Actual or Simulated Acupuncture Therapy May Be Effective for Chronic Low Back Pain

May 20, 2009 — Actual or simulated acupuncture therapy appears to be more effective than usual care for chronic low back pain, according to the results of a randomized controlled trial reported in the May 11 issue of the Archives of Internal Medicine.

"Acupuncture is a popular complementary and alternative treatment for chronic back pain," write Daniel C. Cherkin, PhD, from the Center for Health Studies in Seattle, Washington, and colleagues. "Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain."

In this study, 638 adults with chronic mechanical low back pain were assigned to receive individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. All acupuncture groups received 10 treatments administered by experienced acupuncturists during a 7-week period. The main endpoints of the study were back-related dysfunction measured with the Roland-Morris Disability Questionnaire (scored 0 - 23) and symptom bothersomeness (scored 0 - 10), evaluated at baseline and after 8, 26, and 52 weeks.

At 8 weeks, improvements in mean dysfunction scores were 2.1 points for those receiving usual care, 4.4 points for individualized acupuncture, 4.5 points for standardized acupuncture, and 4.4 points for simulated acupuncture (P < .001). Compared with participants receiving usual care, those receiving real or simulated acupuncture were more likely to achieve clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001).

In the usual-care group, symptoms improved by 0.7 points vs 1.6 to 1.9 points in the treatment groups (P < .001). Clinically meaningful improvements in dysfunction persisted in the treatment groups vs the usual-care group after 1 year (59% - 65% vs 50%, respectively; P = .02), but symptom improvements were not significantly different among groups (P > .05).

"Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits," the study authors write. "These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide[s] physiologically important stimulation or represent[s] placebo or nonspecific effects."

Limitations of this study include restricting treatment to only the needling component of traditional Chinese acupuncture, predetermined number and duration of treatments, limited conversation between the acupuncturists and the patients, and lack of a medical care comparison group.

"The reduction in long-term exposure to the potential adverse effects of medications is an important benefit that may enhance the safety of conventional medical care," the study authors write. "The number of patients who would need to be treated with insertive or superficial acupuncture stimulation to result in 1 person achieving meaningful improvement in function ranges from 5 (for short-term benefits) to 8 (for persisting benefits)."

A National Institutes of Health Cooperative Agreement with the National Center for Complementary and Alternative Medicine funded this study. Lhasa OMS, Inc, Weymouth, Massachusetts, donated the Seirin acupuncture needles used in this study. The study authors have disclosed no relevant financial relationships.

Arch Intern Med. 2009;169:858-866.

Clinical Context

Back pain is the leading reason for visits to licensed acupuncturists. Recent studies suggest that sham and actual acupuncture are similarly effective in patients with low back pain and superior to usual care and wait-list control.

This is a 4-group randomized controlled trial of patients with chronic low back pain at 2 integrated health delivery systems in the United States to compare the effectiveness of the procedures vs one another and vs usual care.

Study Highlights

• Included were patients aged 18 to 70 years receiving care for low back pain from an integrated health delivery system in Washington state and California.
• Electronic records were used to identify patients with uncomplicated low back pain for the past 3 to 12 months.
• Participants had to have a rating of at least 3 of 10 on the back pain bothersomeness scale.
• Excluded were those with specific causes of low back pain, complicated back problems, contraindications for acupuncture, less than 3 months of back pain, and conditions that might confound results of acupuncture treatment.
• 638 participants were allocated to 1 of 4 groups: individualized acupuncture (n = 157), standard acupuncture (n = 158), simulated acupuncture (n = 162), or usual care (n = 161).
• The individualized group was evaluated by diagnosticians with 7 to 18 years' experience with acupuncture who prescribed individualized Chinese medical treatments, which were then delivered by therapists.
• Therapists delivered the treatments using 18-gauge needles retained for 18 minutes and 74 potential distinct points.
• The standardized group received treatment at 8 points on the lower back and lower leg and were needled for 20 minutes to achieve "de qi"; the needles were twirled for 10 minutes before withdrawal.
• The simulated group received a simulated insertion with a needle guide tube containing a toothpick to imitate the process of inserting the needle to a proper depth.
• 10 treatments per person were offered.
• The usual-care group received no study-related care.
• All participants received a self-care book.
• Primary outcome were back-related symptoms and symptom bothersomeness by the modified Roland-Morris Disability Questionnaire and the bothersomeness scale (0 - 10).
• Secondary outcomes were 26- and 52-week outcomes, physical and mental health components of the Medical Outcomes Study Short-Form 36 Health Survey quality-of-life scale, number of days in bed, number of days lost from work or school, medication use for low back pain, and health service use.
• Mean age was 47 years, 62% were women, 68% were white, and 53% were college graduates.
• Low back pain was moderately bothersome, and two thirds reported at least 1 year of pain and current medication use for pain.
• Participants were moderately optimistic that acupuncture would help (6.7 on a 0 - 10 scale).
• Adherence, defined as completion of 8 or more treatments, was 84% to 90% in the 3 acupuncture groups.
• All groups showed improved function at 8 weeks with an improvement of 4.4 to 4.5 points on the Roland-Morris Disability Questionnaire for all acupuncture vs 2.1 points for the usual-care group.
• The 3 acupuncture groups did not differ in effectiveness for function.
• Superior functional outcomes for the 3 acupuncture groups vs usual care were maintained at 26 weeks (P = .01) and 52 weeks (P = .02).
• By 52 weeks, differences for bothersomeness in the 4 groups were no longer significant.
• Use of medications was lower in the 3 acupuncture groups (47%) vs the usual-care group (59%).
• There were small differences in the Medical Outcomes Study Short-Form 36 Health Survey for both physical and mental components, with the acupuncture groups being superior, but these disappeared by 52 weeks.
• More participants in the usual-care group took days off work or school in the previous month.
• The usual-care group was more likely to report clinician or physical therapist visits (21% vs 11%; P = .001) or visits to a complementary and alternative medicine provider (18% vs 8%; P < .001).
• There were no differences among the 3 acupuncture groups.
• No cost savings were associated with acupuncture.

Clinical Implications

• Use of any of 3 types of acupuncture treatment is associated with superior outcomes of bothersomeness and improved function vs usual care during 8 weeks.
• Individualized, standard, and simulated acupuncture are similarly associated with superior outcomes of medication use, function, and use of health services vs usual care.

Source : http://cme.medscape.com/viewarticle/703032?src=mpnews&spon=34&uac=133298AG