The spine journal : official journal of the North American Spine Society
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Spinal manipulative therapy (SMT) has been attributed with substantial non-specific effects. Accurate assessment of the non-specific effects of SMT relies on high-quality studies with low risk of bias that compare with appropriate placebos. ⋯ Imperfect placebos are ubiquitous in clinical trials of LP-SMT, and few trials have assessed for successful subject blinding or balanced expectations of treatment success between active and control group subjects. There is thus a strong potential for unmasking of control subjects, unequal non-specific effects between active and control groups, and non-inert placebos in existing trials. Future trials should consider assessing the success of subject blinding and ensuring inertness of their placebo a priori, as a minimum standard for quality.
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Recently, there has been increased public awareness of regulatory actions by the United States Food and Drug Administration (FDA) on spinal devices. There has also been increased scrutiny of the pivotal clinical trials of these devices. ⋯ There has been no decrease in the number of new FDA-approved class III spinal devices since the turn of the century. The majority of devices have been for cervical arthroplasty. By contrast, biologic devices were most likely to go to panel and least likely to be approved after panel. The pivotal trials for nearly all devices were randomized, two-arm, noninferiority trials.
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In 2008, the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders (Neck Pain Task Force) found limited evidence on the effectiveness of manual therapies, passive physical modalities, or acupuncture for the management of whiplash-associated disorders (WAD) or neck pain and associated disorders (NAD). ⋯ Our review adds new evidence to the Neck Pain Task Force and suggests that mobilization, manipulation, and clinical massage are effective interventions for the management of neck pain. It also suggests that electroacupuncture, strain-counterstrain, relaxation massage, and some passive physical modalities (heat, cold, diathermy, hydrotherapy, and ultrasound) are not effective and should not be used to manage neck pain.
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In 2008, the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders (Neck Pain Task Force) found limited evidence on the effectiveness of manual therapies, passive physical modalities, or acupuncture for the management of whiplash-associated disorders (WAD) or neck pain and associated disorders (NAD). ⋯ Our review adds new evidence to the Neck Pain Task Force and suggests that mobilization, manipulation, and clinical massage are effective interventions for the management of neck pain. It also suggests that electroacupuncture, strain-counterstrain, relaxation massage, and some passive physical modalities (heat, cold, diathermy, hydrotherapy, and ultrasound) are not effective and should not be used to manage neck pain.
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Little is known about the effectiveness of multimodal care for individuals with whiplash-associated disorders (WAD) and neck pain and associated disorders (NAD). ⋯ Multimodal care can benefit patients with WAD and NAD with early or persistent symptoms. The evidence does not indicate that one multimodal care package is superior to another. Clinicians should avoid high utilization of care for patients with WAD and NAD.