NCT01987622

Acupuncture for Lumbar Spinal Stenosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Korean Medicine Hospital of Pusan National University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2013-11-19
• Last updated: 2015-02-09

Locations

1 site across 1 country: South Korea