German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups

Haake, M.

Muller, H. H.

Schade-Brittinger, C.

Basler, H. D.

Schafer, H.

Maier, C.

Endres, H. G.

Trampisch, H. J.

Molsberger, A.

Archives of internal medicine

2007

167(17)

1892-1898

RCT

Acu Versus > 1 Control

Acupuncture

Back Pain

Penetrating Sham

Low Back Pain

Physical Therapy

RCT

Restricted Modalities, Acupuncture Only

Semi-Individualized Acupuncture Protocol

Superficial Needling Depth

Sham Acupoint Control

Sham Control

Usual Care Control, Multimodality

TCM Acupuncture Style

Traditional Diagnosis Based Point Selection

Low Back Pain, Chronic

BACKGROUND: To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain. METHODS: A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement. RESULTS: At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001. CONCLUSIONS: Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy

Back Pain

>1/WK

1162

5 Weeks