- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750380
Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain
Comparative Effects of Mackenzie and Tailored Mat Exercises on Pain, Function and Disability in Post-Menopausal Women With Chronic Nonspecific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 6400
- CMH (Combined Military Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue Scale
Time Frame: 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.
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10th week
|
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Roland-Morris disability questionnaire (RMDQ)
Time Frame: 10th week
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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
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10th week
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Timed up-and-go (TUG) test
Time Frame: 10th week
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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
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10th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hina gul, MSOMPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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-.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Organizing Pneumonia
- Pain
- Neurologic Manifestations
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Back Pain
- Bronchiolitis Obliterans
- Bronchiolitis
- Bronchitis
- Graft vs Host Disease
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Bronchiolitis Obliterans Syndrome
- Low Back Pain
- Motor Activity
Other Study ID Numbers
- REC/RCR&AHS/24/0527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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