Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison

Korean Medicine Hospital of Pusan National University1 site in 1 country50 target enrollmentNovember 2013

ConditionsSpinal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Stenosis
Sponsor: Korean Medicine Hospital of Pusan National University
Enrollment: 50
Locations: 1
Primary Endpoint: Mid-term Back specific functional status
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor adverse events. However, little information exists regarding the effects and safety of acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present chronic low back and leg pain.

The investigators aimed to assess the overall effectiveness, safety, and feasibility of acupuncture in combination with usual care (as opposed to usual care alone) for patients with symptomatic degenerative lumbar spinal stenosis.

The hypotheses of this study are as follows:

A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
A set of acupuncture sessions in combination with usual care can provide greater pain reduction than usual care alone .

The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual care group).

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Korean Medicine Hospital of Pusan National University

Responsible Party

Principal Investigator

Gi Young Yang

Assistant Professor

Korean Medicine Hospital of Pusan National University

Eligibility Criteria

Inclusion Criteria

•Aged over 40
•Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)
•Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes
•Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years
•Willingness to participate in the study

Exclusion Criteria

•Congenital spinal stenosis
•Other spinal deformities, including spinal fractures and infections
•Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases
•Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)
•Comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis)
•Past/present history of malignancy
•Began a new intervention for the management of lumbar spinal stenosis within the last one month
•Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery
•Other conditions not appropriate for study participation

Outcomes

Primary Outcomes

Mid-term Back specific functional status

Time Frame: 3 months

Participant-perceived reduction of pain and physical function will be measured with a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.