Backache, LowNCT03902132
Core Muscle Stability on Low Back Pain and Quality of Life in Post- Menopausal Women
A study testing Core Stability exercises group and Traditional low back physical therapy group in people with Backache, Low, run by Riphah International University at 1 site in Pakistan.
Trial summary
Low back pain, postural dysfunction, loss of balance control and stability are musculoskeletal changes that occur over life span due to aging process and are inevitable. Core stability exercises are an effective means to counteract these changes.The study was executed with initially n=35 subjects selected as per… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Backache, Low
- What is being tested?
- Core Stability exercises group and Traditional low back physical therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2018to 1 Jun 2018
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40-60 years
- Post menopausal women
- Having low back pain (NPRS >2)
Who cannot join
- Participants with physical or mental illness making them unable to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Core Stability Exercises on Lower Back Pain and Quality of Life in Post-menopausal Women.
Low back pain, postural dysfunction, loss of balance control and stability are musculoskeletal changes that occur over life span due to aging process and are inevitable. Core stability exercises are an effective means to counteract these changes.The study was executed with initially n=35 subjects selected as per proposal, but only n=24 subjects completed the study with n=14 in experimental group and n=10 in control group. Experimental group received core stability exercises and control group received conventional physical therapy treatment for 12 weeks. Baseline assessment was done, then at 6 week and again at end of intervention.Following outcome measures were used in study Numeric pain rating scale (NPRS), Utain quality of life (UQOL), Oswestry disability index (ODI), manual muscle testing (MMT) flexion and extension. Data was analysed using Statistical package for social sciences SPSS- 21.
Read the detailed description
About total of 80% of population once in their life have gone through Low back pain that cause significant loss of productive working hours along with disability. People suffering from chronic low back pain and impaired function, often experience anxiety, depression, as well as effects on work and social life. Low back pain largely effects the women population, aged 45-60 years, accounting for distress on a social as well as economic level.
Age predicted incidence of low back pain (LBP) was also found to be higher in post-menopausal women. (90% between 40 and 60, mean age 50.1 years). Decline in psychological and cognitive function along with other health related conditions like heart disease, mood swings, risk of cancer are of particular importance in post-menopausal women affecting their quality of life.
The hormonal changes occurring in women during and after menopause, may also have an impact on health-related quality of life (HRQoL) particularly at the physical, psychological, and sexual spheres. Physical therapy remains the most advanced conservative option for the treatment of LBP Core stability or core strengthening exercises are increasingly becoming an important element of the sports world of therapeutics as it provides distal mobility with proximal stability(9). Core stability and strengthening exercises are supported strongly by theoretical principles for the treatment of spinal disorders that helps in decreasing pain and improving function in people suffering from LBP.
Core strengthening has attracted limited research attention so far yet it has been promoted as a mode of rehabilitation, for performance enhancement and as preventive measure of injuries related to the musculoskeletal and lumbar spine. The significance of core stability exercises in postmenopausal women with backache has been overlooked so far. The proposed study focused on Core stability exercises in Postmenopausal woman with Lower back pain to investigate the effects of core strength training on lower back pain, disability, strength and the quality of life in postmenopausal woman.
- Conditions
- Backache, Low
- Being tested
- Core Stability exercises group, Traditional low back physical therapy group
- Keywords
- Backache, Core Stability exercises, Post menopausal
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stability exercises groupOther
Core Stability Exercises were given in addition to the traditional physical therapy treatment as given to the control group. It included moist heat pack (10mins), Transcutaneous Electrical Nerve Stimulation (10 min), and strengthening regimen (2 sets with 15 isometric repetitions each).
Traditional low back physical therapy groupOther
The control group was given traditional low backache physical therapy management such as moist heat pack, TENS, and strengthening regimen (2 sets with 15 isometric repetitions each)
| Study group | Role | What they receive |
|---|---|---|
| Core Stability exercises group | Experimental | Core Stability exercises Receives: Other: Core Stability exercises group |
| Traditional low back physical therapy group | Active comparator | Traditional low back physical therapy management Receives: Other: Traditional low back physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
Changes from the Baseline, NPRS was used to measure the patient's pain intensity and divided from 0-11 into 11 divisions. 0 means absence of pain. 1 to 3 demonstrates mild degree of pain. 4 to 6 moderate level of pain and 7 to 10 means severe degree of pain. Patients were directed to select a number that best described the pain at the moment.
Measured: The score were recorded at baseline, at the (6th week) and at 12th visit (12th week) to determine the reduction or aggravation of pain followed by treatment in both control and experimental groups.
Utian Quality of Life (UQOL):
Changes from the Baseline, Quality of life (QOL), a statistical outcome variable must be measured in a regulatory trial research in a clinical care settings. Utian QOL scale (UQOL) is dynamically based on sensitivity of well-being as distinct from menopausal symptoms.
Measured: The score were recorded at baseline, at the 6th visit (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
Secondary outcomes (2)
Oswestry disability Index (ODI):
Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.
Measured: The score were recorded at baseline, at 6th session the (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
Manual Muscle Testing (MMT)
Changes from the Baseline, MMT of flexors and extensors. It consists of 0- 5 grades. 0 indicates no visible or palpable contraction, 1 indicates Visible or palpable contraction with no motion, 2 indicates full range of motion (ROM) with gravity eliminated, 3 full range of motion anti gravity, 4 shows Full ROM against gravity, moderate resistance, 5 indicates Full ROM against gravity, maximal resistance.
Measured: The score were recorded at baseline, at the (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Backache, 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irum Yaqoob, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902132
- Sponsor's protocol ID
- RiphahIU Sumaira Kanwal
- Status last verified
- May 2019
- First submitted
- 20 Mar 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed R, Shakil-Ur-Rehman S, Sibtain F. Comparison between Specific Lumber Mobilization and Core-Stability Exercises with Core-Stability Exercises Alone in Mechanical low back pain. Pak J Med Sci. 2014 Jan;30(1):157-60. doi: 10.12669/pjms.301.4424.
PubMed 24639852Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
PubMed 25694111Kozinoga M, Majchrzycki M, Piotrowska S. Low back pain in women before and after menopause. Prz Menopauzalny. 2015 Sep;14(3):203-7. doi: 10.5114/pm.2015.54347. Epub 2015 Sep 30.
PubMed 26528111Park JJ, Shin J, Youn Y, Champagne C, Jin E, Hong S, Jung K, Lee S, Yeom S. Bone mineral density, body mass index, postmenopausal period and outcomes of low back pain treatment in Korean postmenopausal women. Eur Spine J. 2010 Nov;19(11):1942-7. doi: 10.1007/s00586-010-1559-7. Epub 2010 Sep 1.
PubMed 20811756Dalal PK, Agarwal M. Postmenopausal syndrome. Indian J Psychiatry. 2015 Jul;57(Suppl 2):S222-32. doi: 10.4103/0019-5545.161483.
PubMed 26330639Moratalla-Cecilia N, Soriano-Maldonado A, Ruiz-Cabello P, Fernandez MM, Gregorio-Arenas E, Aranda P, Aparicio VA. Association of physical fitness with health-related quality of life in early postmenopause. Qual Life Res. 2016 Oct;25(10):2675-2681. doi: 10.1007/s11136-016-1294-6. Epub 2016 Apr 16.
PubMed 27085340Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
PubMed 18296944Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
PubMed 12821592Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.
PubMed 15034861
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Exercises on Lower Back Pain and Quality of Life in Post-menopausal Women.
- ClinicalTrials.gov ID
- NCT03902132
- Acronym / sponsor ID
- RiphahIU Sumaira Kanwal
- Conditions
- Backache, Low
- Keywords
- Backache, Core Stability exercises, Post menopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 3 Apr 2019 (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.
Low back pain, postural dysfunction, loss of balance control and stability are musculoskeletal changes that occur over life span due to aging process and are inevitable. Core stability exercises are an effective means to counteract these changes.The study was executed with initially n=35 subjects selected as per proposal, but only n=24 subjects completed the study with n=14 in experimental group and n=10 in control group. Experimental group received core stability exercises and control group received conventional physical therapy treatment for 12 weeks. Baseline assessment was done, then at 6 week and again at end of intervention.Following outcome measures were used in study Numeric pain rating scale (NPRS), Utain quality of life (UQOL), Oswestry disability index (ODI), manual muscle testing (MMT) flexion and extension. Data was analysed using Statistical package for social sciences SPSS- 21.
Detailed description
About total of 80% of population once in their life have gone through Low back pain that cause significant loss of productive working hours along with disability. People suffering from chronic low back pain and impaired function, often experience anxiety, depression, as well as effects on work and social life. Low back pain largely effects the women population, aged 45-60 years, accounting for distress on a social as well as economic level.
Age predicted incidence of low back pain (LBP) was also found to be higher in post-menopausal women. (90% between 40 and 60, mean age 50.1 years). Decline in psychological and cognitive function along with other health related conditions like heart disease, mood swings, risk of cancer are of particular importance in post-menopausal women affecting their quality of life.
The hormonal changes occurring in women during and after menopause, may also have an impact on health-related quality of life (HRQoL) particularly at the physical, psychological, and sexual spheres. Physical therapy remains the most advanced conservative option for the treatment of LBP Core stability or core strengthening exercises are increasingly becoming an important element of the sports world of therapeutics as it provides distal mobility with proximal stability(9). Core stability and strengthening exercises are supported strongly by theoretical principles for the treatment of spinal disorders that helps in decreasing pain and improving function in people suffering from LBP.
Core strengthening has attracted limited research attention so far yet it has been promoted as a mode of rehabilitation, for performance enhancement and as preventive measure of injuries related to the musculoskeletal and lumbar spine. The significance of core stability exercises in postmenopausal women with backache has been overlooked so far. The proposed study focused on Core stability exercises in Postmenopausal woman with Lower back pain to investigate the effects of core strength training on lower back pain, disability, strength and the quality of life in postmenopausal woman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Core Stability exercises group | Experimental | Other: Core Stability exercises groupCore Stability exercises |
| Traditional low back physical therapy group | Active comparator | Other: Traditional low back physical therapy groupTraditional low back physical therapy management |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 40-60 years
- Post menopausal women
- Having low back pain (NPRS >2)
Key exclusion criteria (1 listed)
- Participants with physical or mental illness making them unable to participate in the study
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 |
|---|---|---|
| Core Stability exercises groupCore Stability Exercises were given in addition to the traditional physical therapy treatment as given to the control group. It included moist heat pack (10mins), Transcutaneous Electrical Nerve Stimulation (10 min), and strengthening regimen (2 sets with 15 isometric repetitions each). | Other | Core Stability exercises group |
| Traditional low back physical therapy groupThe control group was given traditional low backache physical therapy management such as moist heat pack, TENS, and strengthening regimen (2 sets with 15 isometric repetitions each) | Other | Traditional low back physical therapy group |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: The score were recorded at baseline, at the (6th week) and at 12th visit (12th week) to determine the reduction or aggravation of pain followed by treatment in both control and experimental groups.
Changes from the Baseline, NPRS was used to measure the patient's pain intensity and divided from 0-11 into 11 divisions. 0 means absence of pain. 1 to 3 demonstrates mild degree of pain. 4 to 6 moderate level of pain and 7 to 10 means severe degree of pain. Patients were directed to select a number that best described the pain at the moment.
Utian Quality of Life (UQOL):
Time frame: The score were recorded at baseline, at the 6th visit (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
Changes from the Baseline, Quality of life (QOL), a statistical outcome variable must be measured in a regulatory trial research in a clinical care settings. Utian QOL scale (UQOL) is dynamically based on sensitivity of well-being as distinct from menopausal symptoms.
2 secondary outcomes
Oswestry disability Index (ODI):
Time frame: The score were recorded at baseline, at 6th session the (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
Manual Muscle Testing (MMT)
Time frame: The score were recorded at baseline, at the (6th week) and at 12th visit (12th week) followed by treatment in both control and experimental groups.
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 6 May 2019.
- Background: PubMed 24639852Ahmed R, Shakil-Ur-Rehman S, Sibtain F. Comparison between Specific Lumber Mobilization and Core-Stability Exercises with Core-Stability Exercises Alone in Mechanical low back pain. Pak J Med Sci. 2014 Jan;30(1):157-60. doi: 10.12669/pjms.301.4424.
- Background: PubMed 25694111Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
- Background: PubMed 26528111Kozinoga M, Majchrzycki M, Piotrowska S. Low back pain in women before and after menopause. Prz Menopauzalny. 2015 Sep;14(3):203-7. doi: 10.5114/pm.2015.54347. Epub 2015 Sep 30.
- Background: PubMed 20811756Park JJ, Shin J, Youn Y, Champagne C, Jin E, Hong S, Jung K, Lee S, Yeom S. Bone mineral density, body mass index, postmenopausal period and outcomes of low back pain treatment in Korean postmenopausal women. Eur Spine J. 2010 Nov;19(11):1942-7. doi: 10.1007/s00586-010-1559-7. Epub 2010 Sep 1.
- Background: PubMed 26330639Dalal PK, Agarwal M. Postmenopausal syndrome. Indian J Psychiatry. 2015 Jul;57(Suppl 2):S222-32. doi: 10.4103/0019-5545.161483.
- Background: PubMed 27085340Moratalla-Cecilia N, Soriano-Maldonado A, Ruiz-Cabello P, Fernandez MM, Gregorio-Arenas E, Aranda P, Aparicio VA. Association of physical fitness with health-related quality of life in early postmenopause. Qual Life Res. 2016 Oct;25(10):2675-2681. doi: 10.1007/s11136-016-1294-6. Epub 2016 Apr 16.
- Background: PubMed 18296944Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
- Background: PubMed 12821592Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
- Background: PubMed 15034861Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.
- 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.
Irum Yaqoob, MSNMPT 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 Core Stability exercises group and Traditional low back physical therapy group in people with Backache, 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 3 inclusion and 1 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 6 May 2019. 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?
Numeric pain rating scale (NPRS) (time frame: The score were recorded at baseline, at the (6th week) and at 12th visit (12th week) to determine the reduction or aggravation of pain followed by treatment in both control and experimental groups.). The study lists 2 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 NCT03902132, which also lists 9 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 6 May 2019.