Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain
- Conditions
- Back Pain, Low
- Registration Number
- NCT06750380
- Lead Sponsor
- Riphah International University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual analogue Scale 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) 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMH (Combined Military Hospital)
🇵🇰Lahore, Punjab, Pakistan