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Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery

Primary Purpose

Low Back Pain, Kinesiophobia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
control
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring pain, Neuromuscular Stabilization exercises, Kinesiophobia, surgical

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uskudar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

exercise group

Arm Description

No exercise will be given after surgery

Dynamic neuromuscular stabilization exercises will be performed for 8 weeks after surgery.

Outcomes

Primary Outcome Measures

The Oswestry Disability Index
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.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
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.
Fear of Daily Living Activities Questionnaire
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.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06005948
Brief Title
Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery
Official Title
Investigation of the Effect of Dynamic Neuromuscular Stabilization on Pain, Functionality and Kinesiophobia in Individuals Undergoing Lumbar Disc Herniation Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Kinesiophobia
Keywords
pain, Neuromuscular Stabilization exercises, Kinesiophobia, surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The dynamic neuromuscular stabilization exercises
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
No exercise will be given after surgery
Arm Title
exercise group
Arm Type
Experimental
Arm Description
Dynamic neuromuscular stabilization exercises will be performed for 8 weeks after surgery.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No intervention will be made.
Primary Outcome Measure Information:
Title
The Oswestry Disability Index
Description
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.
Time Frame
10 weeks
Title
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Description
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.
Time Frame
10 weeks
Title
Fear of Daily Living Activities Questionnaire
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Büşra ARISÜT
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Uskudar university
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Şevgin
Email
omer.sevgin@uskudar.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35789639
Citation
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.
Results Reference
background
PubMed Identifier
19610550
Citation
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.
Results Reference
background
PubMed Identifier
31563825
Citation
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.
Results Reference
background
PubMed Identifier
36964655
Citation
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.
Results Reference
background
PubMed Identifier
29097271
Citation
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.
Results Reference
background

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Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery

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