Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain
NCT ID: NCT06750380
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
62 participants
INTERVENTIONAL
2024-08-01
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tailored mat exercise program
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.
Tailored mat exercise program
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.
McKenzie exercises
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
McKenzie exercises
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tailored mat exercise program
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.
McKenzie exercises
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
55 Years
85 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riphah International University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
hina gul, MSOMPT
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CMH (Combined Military Hospital)
Lahore, Punjab Province, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
hina gul, MSOMPT
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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-.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REC/RCR&AHS/24/0527
Identifier Type: -
Identifier Source: org_study_id