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临床试验/NCT06425744
NCT06425744已完成不适用

The Effect of Self-Myofascial Release and Pilates Reformer Exercise on Pain, Muscle Function and Quality of Life in Women With Chronic Low Back Pain

Sahmyook University2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2022年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Pain severity

研究概览

简要总结

The aim of this study is to find out if Reformer Pilates and self-myofascial release are effective for pain and muscle function in women with chronic low back pain. Investigators will also look at changes in quality of life. The main questions for the study are

Can Reformer Pilates and self-myofascial release reduce pain in participants? Can Reformer Pilates and self-myofascial release change muscle function in participants? The researchers want to compare the effects of Reformer Pilates and self-myofascial release in women with chronic low back pain.

Participants will be

Group 1 Perform Reformer Pilates and self-myofascial release exercises twice a week for 6 weeks, for a total of 12 sessions.

Group 2 Perform Reformer Pilates exercises twice a week for 6 weeks, for a total of 12 sessions.

Participants will visit the Pilates Centre for an examination before and once after starting the programme.

All groups perform a home exercise training programme for 15 minutes three times a week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • People who have had chronic low back pain for 12 weeks or more
  • Have a Korean Oswestry Disability Index (KODI) score of 17% or higher

排除标准

  • Patients with low back pain due to trauma, neurological lesions of the lower extremities, herniated disc lesions, hip, pelvic or abdominal surgery
  • Patients who have received radiation or injections within the last 3 months,
  • Pregnant women or patients who have given birth within the last year

结局指标

主要结局

Pain severity

时间窗: From enrollment to the end of treatment at 6 weeks

Pain severity is measured using a visual analogue scale, where participants mark the level of back pain they feel on a line between 0 mm and 100 mm(0: no pain, 10: worst pain imaginable). Measurement unit is in mm, with higher scores considered more painful

Functional disability caused by low back pain

时间窗: From enrollment to the end of treatment at 6 weeks

The Korean version of the Oswestry Disability Index (KODI) is used to assess functional impairment due to low back pain. This assessment consists of 10 items, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel, with each item scored on a scale of 0 to 5 for a total of 50 points. The KODI score is given as a percentage (%) of the total score. Scores are categorised as mild disability (0-20%), moderate disability (21-40%), severe disability (40-60%) and disability affecting all aspects of life (\>60%), with high test-retest reliability (r=0.92).

次要结局

  • Quality of life questionnaire(From enrollment to the end of treatment at 6 weeks)
  • Flexibility of lower back and hamstring(From enrollment to the end of treatment at 6 weeks)
  • Muscular endurance(From enrollment to the end of treatment at 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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