- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009263
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP (CSA)
May 15, 2026 updated by: Haytham M Elhafez, Cairo University
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain
To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber ROM.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on CSA of multifidus muscle.
- To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.
Study Type
Interventional
Enrollment (Estimated)
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 Contact
- Name: Haytham M Elhafez, PhD
- Phone Number: +201001909630
- Email: elhafez@yahoo.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt, 12612
- Recruiting
- Faculty of Physical Therapy
-
Contact:
- Haytham M Elhafez
- Phone Number: +201001909630
- Email: elhafez@yahoo.com
-
Sub-Investigator:
- Mona E Hassan, Msc
-
Sub-Investigator:
- Hend H Ahmed, PhD
-
Sub-Investigator:
- Ghada A Abdallah, PhD
-
-
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:
- Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.
- Participants with chronic low back pain lasting for more than 6 Months.
- A patient who can follow the command.
- A patient who can do exercise.
Exclusion Criteria:
- Low back pain patients with a history of severe neurological disease or orthopedic disease.
- History of Psychological Disorder.
- Unhealthy Patient.
- Pregnant women.
- Patient with a spinal tumor.
- History of any operation related to spine. Ex. Vertebral fracture or dislocation.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
The participants will receive conventional treatment in the form of TENS and Ultrasound.
|
Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
|
|
Experimental: Intervention 1
The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
|
Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
|
|
Experimental: Intervention 2
The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
|
Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cross sectional area of multifidus muscle
Time Frame: Pre and Post measurement (12 weeks)
|
Cross sectional area of multifidus muscle
|
Pre and Post measurement (12 weeks)
|
|
Pain intensity
Time Frame: Pre and Post measurement (12 weeks)
|
Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
|
Pre and Post measurement (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM of lumbar spine
Time Frame: Pre and Post measurement (12 weeks)
|
Measuring ROM of lumbar spine
|
Pre and Post measurement (12 weeks)
|
|
Functional ability of lumbar spine
Time Frame: Pre and Post measurement (12 weeks)
|
Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)
|
Pre and Post measurement (12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haytham M Elhafez, PhD, Cairo University
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 (Estimated)
June 13, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
August 13, 2023
First Submitted That Met QC Criteria
August 18, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/007/002763
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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