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Effects of Exercise in Lumbal Disc Herniation

Primary Purpose

Lumbar Disc Herniation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stabilization exercises
McKenzie exercises
Home exercises
Sponsored by
Firat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar Disc Herniation, McKnezie exercises, stabilization exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients between the ages of 18 to 65 Patients who have diagnosed with LDH Exclusion Criteria: Patients who were pregnant diagnosed with malignancy had changes of medical treatment in the last 3 months had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits had regular exercise habit (minimally three days in a week)

Sites / Locations

  • Songül Bağlan YentürRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stabilization exercises

McKenzie exercises

Home exercises

Arm Description

Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Outcomes

Primary Outcome Measures

Core muscle thickness
Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).

Secondary Outcome Measures

Visual Analog Scale
Pain Severity; It will be evaluated with a 10 cm Visual Analogue Scale (VAS). Patients are told what the numbers on the horizontal line mean, 0 is no pain, 10 is the most severe pain in life, and 5 is moderate pain, and they are asked to describe the severity of their pain on the scale.
Modified Oswerty Inquiry
Functional Disability Measurement; The evaluation will be made using the Turkish version of the Modified Oswestry Inquiry Form. Turkish validity and reliability were determined by Edibe Yakut et al. (2004) by In the evaluation of the Oswestry scale, scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points. Questions that the patient does not answer will not be evaluated. Evaluation is made on the basis of the questions answered. Patient score =(Patient score/Maximum possible score)*100

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
Firat University
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1. Study Identification

Unique Protocol Identification Number
NCT05927051
Brief Title
Effects of Exercise in Lumbal Disc Herniation
Official Title
Comparison of Different Exercise Types in Patients With Lumbal Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of the most important elements in low back pain rehabilitation.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.
Detailed Description
n general, low back pain is defined as pain that negatively affects comfort in the lower back and/or legs. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and lasting longer than 12 weeks as chronic low back pain. Depending on the low back pain of the people, the activity level decreases and therefore aerobic fitness is negatively affected. As a result of this negative impact, chronic conditions pose a risk in terms of cardiovascular disease and lead to a decrease in work capacity. Therefore, aerobic exercise is one of the most important elements in low back pain rehabilitation. In our country, training on regular exercise habits and waist protection methods is very low. Most patients do not apply to health institutions unless symptoms become severe.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage. Core stabilization and strengthening has been the subject of research in the 1980s. The purpose of these exercises is to increase trunk stability and aerobic capacity. It is used to find and maintain the neutral position, to reduce ligament, tendon and joint tension, to reduce the load on discs and facet joints, to increase functional stability in low back pain, disc herniation and post-operative rehabilitation of patients.The researchers' studies have shown that ultrasound imaging is reliable in measuring TrA thickness in both healthy subjects and low back patients. The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar Disc Herniation, McKnezie exercises, stabilization exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stabilization exercises
Arm Type
Experimental
Arm Description
Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Arm Title
McKenzie exercises
Arm Type
Experimental
Arm Description
McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Arm Title
Home exercises
Arm Type
Experimental
Arm Description
Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Stabilization exercises
Intervention Description
Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
McKenzie exercises
Intervention Description
McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Home exercises
Intervention Description
Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks
Primary Outcome Measure Information:
Title
Core muscle thickness
Description
Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain Severity; It will be evaluated with a 10 cm Visual Analogue Scale (VAS). Patients are told what the numbers on the horizontal line mean, 0 is no pain, 10 is the most severe pain in life, and 5 is moderate pain, and they are asked to describe the severity of their pain on the scale.
Time Frame
1 minute
Title
Modified Oswerty Inquiry
Description
Functional Disability Measurement; The evaluation will be made using the Turkish version of the Modified Oswestry Inquiry Form. Turkish validity and reliability were determined by Edibe Yakut et al. (2004) by In the evaluation of the Oswestry scale, scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points. Questions that the patient does not answer will not be evaluated. Evaluation is made on the basis of the questions answered. Patient score =(Patient score/Maximum possible score)*100
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 18 to 65 Patients who have diagnosed with LDH Exclusion Criteria: Patients who were pregnant diagnosed with malignancy had changes of medical treatment in the last 3 months had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits had regular exercise habit (minimally three days in a week)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songül Bağlan Yentür
Phone
+90 424 2370000
Email
sbyentur@firat.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Şahin Elbastı
Phone
+90 424 2370000
Email
msahin23@hotmail.com
Facility Information:
Facility Name
Songül Bağlan Yentür
City
Elazığ
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songül Bağlan Yentür

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/19026017/
Description
Optimizing performance by improving core stability and core strength
URL
http://pubmed.ncbi.nlm.nih.gov/16550447/
Description
Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care

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Effects of Exercise in Lumbal Disc Herniation

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