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临床试验/NCT06750380
NCT06750380已完成不适用

Comparative Effects of Mackenzie and Tailored Mat Exercises on Pain, Function and Disability in Post-Menopausal Women With Chronic Nonspecific Low Back Pain

Riphah International University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Visual analogue Scale

研究概览

简要总结

Group A will receive tailored mat exercises. Group B will receive Mckenzie exercises. A baseline treatment including moist hot pack and TENS will be given to both of these groups. All these sessions will be of 45 minutes for 2 session per week for 10 weeks.

详细描述

Exercise has been shown to reduce pain and improve function levels in postmenopausal women with chronic NSLBP. McKenzie method is a well-known method used in the treatment of LBP. Another method of therapeutic exercise that has shown some positive results is the Pilates method. Existing research shows that Pilates in adult women with chronic NSLBP reduces pain and disability and improves the quality of life. However, the effect of Pilates and Mckenzie exercises in postmenopausal women with chronic NSLBP remains under investigation. This study aims to examine comparative effects of Mackenzie and tailored mat exercises on pain, function and disability in post-menopausal women with chronic nonspecific low back pain and will help in providing improvements in pain and disability and hence better quality of life.

This will be a randomized Clinical trial conducted on 62 participants. Data will be collected from Combined Military Hospital Lahore, by using non-probability convenience sampling technique. Postmenopausal Women between the age of 55 to 85 with Chronic NSLBP for more than 12 weeks, a physician referral for exercise, a pain VAS score>30 mm and≤70 mm, and (TUG) test score>15 will be included in this study. Participants who are frailer, have radicular referred leg pain, radiculopathy, low back pain due to a serious pathology participation in another lower back specific exercise program in the last 6 months, participation in a previous Pilates exercise program, neurodegenerative disease, recent stroke, and cognitive impairment (Mini Mental State Exam score < 24) will be excluded from this study. A sample of 62 will be divided into two groups with 31participants in each group. Group A will receive tailored mat exercises. Group B will receive Mckenzie exercises. A baseline treatment including moist hot pack and TENS will be given to both of these groups. All these sessions will be of 45 minutes for 2 session per week for 10 weeks. Primary outcomes included will be visual analog scale (VAS) for pain, Roland-Morris Disability Questionnaire (RMDQ), timed up-and-go (TUG), at baseline, 10 weeks, and 6 months post-interventions. Data will be analyzed by using SPSS version 26.0.

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 (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •chronic nonspecific low back pain (more than 12 weeks)
  • •Moderate pain VAS>30mm and< 70mm
  • •TUG score of < 15s
  • •Female who had entered menopause (menstrual periods have stopped for 12 months)
  • •Stable vital signs (patient is stable and vital signs are within normal limits)
  • •Multigravida

排除标准

  • •Frailer individuals
  • •Radiculopathy (signs of sensory loss, muscle weakness, reduced tendon reflexes)
  • •Women suffering from pathological conditions for example cardiac disease, cancer, vertebral fracture, osteomyelitis, Rheumatoid arthritis, cauda equina syndrome) participation in another lower back specific exercise program in the last 6 months
  • •Participation in a previous Pilates exercise program
  • •Neurodegenerative disease (e.g., Parkinson's disease)
  • •Recent stroke and cognitive impairment (Mini Mental State Exam score < 24)
  • •History of recent fracture

研究组 & 干预措施

Tailored mat exercise program

Experimental

The Group A will receive TENS plus moist hot pack and follow the Tailored mat exercise program for 10 weeks, two times per week, in 45-min sessions under supervision of trained physical therapist. The choice of exercises will be made based on the suggested exercises of Wood for the treatment of back pain, while the easiest versions of each exercise would be selected in order for the program to be adapted to older adults. Patient's outcomes will be measured at baseline and after 10 weeks.

干预措施: Tailored mat exercise program (Other)

McKenzie exercises

Active Comparator

The Group B will receive McKenzie exercises plus moist hot pack and TENS in the region of lumbar spine for 10 minutes and Mckenzie exercises of seven to ten repetitions for 45 min/session two times per week for ten weeks. Patient's outcomes will be measured at baseline and after 10 weeks

干预措施: McKenzie exercises (Other)

结局指标

主要结局

Visual analogue Scale

时间窗: 10th week

Pain experienced in the last 24 h will be assessed with the pain VAS. The scale is an unnumbered 100 mm line, one end of which has the phrase "no pain" and the other "maximum pain". A mark is placed by the patient at a point representing their pain level. That mark is then measured by the tester with a millimeter ruler. Each measurement of the pain VAS corresponded to pain experienced in the last week, with lower values indicating less pain. The pain VAS is the most commonly used instrument for measuring low back pain intensity and its use is indicated in older adults It has high reliability with an intraclass correlation coefficient (ICC) of 0.99.

Roland-Morris disability questionnaire (RMDQ)

时间窗: 10th week

Roland-Morris disability questionnaire (RMDQ) The Greek version of the RMDQ was used to assess disability associated with low back pain in the last 24 h. This questionnaire has shown high test-retest reliability in older adults, with an intraclass correlation coefficient (ICC) of 0.85. The RMDQ consists of 24 items related to the daily activities patients often report having difficulty performing due to low back pain. Every positive answer earns one point; the final score is the total sum. The higher the score, the greater is the limitation

Timed up-and-go (TUG) test

时间窗: 10th week

The TUG is a performance-based measure of functional mobility initially developed to identify mobility and balance impairments in older adults. The TUG has demonstrated high interrater and intrarater reliability when used to examine older adults (ICC=0. 99). The patient is scored based on the time required to perform the following sequence of actions: stand up from a chair, walk at their own pace a distance of 3 m to a marked spot on the floor, turn around, return to the chair and sit back down

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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