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临床试验/NCT02887430
NCT02887430Unknown早期 1 期

The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain

Universiti Sultan Zainal Abidin0 个研究点目标入组 100 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
100
主要终点
mean time in days to the recovery of pain

研究概览

简要总结

The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.

详细描述

Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been medically diagnosed with a non-specific low back pain.
  • Have not received treatment for low back pain within the previous 2 weeks.
  • Are at least 18 years old.
  • Have both feet and all toes intact and free from wounds.
  • Have not undergone any other complementary and alternative therapies during the study.

排除标准

  • Have severe coexistent disease and serious pathology or systemic illness.
  • Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).
  • Have plantar fasciitis.
  • Lack the ability to read and write Malaysia language.
  • Had plans to move out of the area.

结局指标

主要结局

mean time in days to the recovery of pain

时间窗: 5 months

the mean time in days to the recovery of pain is measured at the first day the patient scores 0 to 10 point on the visual analog scale (VAS)

次要结局

  • demographic information(3 month)
  • side effects of treatment(5 month)
  • health-related quality of life(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nor dalila marican

Principle investigator

Universiti Sultan Zainal Abidin

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