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Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain

Primary Purpose

Non Specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
core stability exersises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Specific Low Back Pain

Eligibility Criteria

22 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: gender is women age ranges from 22 to45 years old chronic non specific low back pain for at least 3 month pain score will between 3 to 6 on visual analogue scale Exclusion Criteria: Any deformity of the spine Red flags including serious pathology Systemic or inflammatory disease sever osteoporosis history of tumor or cancer spine infection history of spine or pelvis surgery or fracture cauda equina syndrome progressive neurological deficit severe instability sever cardio vascular or metabolic disease history of psychological disease anatomical and congenital disturbance continuous pain more than 8 on (visual analogue scale)

Sites / Locations

  • Faculty of Physical Therapy, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

treatment group

control group

Arm Description

The treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks.

The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks.

Outcomes

Primary Outcome Measures

quality of life for each participants
We will use the Arabic version of world health organization's quality of life (Arabic_WHOQOL-BREF) questionnaire and higher score means better outcome
pain levels for each participants
visual analogue scale will be used to assess the level of pain and higher score means worse outcome
pressure lumber biofeedback for each participants
pressure lumber biofeedback for asses transverse abdominis contraction

Secondary Outcome Measures

Full Information

First Posted
May 7, 2023
Last Updated
July 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05953922
Brief Title
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
Official Title
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain.
Detailed Description
The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain This study is delimited to the following aspects: Fifty, patients of only females with chronic non specific low back pain more than 3 months. The age will range from 22 to 45 years. The treatment will conduct to three session per week for four weeks . The selected patients will assigned randomly to two equal groups: 1- Group1 (intervention), will do the selected treatment that include electrical stimulation in addition to Core stability exercises program. 2- Group2(control), will do the conventional treatment only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
The treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks.
Intervention Type
Other
Intervention Name(s)
core stability exersises
Other Intervention Name(s)
transcutaneous electrical nerve stimulation
Intervention Description
core stability exercises and transcutaneous electrical nerve stimulation for four week three session per week
Primary Outcome Measure Information:
Title
quality of life for each participants
Description
We will use the Arabic version of world health organization's quality of life (Arabic_WHOQOL-BREF) questionnaire and higher score means better outcome
Time Frame
baseline
Title
pain levels for each participants
Description
visual analogue scale will be used to assess the level of pain and higher score means worse outcome
Time Frame
baseline
Title
pressure lumber biofeedback for each participants
Description
pressure lumber biofeedback for asses transverse abdominis contraction
Time Frame
baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gender is women age ranges from 22 to45 years old chronic non specific low back pain for at least 3 month pain score will between 3 to 6 on visual analogue scale Exclusion Criteria: Any deformity of the spine Red flags including serious pathology Systemic or inflammatory disease sever osteoporosis history of tumor or cancer spine infection history of spine or pelvis surgery or fracture cauda equina syndrome progressive neurological deficit severe instability sever cardio vascular or metabolic disease history of psychological disease anatomical and congenital disturbance continuous pain more than 8 on (visual analogue scale)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa A. Salama Ashour, Bachelor's
Phone
01008983388
Email
pt.w.ahmedashour@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMAN M. FAYEZ, Professor
Organizational Affiliation
Physical Therapy for Neuromuscular Disorder and Its Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hossam M. Alsaid, Lecturer
Organizational Affiliation
Physical Therapy for Neuromuscular Disorder and Its Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MARIHAN Z. Aziz, Lecturer
Organizational Affiliation
Physical Therapy for Musculoskeletal Disorders and its Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain

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