- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337213
Effect of Knee Extensor Training on the Lumbar Spine
Knee Extensor-Focused Biomechanical Intervention for Pain, Posture, and Disability in Non-Specific Low Back Pain: A Randomized Controlled Trial
The goal of this clinical trial is to learn if knee extensor training with different protocols works to treat LBP in adults.. The main questions it aims to answer are:
What are the comparative effects of open and closed kinetic chain knee extensor strengthening exercises versus lumbar stabilization exercises on lumbar curvature, postural control, and disability in individuals with non-specific low back pain? 1.4.2. How does open kinetic chain knee extensor strengthening affect pain, functional capacity, and lumbar spine stability compared to closed kinetic chain exercises in individuals with non-specific low back pain? 1.4.3 What is the effect of open kinetic chain knee extensor strengthening on pain, functional capacity, and lumbar spine stability compared to conventional lumbar muscle exercises in individuals with non-specific low back pain? 1.4.4 What is the effect of closed kinetic chain knee extensor strengthening on pain, functional capacity, and lumbar spine stability compared to conventional lumbar muscle exercises in individuals with non-specific low back pain? 1.4.5 What is the effect of open kinetic chain knee extensor strengthening on pain, functional capacity, and lumbar spine stability in individuals with non-specific low back pain? 1.4.6 What is the effect of close kinetic chain knee extensor strengthening on pain, functional capacity, and lumbar spine stability in individuals with non-specific low back pain? 1.4.7 What is the effect of conventional lumbar extensor strengthening on pain, functional capacity, and lumbar spine stability in individuals with non-specific low back pain Researchers will compare three different exercise protocols to a control group (will not receive exercise) to see if knee extensor training has an effect on problems associated with LBP.
Participants will:
- Exercise three times per week for 8 weeks
- Be assessed before, 4 weeks after, and 8 weeks after intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lamiaa K Elsayyad, Assistant professor
- Phone Number: +201095366120
- Email: dr.elsayyadlamiaa@gmail.com
Study Contact Backup
- Name: Hatem H Allam, Assistant professor
- Phone Number: +966543321736
- Email: hatem.lamiaa@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
I. Males aged 40 to 60 years, II. nonsmokers, III. with normal body mass index IV. of Saudi nationality, V. office workers, VI. suffering from chronic NLBP for 12 weeks or more with a moderate disability according to the Oswestry Disability Index (score of 21 - 40%) moderate activity level according to the Arabic version of the International Physical Activity Questionnaire short form .
Exclusion Criteria:
I. Previous spinal surgery, fracture, deformity, or disease. II. Neurological deficit and Lower limb deformity or fracture, or disease. III. Mental or psychological illness. The Arabic version of the Self-Reporting Questionnaire (SRQ-20) developed by the World Health Organization (WHO) to screen for common mental disorders such as depression and anxiety, uses a cut-off score to distinguish between individuals with and without significant psychological distress. A score of 7 or below is generally considered "normal", indicating no significant psychological distress (Al-Subaie et al., 1998).
IV. Systematic chronic illnesses such as hypertension, cardiac and respiratory disorders, and diabetes mellitus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
lumbar strengthening
|
strengthening exercise to lumbar extensors
|
|
Experimental: Treatment Group I
lumbar strengthening exercise and knee CKC exercise
|
knee extensor OKC exercise added to the lumbar strengthening exercise
|
|
Experimental: Treatment Group II
lumbar strengthening exercise and knee CKC exercise
|
knee extensor CKC exercise added to the lumbar strengthening exercise
|
|
Experimental: Treatment Group III
lumbar strengthening exercise and knee OKC and CKC exercise
|
knee extensor OKC and CKC exercise added to the lumbar strengthening exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change in the Lumbar lordosis Cobb angle in degrees measured by X-ray
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change of LBP intensity from the baseline measured by Numeric Pain Rating Scale
Time Frame: 8 weeks
|
Minimum Value: 0, which represents "no pain".
Maximum Value: 10, which represents "worst imaginable pain," "worst possible pain," or "most intense pain imaginable Higher scores indicate a worse outcome
|
8 weeks
|
|
Mean change in the quality of Life score as measured by the Oswestry Disability Index
Time Frame: 8 weeks
|
Minimum Value: 0%, which represents the highest possible level of functioning and independence (no disability). Maximum Value: 100%, which represents the lowest possible level of functioning and total dependence |
8 weeks
|
|
Mean change in the muscle strength measured by the Hand-held dynamometer
Time Frame: 8 weeks
|
A higher score indicate improvement
|
8 weeks
|
|
Mean change in the posture control measured by the stare exursion test
Time Frame: 8 weeks
|
Higher scores mean a better outcome
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ABDULLAH F ALHUMAYANI, LUC Malaysia
Study record dates
Study Major Dates
Study Start (Estimated)
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
- LUC/RADMIN/SP/05/903
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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