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临床试验/IRCT20211022052833N2
IRCT20211022052833N2已完成Unknown

Thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain due to lumbar disc herniation or non-specific low back pain

Fine Treatment0 个研究点目标入组 54 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
54

研究概览

简要总结

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. Allen S, Rashid A, Adjani A, Akram M, Khan FS, Sherwani R, Khalil MT. Efficacy and safety of thermobalancing therapy with Dr Allen’s Device for chronic low back pain: A randomised controlled trial. World J Orthop 2023; 14(12): 878-888 [PMID: 38173805 DOI: 10.5312/wjo.v14.i12.878]

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 70 years(—)
性别
All

入选标准

  • Subjects, age greater than 18 years and less than 70 years with chronic low back pain
  • Subjects with diagnosis of lumbar disc herniation or nonspecific low back pain

排除标准

  • Subjects with lumbar spinal stenosis, lumbar spondylolisthesis, lumbar scoliosis, or a history of lumbar spine surgery
  • Subjects with severe comorbidities including cancer, heart failure and chronic infectious diseases

研究者

发起方
Fine Treatment

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