- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005948
Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery
January 3, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
Investigation of the Effect of Dynamic Neuromuscular Stabilization on Pain, Functionality and Kinesiophobia in Individuals Undergoing Lumbar Disc Herniation Surgery
The aim of the study is to investigate the effects of dynamic neuromuscular stabilization exercises on pain, functionality and fear in individuals who have undergone lumbar disc herniation surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research was planned as a randomized controlled trial, which is a quantitative study.
Participants will be divided into 2 groups as control and exercise groups by simple randomization method.
The individuals in the control group of the study will not be given any exercise program after surgery.
A home exercise program created with Dynamic Neuromuscular Stabilization exercises after surgery will be applied to the individuals in the intervention group.
Data collection will be carried out through an online survey.
The scales and forms to be used before and after the treatment are respectively: 1. Oswestry Low Back Pain Disability Questionnaire 2. International Physical Activity Questionnaire (Short Form) 3. Questionnaire for Fear of Daily Living Activities The questionnaires will be uploaded to the Google Forms database and the participants will be accessed via e-mail or mobile phone applications. .
They will be asked to fill out the questionnaires before starting the post-surgical exercise program and the exercise program will be explained practically before discharge.
The exercises will be planned 3 times a week and for 8 weeks.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Uskudar University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be between 30 and 50 years old.
- Having undergone lumbar disc hernia surgery.
- Having access to a computer/tablet/phone and internet.
Exclusion Criteria:
- Having cognitive, mental or psychological problems.
- Having a visual or hearing impairment.
- Having a physical condition that causes significant loss of function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Active Comparator: control group
No exercise will be given after surgery
|
No intervention will be made.
|
|
Experimental: exercise group
Dynamic neuromuscular stabilization exercises will be performed for 8 weeks after surgery.
|
The dynamic neuromuscular stabilization group will receive developmental postures based on developmental kinesiology.
It will involve a supine 3month Position, side-lying Position, Quadruped, oblique sitting, bear position, squat Position.
Each position will be performed for 30-60 s for five reps, active exercise 5-10 reps under supervision for two days/week, and unsupervised for 3 days/week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Oswestry Disability Index
Time Frame: 10 weeks
|
The questionnaire includes ten topics related to pain severity, weight lifting, self-care, walking, sitting, sexual function, standing, social life, sleep quality, and ability to travel.
expression follows.
The patient then checks for the expression that most closely resembles his condition.
Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least disability, and the last statement being scored as 5 indicating the most severe disability.
The scores of all answered questions are added up, then multiplied by two to get the index (range 0 to 100).
Zero equals no obstacle and 100 is the maximum possible obstacle.
|
10 weeks
|
|
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: 10 weeks
|
It consists of 7 questions.
The questions provide information about time spent walking, time spent in moderate and vigorous activities, and time spent sitting.
Calculation of the short form's total score includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity.
The energy required for activities is calculated with the metabolic equivalent (MET) -minute score.
Standard MET values have been established for these activities.
These are; Sitting 1.5 MET, Walking 3.3 MET, Moderate-intensity physical activity 4.0 MET, Vigorous physical activity 8.0 MET.
Daily and weekly physical activity using these values level is calculated.
|
10 weeks
|
|
Fear of Daily Living Activities Questionnaire
Time Frame: 10 weeks
|
In the questionnaire consisting of 10 questions, the participant is asked to score each question between 0 and 100.
No fear of the activity is set to 0 and excessive fear of the activity is 100.
In addition, the participants are asked to add 2 different activities that are not included in the survey but cause fear.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Büşra ARISÜT, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Venkatesan P, K S, Kishen TJ, Janardhan S, Kumar Cr S. Comparison of yoga and dynamic neuromuscular stabilization exercise in chronic low back pain on magnetic resonance imaging of lumbar multifidus- protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100937. doi: 10.1016/j.conctc.2022.100937. eCollection 2022 Aug.
- Baerga-Varela L, Abreu Ramos AM. Core strengthening exercises for low back pain. Bol Asoc Med P R. 2006 Jan-Mar;98(1):56-61.
- Butowicz CM, Acasio JC, Silfies SP, Nussbaum MA, Hendershot BD. Chronic low back pain influences trunk neuromuscular control during unstable sitting among persons with lower-limb loss. Gait Posture. 2019 Oct;74:236-241. doi: 10.1016/j.gaitpost.2019.09.019. Epub 2019 Sep 18.
- Lariviere C, Gagnon DH, Henry SM, Preuss R, Dumas JP. The Effects of an 8-Week Stabilization Exercise Program on Lumbar Multifidus Muscle Thickness and Activation as Measured With Ultrasound Imaging in Patients With Low Back Pain: An Exploratory Study. PM R. 2018 May;10(5):483-493. doi: 10.1016/j.pmrj.2017.10.005. Epub 2017 Oct 31.
- Kararti C, Ozsoy I, Ozyurt F, Basat HC, Ozsoy G, Ozudogru A. The effects of dynamic neuromuscular stabilization approach on clinical outcomes in older patients with chronic nonspecific low back pain: a randomized, controlled clinical trial. Somatosens Mot Res. 2023 Sep;40(3):116-125. doi: 10.1080/08990220.2023.2191705. Epub 2023 Mar 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
November 28, 2023
Study Completion (Actual)
December 6, 2023
Study Registration Dates
First Submitted
August 15, 2023
First Submitted That Met QC Criteria
August 21, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 3, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar75
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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