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CompletedNCT03902132Updated May 6, 2019

Core Muscle Stability on Low Back Pain and Quality of Life in Post- Menopausal Women

An interventional study of Core Stability exercises group and Traditional low back physical therapy group in Backache, Low, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Backache, Low

Keywords

  • Backache
  • Core Stability exercises
  • Post menopausal
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 40-60 years
  • Post menopausal women
  • Having low back pain (NPRS >2)

Exclusion criteria

Exclusion Criteria:

  • Participants with physical or mental illness making them unable to participate in the study
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Core Stability exercises group

    Core Stability exercises

    Other: Core Stability exercises group

  • Active comparator
    Traditional low back physical therapy group

    Traditional low back physical therapy management

    Other: Traditional low back physical therapy group

Interventions

  • OtherCore Stability exercises group

    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).

  • OtherTraditional low back physical therapy group

    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)

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What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

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Study locations

1 site
  • Imran Amjad
    Islamabad, 46000, Pakistan
08

References and documents

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 24639852 ↗
  • Kamper 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 25694111 ↗
  • Kozinoga 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 26528111 ↗
  • Park 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 20811756 ↗
  • Dalal PK, Agarwal M. Postmenopausal syndrome. Indian J Psychiatry. 2015 Jul;57(Suppl 2):S222-32. doi: 10.4103/0019-5545.161483. PubMed 26330639 ↗
  • Moratalla-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 27085340 ↗
  • Akuthota 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 18296944 ↗
  • Thompson 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 12821592 ↗
  • Akuthota 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03902132
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Apr 3, 2019
Start date
Mar 1, 2018
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
May 6, 2019

Study contacts

Irum Yaqoob, MSNMPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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