Is sham laser a valid control for acupuncture trials?
Multidisciplinary Pain Center, Department of Anaesthesiology, University of Munich, Pettenkoferstraße 8A, 80336 Munich, Germany.
Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.
Medical Acupuncture. 2010 March;22(1):11-17.
Clinical Equivalence of Laser Needle to Metal Acupuncture Needle in Treating Musculoskeletal Pain: A Pilot Study
Mayo Clinic Florida, Jacksonville, FL 32224, email@example.com
Background: Acupuncture methodology has evolved over millennia with the introduction of new technologies. Modern laser “needle” systems can transmit light energy deep enough through the skin to influence channel acupoints and trigger points.
Objectives: To compare whether musculoskeletal pain treatment outcomes with acupuncture are clinically equivalent whether using laser or traditional metal needles; and to determine statistical power estimates of cohort size for future double-blinded studies.
Design: Prospective nonblinded cohort study using neuroanatomically based point selection in a crossover protocol alternating between laser and metal needles.
Setting: Outpatient clinic at the Mayo Clinic Florida in Jacksonville, FL.
Participants: Thirty adults with degenerative joint or spine pain whose pain did not respond to allopathic interventions and were receiving metal needle acupuncture.
Intervention: Laser stimulation at prescribed neuroanatomically based acupoints was alternated at successive treatments with metal needles at the same points for 4 treatment sessions.
Main Outcome Measures: Visual Analog Scale (VAS) (0-10) pain rating, patient preference (metal vs laser), and treatment complications.
Results: For shoulder and knee arthritis pain, metal needle treatment pain VAS was 5.9 vs laser VAS of 3.1 (mean difference, 2.8; P=.05) Ninety percent (9/10) of participants with joint arthritis pain preferred laser treatments and reported more pain relief than similar treatments using metal needles; 80% (16/20) of spine pain participants reported the laser treatments provided at least as much pain relief as similar metal needle treatments. No laser treatment complications were noted.
Conclusions: This pilot study of participants with chronic refractory musculoskeletal pain demonstrates that when used in neuroanatomical acupuncture treatments, laser stimulation is preferred and provides superior pain relief compared with metal needle treatments of the same acupoints. The laser “needles” appear to be clinically equivalent to metal needles.”