NCT06005948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

August 15, 2023

Last Update Submit

January 3, 2025

Conditions

Keywords

painNeuromuscular Stabilization exercisesKinesiophobiasurgical

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

control group

ACTIVE COMPARATOR

No exercise will be given after surgery

Other: control

exercise group

EXPERIMENTAL

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

Other: exercise

Interventions

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

exercise group
controlOTHER

No intervention will be made.

control group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between 30 and 50 years old.
  • Having undergone lumbar disc hernia surgery.
  • Having access to a computer/tablet/phone and internet.

You may not qualify if:

  • Having cognitive, mental or psychological problems.
  • Having a visual or hearing impairment.
  • Having a physical condition that causes significant loss of function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar university

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 35789639BACKGROUND
  • 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.

    PMID: 19610550BACKGROUND
  • 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.

    PMID: 31563825BACKGROUND
  • 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.

    PMID: 36964655BACKGROUND
  • 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.

    PMID: 29097271BACKGROUND

MeSH Terms

Conditions

Low Back PainKinesiophobiaPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Büşra ARISÜT

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The dynamic neuromuscular stabilization exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

November 28, 2023

Study Completion

December 6, 2023

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations