- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05953922
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wafaa A. Salama Ashour, Bachelor's
- Phone Number: 01008983388
- Email: pt.w.ahmedashour@gmail.com
Study Locations
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Cairo, Egypt
- Recruiting
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: treatment group
The treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks.
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core stability exercises and transcutaneous electrical nerve stimulation for four week three session per week
Other Names:
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No Intervention: control group
The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life for each participants
Time Frame: baseline
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We will use the Arabic version of world health organization's quality of life (Arabic_WHOQOL-BREF) questionnaire and higher score means better outcome
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baseline
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pain levels for each participants
Time Frame: baseline
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visual analogue scale will be used to assess the level of pain and higher score means worse outcome
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baseline
|
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pressure lumber biofeedback for each participants
Time Frame: baseline
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pressure lumber biofeedback for asses transverse abdominis contraction
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: EMAN M. FAYEZ, Professor, physical therapy for neuromuscular disorder and its surgery
- Study Chair: Hossam M. Alsaid, Lecturer, physical therapy for neuromuscular disorder and its surgery
- Study Chair: MARIHAN Z. Aziz, Lecturer, Physical Therapy for Musculoskeletal Disorders and its Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- non specific low back pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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