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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06005948
Other study ID # Uskudar75
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 6, 2023

Study information

Verified date December 2023
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 6, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility 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 Design


Intervention

Other:
exercise
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
control
No intervention will be made.

Locations

Country Name City State
Turkey Uskudar university Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 weeks
Primary 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. 10 weeks
Primary 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. 10 weeks
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