- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05288946
Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain (NSLBP)
October 27, 2022 updated by: Al Shaymaa Shaaban Abd El Azeim, Cairo University
Effect of Segmental Control Program on Hamstring Peak Torque,Pain,Function and Range of Motion in Patients With Non-specific Low Back Pain
The purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain.
Study Overview
Status
Completed
Conditions
Detailed Description
Low back pain (LBP) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.The reported prevalence of LBP was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group.
Recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for LBP management.
The approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine.
Several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability.
But also other core muscles are involved.
so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain.
forty-five patients will be allocated to three groups.
first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment
Study Type
Interventional
Enrollment (Actual)
60
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, 11251
- Cairo University
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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
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patients had NS LBP Patients with age from 20 to 40 years for both genders.
- The lumbar region of back pain lasts for 4 weeks & more has not been diagnose as a specific disease or spinal abnormality.
- Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%).
- Shortening of hamstring.
- The study populations must be willing to participate in the study.
Exclusion Criteria:
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease.
- Psychiatric/mental deficit
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
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: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: local segmental control and closed kinetic chain
the patients will receive local segmental control and closed kinetic chain three times a week for four weeks
|
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then closed kinetic chain exercise in the form of Stand-up position on unstable surface, Closed chain lunge exercises, with the addition of hand weights, Bridge in prone position, Bridge in supine position, Lateral Bridge
the patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors
|
|
EXPERIMENTAL: local segmental control and open kinetic chain
the patients will receive local segmental control and open kinetic chain three times a week for four weeks
|
the patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then open kinetic chain in the form of Lower limb abduction, Knee extension in a supine position on a roller, Open chain exercise of the upper limb after co-contraction of transversus abdominis and multifidus.
|
|
ACTIVE_COMPARATOR: traditional therapy
the patients will receive traditional therapy three times a week for four week
|
the patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peak torque
Time Frame: up to four weeks
|
isokinetic will be used for measuring hamstring peak torque
|
up to four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to four weeks
|
visual analogue scale will be used for assessment of pain intensity
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up to four weeks
|
|
disability
Time Frame: up to four weeks
|
oswestry disability scale will be used for assessment of disability, Each patient was asked to answer by checking one box in each section for the statement which best applies to him.
Then the marks had been counted and divided by 50 or 45.score ranging from 0 (no pain or disability) to 50 (severe pain and disability) .
Then was multiplied by 100 for the percentage (score/ 50) x 100=% points.
A score of 0% to 20% is minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled and 81%-100%: complete disability.
|
up to four 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)
March 28, 2022
Primary Completion (ACTUAL)
May 15, 2022
Study Completion (ACTUAL)
May 15, 2022
Study Registration Dates
First Submitted
March 11, 2022
First Submitted That Met QC Criteria
March 11, 2022
First Posted (ACTUAL)
March 21, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 31, 2022
Last Update Submitted That Met QC Criteria
October 27, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.t.REC/012/002673
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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