Acupuncture for Lumbar Spinal Stenosis

NCT ID: NCT01987622

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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).

Conditions

Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

A series of acupuncture sessions within six weeks from the baseline

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

Usual care

Intervention Type: 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.

Usual care

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

Acupuncture

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.

Intervention Type: PROCEDURE

Usual care

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Gi Young Yang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gi Young Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital, Pusan National University

Locations

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

Yangsan, Kyungsangnamdo, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26953235 (View on PubMed)

Other Identifiers

KIOM

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Acustenosis

Identifier Type: -

Identifier Source: org_study_id