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Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain

Primary Purpose

Orthopedic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
including sham
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • October 6 universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Study 1

Study 2

Study 3

Control

Arm Description

Twelve patients in study group 1 receiving lumbar repositioning feedback training

Twelve patients in study group 2 receiving transverses abdominis training

Twelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training

Twelve patients in control group receiving conventional lumbar propriception physical therapy program .

Outcomes

Primary Outcome Measures

Pressure biofeedback unit
Assessment of transversus abdominis activation
feedback laser tracker
Assessment of lumbar repositioning error

Secondary Outcome Measures

Full Information

First Posted
July 22, 2020
Last Updated
September 13, 2021
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05047614
Brief Title
Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
Official Title
Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2020 (Actual)
Primary Completion Date
May 2, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 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
This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study 1
Arm Type
Experimental
Arm Description
Twelve patients in study group 1 receiving lumbar repositioning feedback training
Arm Title
Study 2
Arm Type
Experimental
Arm Description
Twelve patients in study group 2 receiving transverses abdominis training
Arm Title
Study 3
Arm Type
Experimental
Arm Description
Twelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training
Arm Title
Control
Arm Type
Experimental
Arm Description
Twelve patients in control group receiving conventional lumbar propriception physical therapy program .
Intervention Type
Device
Intervention Name(s)
including sham
Intervention Description
Repositiong feedback training and biofeedback pressure training unit
Primary Outcome Measure Information:
Title
Pressure biofeedback unit
Description
Assessment of transversus abdominis activation
Time Frame
up to 45 days
Title
feedback laser tracker
Description
Assessment of lumbar repositioning error
Time Frame
up to 45 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MAI HASSAN, Doctoral
Phone
01019461836
Email
Mai.Hassan.ph@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam Magdy, Doctoral
Phone
01112730605
Email
Hosam.Magdy.PT@o6u.edu.eg
Facility Information:
Facility Name
October 6 university
City
Giza
ZIP/Postal Code
12511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Hassan, Doctoral
Phone
o1019461836
Email
Mai.Hassan.ph@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Hossam Magdy, Doctoral
Phone
01112730605
Email
Hosam.Magdy.PT@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Mai Hasssan, Doctoral

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain

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