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Original Investigation
September 24, 2007

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

Author Affiliations

Author Affiliations: Orthopedic Department, University Of Regensburg, Bad Abbach, Germany (Dr Haake); Institutes For Medical Biometry And Epidemiology (Drs MüLler And SchäFer) And Medical Psychology (Dr Basler) And Centre For Clinical Trials (Ms Schade-Brittinger), Philipps-University Marburg, Marburg, Germany; Departments Of Pain Management, Bg-Kliniken Bergmannsheil (Dr Maier) And Medical Informatics, Statistics And Epidemiology, Ruhr-University Bochum, Bochum, Germany (Drs Endres And Trampisch); And Centre For Clinical Acupuncture And Research, DüSseldorf, Germany (Dr Molsberger).

Arch Intern Med. 2007;167(17):1892-1898. doi:10.1001/Archinte.167.17.1892
Abstract

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.

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