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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05047614
Other study ID # 153145
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 19, 2020
Est. completion date August 15, 2022

Study information

Verified date September 2021
Source October 6 University
Contact MAI HASSAN, Doctoral
Phone 01019461836
Email Mai.Hassan.ph@o6u.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date August 15, 2022
Est. primary completion date May 2, 2022
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 45 Years
Eligibility 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 Design


Intervention

Device:
including sham
Repositiong feedback training and biofeedback pressure training unit

Locations

Country Name City State
Egypt October 6 university Giza

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure biofeedback unit Assessment of transversus abdominis activation up to 45 days
Primary feedback laser tracker Assessment of lumbar repositioning error up to 45 days
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