Design Of A Novel Lumbar Traction Device

Abstract

Lower back pain (LBP) is the leading global cause of disability, with 619 million cases in 2020 projected to rise to 843 million by 2050. The societal and economic burden is substantial; in the UK, the National Health Service spends over £5 billion yearly on back-related care, while in the USA, costs from 2012 to 2014 for patients with a spine condition were $315 billion USD. Current treatments are limited, surgery is invasive and costly, while medication such as opioids offers only short-term relief with uncertain long-term benefit and considerable side effects. Spinal traction is widely used as a non-invasive treatment. It may alleviate pain through spinal decompression and improved
disc health, but existing devices are often expensive, uncomfortable, or require supervised use in a clinic.
This thesis describes the design, development, and evaluation of a novel traction device for the treatment of LBP, which is affordable, user-friendly, and suitable for unsupervised usage in physiotherapy practices or at home. A patient study of an early seated prototype (Prototype 2) with 20 patients revealed limitations in fixation and comfort: four patients could not be tested due to slipping through the belt fixation, and six of the remaining patients were unable to complete the 10-minute treatment. On average, patients reported only a slight reduction in pain (∆V AS of 0.47 ± 2.60), and a significant negative correlation was found between treatment-related discomfort and pain reduction (r = −0.57, p = 0.022).
Furthermore, market research at YES!Delft indicated that Prototype 2 would be too costly for the intended users. To optimize therapy, a literature review was conducted to determine how the therapist controlled parameters, specifically force, body position, and duration, to assess their potential influence on the treatment effect. The review suggested that traction is most effective at forces of < 20% body weight (increasing up to 40% if necessary), in prone or supine 90/90 positions, and with intermittent traction cycles lasting 10-20 minutes. Additional factors influencing outcomes included patient age, duration of symptoms, presence of sciatica, and timing of follow-up.
Based on these findings, a third prototype was developed and evaluated in a patient study comprising six treatments over a six-week period. The control group (n = 4) received manual traction in combination with mobilization and detonizing (which is standard physiotherapy treatment) and in the study group (n = 6) manual traction was replaced with treatment by Prototype 3. Both groups reported reductions in pain (VAS) and disability (ODI), with statistically significant improvement observed only in the study group (p = 0.0216). No significant differences between groups were detected, though effect sizes indicated individual improvement. These results demonstrate the viability of a patient-operated traction device and suggest therapeutic potential comparable to that of current physiotherapy treatments and reported literature. While further research with larger study groups and refined design parameters is needed, the device shows promise as a cost-effective solution for use in physiotherapy practices or home settings.