Efficacy and safety of thermobalancing therapy with Dr Allen's Device for chronic low back pain: A randomised controlled trial.

Abstract

Background: Lumbar disc herniation and non-specific low back pain are common conditions that seriously affect patients' health-related quality of life (HRQoL). Although empirical evidence has demonstrated that novel Thermobalancing therapy and Dr Allen's Device can relieve chronic low back pain, there have been no randomised controlled trials for these indications.

Aim: To evaluate the efficacy of Dr Allen's Device in lumbar disc herniation (LDH) and non-specific low back pain (NSLBP).

Methods: A randomised clinical trial was conducted investigating 55 patients with chronic low back pain due to LDH (n = 28) or NSLBP (n = 27), out of which 15 were randomly assigned to the control group and 40 were assigned to the treatment group. The intervention was treatment with Dr Allen's Device for 3 mo. Changes in HRQoL were assessed using the Numerical Pain Rating Scale and the Japanese Orthopedic Association Back Pain Questionnaire.

Results: Thermobalancing therapy with Dr Allen's Device showed a significant reduction in pain in the treatment group (P < 0.001), with no recorded adverse effects. Both pain assessment scales showed a significant improvement in patients' perception of pain indicating improvement in HRQoL.

Conclusion: The out-of-hospital use of Thermobalancing therapy with Dr Allen's Device for Low Back Treatment relieves chronic low back pain significantly and without adverse effects, improves the level of activity and HRQoL among patients with LDH and NSLBP. This study demonstrates the importance of this safe first-line therapy that can be used for effective at-home management of chronic low back pain.