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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902132
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief 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.

Condition or disease Intervention/treatment Phase
Backache, Low Other: Core Stability exercises group Other: Traditional low back physical therapy group Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Masking Description: Single blinded
Primary Purpose: Treatment
Official Title: Effects of Core Stability Exercises on Lower Back Pain and Quality of Life in Post-menopausal Women.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Core Stability exercises group
Core Stability exercises
Other: Core 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).

Active Comparator: Traditional low back physical therapy group
Traditional low back physical therapy management
Other: Traditional 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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Post menopausal women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902132


Locations
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Pakistan
Imran Amjad
Islamabad, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Irum Yaqoob, MSNMPT Riphah International University
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT03902132    
Other Study ID Numbers: RiphahIU Sumaira Kanwal
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Backache
Core Stability exercises
Post menopausal
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations