- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927051
Effects of Exercise in Lumbal Disc Herniation
Comparison of Different Exercise Types in Patients With Lumbal Disc Herniation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Songül Bağlan Yentür
- Phone Number: +90 424 2370000
- Email: sbyentur@firat.edu.tr
Study Contact Backup
- Name: Şahin Elbastı
- Phone Number: +90 424 2370000
- Email: msahin23@hotmail.com
Study Locations
-
-
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Elazığ, Turkey
- Recruiting
- Songül Bağlan Yentür
-
Contact:
- Songül Bağlan Yentür
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stabilization exercises
Core stability exercises will be performed three days in a week.
Treatment will continue an hour in per session for 8 weeks.
|
Core stability exercises will be performed three days in a week.
Treatment will continue an hour in per session for 8 weeks.
|
Experimental: McKenzie exercises
McKenzie 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.
|
Experimental: Home exercises
Home 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core muscle thickness
Time Frame: 2 minutes
|
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).
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: 1 minute
|
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.
|
1 minute
|
Modified Oswerty Inquiry
Time Frame: 2 minutes
|
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
|
2 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
- 13-20
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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