatments such as acupuncture, especially given the risks of long-term opioid use or invasive procedures in older patients. The American College of Physicians clinical practice guideline recommends acupuncture as first-line therapy for chronic LBP (Qaseem et al., 2017). In the only published trial of acupuncture exclusively enrolling older adults with chronic LBP, acupuncture was associated with clinically meaningful improvements in back-related disability compared to usual medical care (Sherman et al., 2017). A rigorous, pragmatic trial is needed to understand the effectiveness and cost-effectiveness of acupuncture for chronic LBP in older adults in real-world settings.

Objectives and Aims: In this multi-center, two-arm, pragmatic clinical trial, we propose to randomize 800 adults aged 65 years and older with chronic LBP to either 1) acupuncture or 2) usual medical care. The primary endpoint is back-related disability, measured by the Roland-Morris Disability Questionnaire (RDQ), at 6 months. We will also examine the cost-effectiveness of acupuncture versus usual care.

Eligibility

Ages Eligible for Study: 65 Years and older (Adult, Older Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Sampling Method: Non-Probability Sample

Study Population

Study Population: Inclusion criteria: Adults ≥65 years with chronic LBP, defined as back pain present on at least half the days in the past 6 months; ability to speak English; ability to attend study visits; and ability to provide informed consent. Exclusion criteria: (1) prior acupuncture treatment for LBP in the past year; (2) conditions that preclude safe acupuncture or completion of the study (e.g., severe cognitive impairment); (3) planned lumbar spine surgery within the next 6 months; (4) active cancer treatment; (5) participation in another interventional study for back pain.

Criteria

Inclusion Criteria:

Aged 65 years or older
Chronic low back pain, defined as back pain present on at least half the days in the past 6 months
Ability to speak English
Ability to attend study visits
Ability to provide informed consent

Exclusion Criteria:

Prior acupuncture treatment for low back pain in the past year
Conditions that preclude safe acupuncture or completion of the study (e.g., severe cognitive impairment)
Planned lumbar spine surgery within the next 6 months
Active cancer treatment
Participation in another interventional study for back pain