- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06227767
Investigation of the Effect of Different Intensity Stabilization Exercises on Core Muscles
Investigation of the Effect of Different Intensity Stabilization Exercises on the Mechanical Properties of Core Muscles and Pain in Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with chronic low back pain who voluntarily participate in the study will be randomly divided into three groups. Physical and demographic information of the patients participating in the study will be collected. The number of patients who will participate in the study will be determined by the power analysis to be performed at the beginning of the study. Low back pain, disability index and pain sensitivity will be measured before treatment, after treatment and at the 12th week. Evaluation of core muscles with shear wave would be done at the beginning of treatment and at the 12th week. The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. Participants in the first group will be included in the exercise program planned in detail below, 2 days a week, and those in the second group 4 days a week. Patients included in the third group will be followed with a home exercise program. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
In the first phase of the exercise program, patients will be placed in the hook position and contraction of the transversus abdominis muscle and multifidus muscle will be taught. Then, patients will be asked to perform exercises that enable the activation of other muscles of the body while maintaining the contraction of the transversus abdominis and multifidus muscles, and these exercises will be progressed from easy to difficult exercises. During exercise, the activation of the patients' spinal stabilizer muscles will be kept under constant control and necessary warnings will be made in this regard. Exercises will initially start with 8-10 repetitions and gradually increase to 20 repetitions. All exercises will be performed in 2 sets and there will be 30 seconds of rest between sets.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: abuzer akbaş
- Phone Number: +90 5326442366
- Email: akbas.abuzer@gmail.com
Study Locations
-
-
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Adıyaman, Turkey, 02000
- Recruiting
- Adıyaman Training and Research Hospital
-
Contact:
- Esin akbaş
- Phone Number: +90 (0416) 216 10 15
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Gaziantep, Turkey, 27000
- Recruiting
- Hasan Kalyoncu University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic low back pain for at least 3 months.
- Not having participated in any physiotherapy or exercise program in the last month.
- Patients with informed consent
Exclusion Criteria:
- Malignancy
- Severe osteoporosis
- Arthritis
- Bone diseases
- Pregnancy
- Diabetics
- Lumbar or lower limb surgery
- Rheumatological and inflammatory problems.
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 |
---|---|
Active Comparator: exercise group twice a week
Spinal stabilization exercises determined by the authors will be applied 2 days a week for 40 minutes.
|
The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program.
The first group will be given an exercise program 2 days a week, the second group will be given an exercise program 4 days a week.
The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
|
Active Comparator: exercise group four times a week
Spinal stabilization exercises determined by the authors will be applied 4 days a week for 40 minutes.
|
The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program.
The first group will be given an exercise program 2 days a week, the second group will be given an exercise program 4 days a week.
The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
|
No Intervention: control group
Patients will be followed with a home exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of muscle elasticity with elastography
Time Frame: before treatment and 12nd (end of treatment) week of treatment
|
The mechanical properties of the transversus abdominis, one of the core muscles, will be evaluated by the shear wave elastography method.
|
before treatment and 12nd (end of treatment) week of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analog scale
Time Frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
The patients' low back pain severity will be evaluated with a visual analog scale.
Visual Analogue Scale: The left end of a 10 cm straight line represents no pain, and the right end represents unbearable pain.
The patient will be asked to mark the pain that feels on the Visual Analog Scale ruler during the test, and then this value will be measured and recorded with the help of a ruler
|
before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
oswestry disability index
Time Frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
In the survey, 10 pain questions evaluate the severity of pain personally, care, lifting, walking, sitting, standing, sleep, sexual life, social life, travel and the degree of change in pain.
Scoring is between 0-5 for each item and items that are not answered will be excluded from evaluation.
|
before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
evaluation of pain sensitivity
Time Frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
A pressure pain meter device (JTECH CommanderTM) will be used to evaluate pain sensitivity in patients with chronic low back pain.
The measurement will be made at 3 points and the points will be 2.5 cm apart vertically on the right and left lumbar paraspinal muscles.
|
before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: abuzer akbas, hasan kalyoncu university faculty of health science
Study record dates
Study Major Dates
Study Start (Actual)
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
- HasanKU_akbasa_001
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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