This policy has been updated periodically using the MedLine database, with the most recent literature update performed through May 2013. These literature searches have identified a limited number of studies evaluating patient outcomes with non-surgical spinal decompression traction devices.
Non-surgical spinal decompression traction devices are an expensive high-tech form of mechanical traction that provides relief in some cases of low back pain but it is widely promoted by manufacturers to correct degenerated and herniated discs without surgery. Non-surgical spinal decompression traction devices may provide relief for properly selected patients. However, there are reasons to believe that manual therapy can in most cases accomplish the same thing more quickly, safely, and less expensively. There have been no long term studies that show that patients that are helped initially by this traction device do not have to return for surgical intervention.
Randomized Controlled Trials: Results from a randomized sham-controlled trial of intervertebral axial decompression were published in 2009. (1) Sixty subjects with chronic symptomatic lumbar disc degeneration or bulging disc with no radicular pain and no prior surgical treatment (dynamic stabilization, fusion, or disc replacement) were randomly assigned to a graded activity program with an AccuSPINA device (20 traction sessions during six weeks, reaching >50% body weight) or to a graded activity program with a non-therapeutic level of traction (<10% body weight). In addition to traction, the device provided massage, heat, blue relaxing light, and music during the treatment sessions. Neither patients nor evaluators were informed about the intervention received until after the 14-week follow-up assessment, and intention-to-treat analysis was performed (93% of subjects completed follow-up). Both groups showed improvements in validated outcome measures (visual analog scores for back and leg pain, Oswestry Disability Index, and Short-Form 36), with no differences between the treatment groups. For example, visual analog scores for low back pain decreased from 61 to 32 in the active group and from 53 to 36 in the sham group. Evidence from this recent randomized controlled trial does not support an improvement in health outcomes with vertebral axial decompression.
Sherry and colleagues conducted a randomized trial comparing vertebral axial decompression (using the VAX-D® device) with transcutaneous electrical nerve stimulation (TENS). (2) While a 68% success rate was associated with vertebral axial decompression compared to a 0% success rate associated with TENS therapy, without a true placebo control, the results are difficult to interpret scientifically. In 2007, two small randomized trials (n=27, n=64) found little to no difference between patients treated with or without mechanical traction. (3, 4)
Non-randomized Comparative Studies: In 2004, Ramos reported a nonrandomized comparison of patients receiving 10 sessions versus 20 sessions of vertebral axial decompression treatment. (5) Patients receiving 20 sessions had a response rate of 76% versus a 43% response in those receiving 10 sessions. The study has several limitations and deficiencies; it is not randomized, the follow-up time is not stated, and it does not use a validated outcome measure.
Observational Studies: In 1998, Gose and colleagues reported on an uncontrolled case series of 778 patients. (6) Although this study reported improvements in pain, mobility, and activity in the majority of patients, the study did not detail methods of patient identification or collection of data and did not indicate the duration of treatment success. Finally, the study was uncontrolled.
In a 1994 study of 5 patients, Ramos and Martin reported that intradiscal pressure decreased during the treatment period. (7) Two case series in 2008 reported symptom improvement in patients with chronic low back pain. (7, 8) Due to limitations associated with observational studies of chronic pain, randomized controlled trials (RCTs) are needed to demonstrate efficacy of this treatment.
Evidence for the efficacy of non-surgical spinal decompression traction devices, including vertebral axial decompression on health outcomes is limited. Since a placebo effect may be expected with any treatment that has pain relief as the principal outcome, randomized trials with validated outcome measures are required to determine if there is an independent effect of active treatment. The only sham-controlled randomized trial published to date did not show a benefit of vertebral axial decompression services compared to the control group. Therefore, treatment with non-surgical spinal decompression traction devices, including the VAX-D® device, is considered experimental, investigational and unproven.
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