Back to resultsEffect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
Primary Purpose
Mechanical Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional treatment
Open chain segmental control
Closed chain segmental control
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring Mechanical LBP, Cross Sectional Area, Multifidus muscle
Eligibility Criteria
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.
Sites / Locations
- Faculty of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Control
Intervention 1
Intervention 2
Arm Description
The participants will receive conventional treatment in the form of TENS and Ultrasound.
The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
Outcomes
Primary Outcome Measures
Cross sectional area of multifidus muscle
Cross sectional area of multifidus muscle
Pain intensity
Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
Secondary Outcome Measures
ROM of lumbar spine
Measuring ROM of lumbar spine
Functional ability of lumbar spine
Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06009263
Brief Title
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
Official Title
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2023 (Actual)
Primary Completion Date
August 13, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
Mechanical LBP, Cross Sectional Area, Multifidus muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group will receive ultrasound and TENS as conventional treatment
Masking
Participant
Masking Description
Group will receive open chain segmental control exercises versus closed chain segmental control exercises
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
The participants will receive conventional treatment in the form of TENS and Ultrasound.
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Intervention Type
Other
Intervention Name(s)
Open chain segmental control
Intervention Description
Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Intervention Type
Other
Intervention Name(s)
Closed chain segmental control
Intervention Description
Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Primary Outcome Measure Information:
Title
Cross sectional area of multifidus muscle
Description
Cross sectional area of multifidus muscle
Time Frame
Pre and Post measurement (12 weeks)
Title
Pain intensity
Description
Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)
Time Frame
Pre and Post measurement (12 weeks)
Secondary Outcome Measure Information:
Title
ROM of lumbar spine
Description
Measuring ROM of lumbar spine
Time Frame
Pre and Post measurement (12 weeks)
Title
Functional ability of lumbar spine
Description
Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)
Time Frame
Pre and Post measurement (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haytham M Elhafez, PhD
Phone
+201001909630
Email
elhafez@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haytham M Elhafez, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
State/Province
Dokki
ZIP/Postal Code
12612
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haytham M Elhafez
Phone
+201001909630
Email
elhafez@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mona E Hassan, Msc
First Name & Middle Initial & Last Name & Degree
Hend H Ahmed, PhD
First Name & Middle Initial & Last Name & Degree
Ghada A Abdallah, PhD
12. IPD Sharing Statement
Learn more about this trial
Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
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