Abstract and Introduction
In this randomized clinical trial, we examined whether the effect of true acupuncture can be differentiated from sham acupuncture (pain and functionality) by analyzing quantitative sensory testing (QST) profiles in chronic pain participants. We recruited 254 healthy or chronic back and neck pain participants. Healthy subjects were included to control for a possible effect of acupuncture on baseline QST changes. Study participants received 6 sessions (twice weekly) of true acupuncture, sham acupuncture, or no acupuncture treatment (routine care). Quantitative sensory testing profiles, pain scores, and functionality profile were obtained at baseline (visit 1) and after 3 (visit 4) or 6 sessions (visit 7). A total of 204 participants were analyzed. We found no QST profile changes among 3 groups (P = 0.533 and P = 0.549, likelihood ratio tests) in either healthy or chronic pain participants. In chronic back and neck pain participants, true acupuncture reduced pain (visit 4: difference in mean [DIM] = –0.8, 95% confidence interval [CI]: –1.4 to –0.1, adjusted P = 0.168; visit 7: DIM = –1.0, 95% CI: –1.7 to –0.3, adjusted P = 0.021) and improved functional status including physical functioning (DIM = 14.21, 95% CI: 5.84–22.58, adjusted P = 0.003) and energy/fatigue (DIM = 12.28, 95% CI: 3.46–21.11, adjusted P=0.021) as compared to routine care. Our results indicate that QST was not helpful to differentiate between true acupuncture and sham acupuncture (primary outcome) in this study, although true acupuncture reduced pain and improved functionality (secondary outcomes) when compared with routine care.
In recent years, acupuncture has gained in popularity as a useful modality of complementary, alternative, and integrative medicine for many clinical conditions, but its clinical utility remains uncertain. Acupuncture has long been used for chronic pain management, but its clinical outcome remains uncertain. Studies have indicated that methodological differences exist regarding the quality of clinical trials evaluating nonpharmacological (eg, acupuncture) vs pharmacological therapies, and this difference might be improved by introducing standard reporting of acupuncture trials. However, a fundamental difference in theories and practices between conventional western medicine and alternative medicine such as acupuncture is that western medicine is typically based on known mechanisms and molecular targets (eg, receptors, enzymes, and large molecules), whereas most forms of alternative medicine including acupuncture lack a mechanistic clarity. Therefore, a reasonable question to be asked is whether the clinical effectiveness of acupuncture, which is based on theories essentially different from those of western medicine and relies heavily on the physician–patient relationship and patients' own belief in the treatment, could be appropriately assessed by the trial methods such as placebo control used to study western medicine.
In this study, we examined whether the effect of true acupuncture can be differentiated from sham acupuncture by analyzing quantitative sensory testing (QST) profiles, a primary outcome, in addition to pain score and functionality (SF-36) profile (secondary outcomes), in chronic pain participants. Quantitative sensory testing is a well-recognized psychophysical outcome measure and has been extensively used for pain assessment in both research and clinical practice,[6,22,29] in addition to biomarker analysis.[3,9,14,23] Our hypothesis is that if acupuncture improves pain by modulating the underlying nociceptive processing, the effect of true acupuncture would be separable from that of sham acupuncture with regard to QST profiles (primary outcomes) as well as pain reduction and functional improvement (secondary outcomes).
Pain. 2019;160(11):2456-2463. © 2019 International Association for the Study of Pain