- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552064
Effect of Lumbar Spine Correction Training on Postural Awareness and Stability in Patients With Low Back Pain
PURPOSE: to investigate The Efficacy of lumbar spine correction training on postural awareness and stability in patients with low back pain. Patients with low back pain demonstrate impairments in function and range of motion to deficits in patient's quality of life.
HYPOTHESES: It will be hypothesized that there will be no statically Effect of lumbar spine correction training on postural awareness and stability in patients with low back pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Their ages range from 25 to 45 years.
- Both sex
- Low back pain for more than 6 months.
- Normal body mass index (18.5 - 29 Kg/m2).
Exclusion Criteria:
- Patients with any other Neurological deficits, psychiatric disease lumbar myelopathy, Cognitive problems, vertebral fractures and previous history of spine or lumbar surgery.
- Clinical instability, recent trauma
- Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
- Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: lumbar spine correction training
|
The patients will be mainly trained with trunk control exercise inform of: the trunk muscle against gravity and a Swiss ball for training on an unstable surface.
Also the program will include Postural correction exercise inform of: Abdominal drawing-in breathing, upper body raising, bridge exercise, quadruped and spinal extension exercises will carried out
Therapeutic Ultrasound device with patient prone lying position paravertebral in posterior aspect of back, Transcutaneous Electrical Nerve Stimulation (TENS) in the prone position, the electrodes will be positioned on the patient's pain area with a frequency of 100Hz , Heat application: in the form of (hot packs) for 15 minutes on posterior aspect of back as the patient will be in prone lying position and Core strengthening exercises
|
|
Experimental: conventional treatment
|
Therapeutic Ultrasound device with patient prone lying position paravertebral in posterior aspect of back, Transcutaneous Electrical Nerve Stimulation (TENS) in the prone position, the electrodes will be positioned on the patient's pain area with a frequency of 100Hz , Heat application: in the form of (hot packs) for 15 minutes on posterior aspect of back as the patient will be in prone lying position and Core strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Low Back Pain Disability Questionnaire
Time Frame: four weeks
|
The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Each item consist of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability
|
four weeks
|
|
multidirectional reach test
Time Frame: four weeks
|
The Multi-directional reach test is an inexpensive, reliable, and valid tool for measuring the limits of stability as derived by reach in four directions.
Values obtained on relatively healthy older adults serve as norms for screening patient populations
|
four weeks
|
|
postural habits and awareness scale (PHAS)
Time Frame: four weeks
|
The Postural Habits and Awareness Scale (PHAS) is a 19-item, 5-point Likert scale developed to assess individuals' self-perceived postural habits and their conscious awareness of posture Scoring: The scale is scored from 1 (completely disagree) to 5 (completely agree), with 7 items being reverse-coded.
where higher scores indicate better postural habits and greater awareness.
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analogue scale (VAS)
Time Frame: four weeks
|
The visual analogue scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain
|
four weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- O6U.PT. REC/025/002017
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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