Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain

Riphah International University

Status: Enrolling

Conditions: Back Pain, Low

Treatments: Other: McKenzie exercises; Other: Tailored mat exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06750380

REC/RCR&AHS/24/0527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Tailored mat exercise program

Experimental group

Description:

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.

Treatment:

Other: Tailored mat exercise program

McKenzie exercises

Active Comparator group

Description:

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

Treatment:

Other: McKenzie exercises