Acupuncture for Lumbar Spinal Stenosis

NCT01987622 | Completed DMC

• 2 other identifiers: AcustenosisKIOM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Stenosis

Keywords

lumbar spinal stenosis; claudication; low back pain; radiculopathy; acupuncture; Korean medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mid-term Back specific functional status

  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.

  3 months

Secondary Outcomes (18)

• Short-term Back specific functional status

  6 weeks

• Short-term low back pain bothersomeness

  6 weeks

• Mid-term low back pain bothersomeness

  3 weeks

• Short-term low back pain intensity

  6 weeks

• Mid-term low back pain intensity

  3 weeks

Other Outcomes (1)

• Participant expectancy for allocated treatments

  Baseline, 6 weeks, 3 months

Study Arms (2)

Acupuncture

EXPERIMENTAL

A series of acupuncture sessions within six weeks from the baseline

Procedure: Acupuncture; Procedure: Usual care

Usual care

ACTIVE COMPARATOR

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.

Procedure: Usual care

Interventions

Acupuncture PROCEDURE

The patients in this group will receive individualized acupuncture prescribed by a certified Korean Medicine Doctor (KMD) with at least three years of clinical experience. The acupuncture formulas will be determined based on the individual patient's symptoms and at the KMD's discretion. The acupuncture treatment will be applied one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). Acupuncture will be manually stimulated at first, and then electrical stimulation will be allowed at the KMD's discretion. Retention time will be equal to or less than 20 minutes. Examples of acupuncture points to be used might include LI4, LI11, TE5, SI3, TE3, ST36, SP6, SP9, LR3, GB34, Gb39, BL40, BL57, EX-B2, and BL23.

Acupuncture

Usual care PROCEDURE

Usual care consists of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed. Participants will receive a three-page leaflet of patient education material. Optional regular physical therapies, including interferential current therapy (ICT) and local heat application, will be provided only for the control group at the participants' request . Physical therapy will be provided one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). All kinds of conservative interventions for lumbar spinal stenosis, including analgesics and non-study physical treatments,will be allowed. However, surgical treatments, non-study acupuncture, or herbal medicine will not be allowed.

Acupuncture; Usual care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Yangsan, Kyungsangnamdo, 626-770, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26953235 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Intermittent Claudication; Low Back Pain; Radiculopathy

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gi Young Yang, PhD

  Korean Medicine Hospital, Pusan National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

KR (1)