Clinical trial NCT01987622: Acupuncture for Lumbar Spinal Stenosis
Official title: Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Keywords: lumbar spinal stenosis
claudication
low back pain
radiculopathy
acupuncture
Korean medicine
randomized controlled trial
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2013-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).


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

Primary outcomes:
measure: Mid-term Back specific functional status
timeFrame: 3 months
Secondary outcomes:
measure: Short-term Back specific functional status
timeFrame: 6 weeks
measure: Short-term low back pain bothersomeness
timeFrame: 6 weeks
measure: Mid-term low back pain bothersomeness
timeFrame: 3 weeks
measure: Short-term low back pain intensity
timeFrame: 6 weeks
measure: Mid-term low back pain intensity
timeFrame: 3 weeks
measure: Short-term leg pain bothersomeness
timeFrame: 6 weeks
measure: Mid-term leg pain bothersomeness
timeFrame: 3 months
measure: Short-term leg pain intensity
timeFrame: 6 weeks
measure: Mid-term leg pain intensity
timeFrame: 3 months
measure: Short-term pain-related quality of life
timeFrame: 6 weeks
measure: Mid-term pain-related quality of life
timeFrame: 3 months
measure: Short-term physical function-related quality of life
timeFrame: 6 weeks
measure: Mid-term physical function-related quality of life
timeFrame: 3 months
measure: Self-reported pain-free walking distance
timeFrame: 6 weeks, 3 months
measure: Patient satisfaction for treatment outcome
timeFrame: 6 weeks, 3 months
measure: Patient Global Assessment for treatment outcome
timeFrame: 6 weeks, 3 months
measure: Use of medication and healthcare resources
timeFrame: 6 weeks, 3 months
measure: Adverse events
timeFrame: 6 weeks, 3 months
Other outcomes:
measure: Participant expectancy for allocated treatments
timeFrame: Baseline, 6 weeks, 3 months
Locations:
city: Yangsan
country: Korea, Republic of
facility: National Clinical Research Center, Korean Medicine Hospital, Pusan National University
state: Kyungsangnamdo
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Gi Young Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KH, Kim YR, Baik SK, Noh SH, Kim DH, Lee SW, Yang GY. Acupuncture for patients with lumbar spinal stenosis: a randomised pilot trial. Acupunct Med. 2016 Aug;34(4):267-74. doi: 10.1136/acupmed-2015-010962. Epub 2016 Mar 7.