- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05047614
Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
Study Overview
Detailed Description
Chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. Chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. Low back pain represents a major social and economic problem. The prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in French healthcare workers. Low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. Moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. Low back pain has been associated with motor control dysfunction. Indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. An association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area.
This was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MAI HASSAN, Doctoral
- Phone Number: 01019461836
- Email: Mai.Hassan.ph@o6u.edu.eg
Study Contact Backup
- Name: Hossam Magdy, Doctoral
- Phone Number: 01112730605
- Email: Hosam.Magdy.PT@o6u.edu.eg
Study Locations
-
-
-
Giza, Egypt, 12511
- Recruiting
- October 6 University
-
Contact:
- Hossam Magdy, Doctoral
- Phone Number: 01112730605
- Email: Hosam.Magdy.PT@o6u.edu.eg
-
Contact:
- Mai Hassan, Doctoral
- Phone Number: o1019461836
- Email: Mai.Hassan.ph@o6u.edu.eg
-
Principal Investigator:
- Mai Hasssan, Doctoral
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with CMLBP referred from orthopedic surgeon with no radicular pain
- Their age is ranged between 35-55 years old (Martim etal.,2008)
- BMI 24-28 kg/m2
Exclusion Criteria:
- Patients who have a history of diabetic peripheral neuropathies
- Patients who have a history of sciatica
- Spinal or lower limb deformity or any pathology within the spine.
- Patients who have neurological disorders
- Patients who have a history of previous lumbar surgery
- Patients who have visual problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study 1
Twelve patients in study group 1 receiving lumbar repositioning feedback training
|
Repositiong feedback training and biofeedback pressure training unit
|
|
Experimental: Study 2
Twelve patients in study group 2 receiving transverses abdominis training
|
Repositiong feedback training and biofeedback pressure training unit
|
|
Experimental: Study 3
Twelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training
|
Repositiong feedback training and biofeedback pressure training unit
|
|
Experimental: Control
Twelve patients in control group receiving conventional lumbar propriception physical therapy program .
|
Repositiong feedback training and biofeedback pressure training unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure biofeedback unit
Time Frame: up to 45 days
|
Assessment of transversus abdominis activation
|
up to 45 days
|
|
feedback laser tracker
Time Frame: up to 45 days
|
Assessment of lumbar repositioning error
|
up to 45 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 153145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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