Acupuncture for Lumbar Spinal Stenosis

Korean Medicine Hospital of Pusan National University

Status: Completed

Conditions: Spinal Stenosis

Treatments: Procedure: Acupuncture; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01987622

KIOM (Other Grant/Funding Number)

Acustenosis

Details and patient eligibility

About

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:

1. A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
2. 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).

Enrollment: 50 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Acupuncture

Experimental group

Description:

A series of acupuncture sessions within six weeks from the baseline

Treatment:

Procedure: Acupuncture

Procedure: Usual care

Usual care

Active Comparator group

Description:

An intervention consisting of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed.

Treatment:

Procedure: Usual care