- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06387927
Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain
April 25, 2024 updated by: Mohamed Ababa, Ahram Canadian University
The Effectiveness of Home-based Exercise Programs Versus Supervised Conventional Core Stability Exercises in Treatment of Chronic Mechanical, Non-specific Low Back Pain Patients With Controlled Hypertension
Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt.
They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program.
In both groups' patients had evaluations before and after their six-week course of therapy.
Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
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Giza, Egypt, 3387722
- Faculty of Physical Therapy
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-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- hypertensive patient
- patient with chronic back pain
- The patients aged 30 to 50 years
Exclusion Criteria:
- Patients with vertebral fractures
- patient with surgical spinal fixation
- patient with rheumatic disorders
- patient with systemic diseases
- patient with multiple sclerosis.
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A (control) received supervised conventional core stability exercise program Study
Group A (control) received supervised conventional core stability exercise program
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supervised conventional core stability exercise
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Experimental: group B received a home-based exercise program
Group B received a home-based exercise program.
|
Patients in group B were taught the core stability exercise in the first visit they received Arabic printed booklet for exercise description repetitions with diagrams in addition to Arabic illustration videos, they received a weekly telephone call to ensure their compliance to the exercise & motivation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of pain
Time Frame: up to 4 weeks
|
Pain was assessed using the visual analog scale
|
up to 4 weeks
|
Assessment of lumbar flexion range of motion
Time Frame: up to 4 weeks
|
performed by modified modified schober test
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up to 4 weeks
|
Assessment of functional disability
Time Frame: up to 4 weeks
|
performed by Oswestry disability questionnaire version 2.0
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 2, 2023
Primary Completion (Actual)
February 2, 2024
Study Completion (Actual)
February 20, 2024
Study Registration Dates
First Submitted
April 19, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-NEUR-10/2023-520
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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