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

Primary Purpose

Backache, Low

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Core Stability exercises group
Traditional low back physical therapy group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Backache, Low focused on measuring Backache, Core Stability exercises, Post menopausal

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Imran Amjad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core Stability exercises group

Traditional low back physical therapy group

Arm Description

Core Stability exercises

Traditional low back physical therapy management

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 20, 2019
Last Updated
May 2, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03902132
Brief Title
Core Muscle Stability on Low Back Pain and Quality of Life in Post- Menopausal Women
Official Title
Effects of Core Stability Exercises on Lower Back Pain and Quality of Life in Post-menopausal Women.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Backache, Low
Keywords
Backache, Core Stability exercises, Post menopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core Stability exercises group
Arm Type
Experimental
Arm Description
Core Stability exercises
Arm Title
Traditional low back physical therapy group
Arm Type
Active Comparator
Arm Description
Traditional low back physical therapy management
Intervention Type
Other
Intervention Name(s)
Core Stability exercises group
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Traditional low back physical therapy group
Intervention Description
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 Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
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.
Title
Utian Quality of Life (UQOL):
Description
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 Outcome Measure Information:
Title
Oswestry disability Index (ODI):
Description
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.
Title
Manual Muscle Testing (MMT)
Description
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Post menopausal women
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irum Yaqoob, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imran Amjad
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24639852
Citation
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.
Results Reference
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PubMed Identifier
25694111
Citation
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.
Results Reference
background
PubMed Identifier
26528111
Citation
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.
Results Reference
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PubMed Identifier
20811756
Citation
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.
Results Reference
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PubMed Identifier
26330639
Citation
Dalal PK, Agarwal M. Postmenopausal syndrome. Indian J Psychiatry. 2015 Jul;57(Suppl 2):S222-32. doi: 10.4103/0019-5545.161483.
Results Reference
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PubMed Identifier
27085340
Citation
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.
Results Reference
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PubMed Identifier
18296944
Citation
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.
Results Reference
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PubMed Identifier
12821592
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Core Muscle Stability on Low Back Pain and Quality of Life in Post- Menopausal Women

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