Back Pain, LowNCT06750380
Effects of Mackenzie and Tailored Mat Exercises in Post-Menopausal Women With Low Back Pain
A study testing Tailored mat exercise program and McKenzie exercises in people with Back Pain, Low, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- Tailored mat exercise program and McKenzie exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
CMH (Combined Military Hospital)
Lahore, Punjab Province, 6400
About this study
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
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.
Read the 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.
- Conditions
- Back Pain, Low
- Being tested
- Tailored mat exercise program, McKenzie exercises
- Keywords
- exercises, disability, postmenopausal, women, chronic, low back pain
- Medical subject headings
- Low Back Pain, Motor Activity, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored mat exercise programOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored mat exercise program | Experimental | 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. Receives: Other: Tailored mat exercise program |
| McKenzie exercises | Active comparator | 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 Receives: Other: McKenzie exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue Scale
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.
Measured: 10th week
Roland-Morris disability questionnaire (RMDQ)
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
Measured: 10th week
Timed up-and-go (TUG) test
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
Measured: 10th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750380
- Sponsor's protocol ID
- REC/RCR&AHS/24/0527
- Status last verified
- Feb 2026
- First submitted
- 20 Dec 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37936147Bais 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.
PubMed 35507483Ravindran 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.
PubMed 33591367
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06750380
- Acronym / sponsor ID
- REC/RCR&AHS/24/0527
- Conditions
- Back Pain, Low
- Keywords
- exercises, disability, postmenopausal, women, chronic, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored mat exercise program | Experimental | Other: Tailored mat exercise programThe 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 | Active comparator | Other: McKenzie exercisesThe 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 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored mat exercise programThe 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. | Other | Tailored mat exercise program |
| McKenzie exercisesThe 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. | Other | McKenzie exercises |
Primary outcome
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.
Roland-Morris disability questionnaire (RMDQ)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 37936147Fonseca 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.
- BackgroundBais 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.
- Background: PubMed 35507483Chiarotto 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.
- BackgroundRavindran 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.
- BackgroundBelli 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-.
- Background: PubMed 33591367Stevans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hina gul, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored mat exercise program and McKenzie exercises in people with Back Pain, Low, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue Scale (time frame: 10th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750380, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.