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

May 2, 2019 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 46000
        • Imran Amjad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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):
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (ACTUAL)

April 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiphahIU Sumaira Kanwal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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