Clinical trial NCT06750380: Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain
Official title: Comparative Effects of Mackenzie and Tailored Mat Exercises on Pain, Function and Disability in Post-Menopausal Women With Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain, Low
Keywords: exercises
disability
postmenopausal
women
chronic
low back pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 62
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue Scale
timeFrame: 10th week
measure: Roland-Morris disability questionnaire (RMDQ)
timeFrame: 10th week
measure: Timed up-and-go (TUG) test
timeFrame: 10th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: CMH (Combined Military Hospital)
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonseca LS, Silva JP, Souza MB, Mascarenhas RO, Silva HJ, Campos MGM, Pereira LSM, Oliveira MX, Oliveira VC. Efficacy of pharmacological and non-pharmacological therapy on pain intensity and disability of older people with chronic nonspecific low back pain: a protocol for a network meta-analysis. Syst Rev. 2023 Nov 7;12(1):205. doi: 10.1186/s13643-023-02369-0.
citation: Bais A, Mishra SA, Darda PP, Phansopkar P. Impact of 6 weeks pilates training on menopause specific symptoms and quality of life in menopausal women: a case report. Journal of Pharmaceutical Research International. 2021 Jul 19;33(37B):83-9.
citation: Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
citation: Ravindran AK, Javed J, Parthiban R, Sherrif B. Effectiveness of aerobic exercise versus pilates in postmenopausal women with non-specific chronic low back pain. Indian Journal of Physiotherapy & Occupational Therapy Print-(ISSN 0973-5666) and Electronic-(ISSN 0973-5674). 2022 Apr 13;16(2):1-8.
citation: Belli G, Esposito C, Campanella M, Vista E, Pegreffi F, Maietta Latessa P. Comparison of Core Stability versus McKenzie Exercises in people with low back pain: effects induced by 4 weeks of training on pain, flexibility and spine mobility. SPORT SCIENCES FOR HEALTH (ONLINE). 2022:45-.
citation: Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.