- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948073
The Effects of Dynamic Neuromuscular Stabilization Approach
April 21, 2022 updated by: Caner Karartı, Hacettepe University
The Effects of Dynamic Neuromuscular Stabilization Approach on Functional Movement Patterns, Balance, Quality of Life, and Exercise Capacity in Older Patients With Chronic Nonspecific Low Back Pain
When the positive effects of the recently popular "Dynamic Neuromuscular Stabilization (DNS)" approach are examined, it suggests that it may be a possible treatment option in geriatric individuals with chronic nonspecific low back pain (CSNLP).
Based on the principles of developmental kinesiology, the DNS approach takes advantage of infants' motor development curves in the treatment of motor disorders.
The main focus is on regulating intra-abdominal pressure and the integrated spinal stabilizing system (ISSS) through specific functional exercises based on the positions exhibited by a healthy infant.
According to the DNS, every developmental position is an exercise position, but every exercise must follow basic principles.
These principles are restoration of correct respiratory pattern and intra-abdominal pressure, respectively; ensuring correct support during dynamic activities of the extremities and ensuring biomechanical alignment during movement.
Considering the principles of exercise, there appears to be a potential mechanism of action for anomalies in geriatric individuals with CNSLBP.
Therefore, in our study, we aimed to examine the effect of DNS approach on functional movement patterns, balance, quality of life and exercise capacity in geriatric individuals with CNSLBP.
It is the first randomized controlled study in the literature, and our hypothesis is that the DNS approach may be an effective therapeutic approach on these parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It has been reported that during isometric upper and lower extremity flexion exercises in individuals with chronic nonspecific low back pain (CSNLP), the mobility of the diaphragm decreases, especially in the anterior-middle portions.
The regulation of intra-abdominal pressure is impaired due to insufficient mobility of the diaphragm and causes compressive forces on the vertebrae due to the compensatory activity of the superficial spinal extensors.
Muscle imbalance between the upper and lower quadrants also results in an abnormal position of the chest or rib cage, negatively affecting lung function and exercise capacity.
When the positive effects of the recently popular "Dynamic Neuromuscular Stabilization (DNS)" approach are examined, it suggests that it may be a possible treatment option in geriatric individuals with CSNLP.
Based on the principles of developmental kinesiology, the DNS approach takes advantage of infants' motor development curves in the treatment of motor disorders.
The main focus is on regulating intra-abdominal pressure and the integrated spinal stabilizing system through specific functional exercises based on the positions exhibited by a healthy infant.
According to the DNS, every developmental position is an exercise position, but every exercise must follow basic principles.
These principles are restoration of correct respiratory pattern and intra-abdominal pressure, respectively; ensuring correct support during dynamic activities of the extremities and ensuring biomechanical alignment during movement.
Considering the principles of exercise, there appears to be a potential mechanism of action for anomalies in geriatric individuals with CNSLBP.
Therefore, in our study, we aimed to examine the effect of DNS approach on functional movement patterns, balance, quality of life and exercise capacity in geriatric individuals with CNSLBP.
It is the first randomized controlled study in the literature, and our hypothesis is that the DNS approach may be an effective therapeutic approach on these parameters.
Study Type
Interventional
Enrollment (Actual)
72
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
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-
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Kırşehir, Turkey, 40100
- Kırşehir Ahi Evran University
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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
63 years to 83 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being an older patient seeking care for CNSLBP (with a duration of at least 3 months) without leg pain.
- To have a pain intensity of at least 3 points (measured on a 0-10 point Visual Analog Scale (VAS);
- The ability to comprehend and follow verbal instructions,
- To be over 65 years of age,
- To volunteer to participate in the study
Exclusion Criteria:
- history of spinal surgery
- severe spinal pathologies (e.g. ankylosing spondylitis, lumbar spinal stenosis, spina bifida, spinal tumors, osteoporosis, and cauda equina syndrome)
- medical contraindications to active exercise;
- concomitant somatic or psychiatric disorder [Mini-Mental State Examination score ≤24]
- neurological deficits (e.g. brain tumor and nerve palsies); specific causes of LBP (e.g. facet joint problem, disc herniation, sacroiliac joint dysfunction)
- nerve root compression
- spinal deformities
- autoimmune diseases (e.g. rheumatoid arthritis and systemic lupus erythematosus)
- cancer
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 |
---|---|
Experimental: Experimental Group
The experimental group will follow a DNS exercise protocol based on previous procedure for a whole period of 6 weeks (three 50-min sessions per week) in addition the conventional treatment.
DNS group's protocol will involve 5 min warm-up, 40 min DNS movements (4 different parts, each part lasts for 10 min) accompanied with breathing exercises, and 5 min cool-down.
DNS exercises will include diaphragmatic breathing, Baby Rock, Rolling, Side Lying, Oblique Sit, Tripod, Kneeling, Squat, Prone, and Czech Get Up (CGU).
Week one specifically will involve training and practicing basic DNS exercises.
The complexity of the exercises will increase gradually by adding a new task to an already practiced task every week.
An increase in the complexity of a task will help the performer to automate performance.
We will use the dual-task paradigm to examine if the task is automated or not (e.g.
no new task should disturb the diaphragmatic breathing).
|
The experimental group will follow a DNS exercise protocol based on previous procedure for a whole period of 6 weeks (three 50-min sessions per week) in addition the conventional treatment.
|
Active Comparator: Control Group
Patients from both groups will receive a conventional 6-week treatment programme (18 treatment sessions, three a week, for 30-40min duration).
All patients will also continue their usual activities and receive advices related to the daily living activites in the form of a leaflet.
Participants will be asked to refrain from seeking any other types of rehabilitation treatments during the trial.
The conventional physical therapy program for both groups includes: TENS therapy for the low back (15 min 3 days/week), with a frequency of 100 Hz and fixed pulse; ultrasound for 5 minutes, 1 Hz, continuous mode of application 1.5 w/cm2.
The exercise programs will consist strengthening, stretching exercises for the abdominal, back, pelvic, and lower limb muscles.
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Patients from both groups will receive a conventional 6-week treatment programme (18 treatment sessions, three a week, for 30-40min duration).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Movement Screening (FMS) [Functional Movement Patterns)
Time Frame: 6 weeks
|
FMS will be used to evaluate the quality of 7 functional movement patterns with the goal of identifying movement limitations and asymmetries.
The FMS consists of 7 individual test items including the deep squat, in-line lunge, hurdle step, shoulder flexibility, push-up, straight leg raise, and rotary trunk stability assessment.
Each of these 7 test items is graded on a scale of 0-3; thus, the lowest and highest possible overall FMS scores are 0 and 21, respectively.
|
6 weeks
|
6-Minute Walk Test (6MWT) [Exercise Capacity]
Time Frame: 6 weeks
|
6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.It provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
Main strengths of the 6MWT stem from its simplicity in concept and performance, low cost, ease of standardization, and acceptance by test subjects, including those who are deconditioned, elderly, or frail.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed-up and go Test (TUG) [Balance]
Time Frame: 6 weeks
|
TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
The TUG is used frequently in the elderly population, as it is easy to administer and can generally be completed by most older adults.
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6 weeks
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WHOQOL-OLD module [Quality of life]
Time Frame: 6 weeks
|
It consists of 24 items assigned to 6 dimensions, the responses to which are determined by the five-level Likert scale.
Higher scores indicate better quality of life.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Scott S, Fuld JP, Carter R, McEntegart M, MacFarlane NG. Diaphragm ultrasonography as an alternative to whole-body plethysmography in pulmonary function testing. J Ultrasound Med. 2006 Feb;25(2):225-32. doi: 10.7863/jum.2006.25.2.225.
- Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21.
- Kolar P, Neuwirth J, Sanda J, Suchanek V, Svata Z, Volejnik J, Pivec M. Analysis of diaphragm movement during tidal breathing and during its activation while breath holding using MRI synchronized with spirometry. Physiol Res. 2009;58(3):383-392. doi: 10.33549/physiolres.931376. Epub 2008 Jul 18.
- Kolar P, Sulc J, Kyncl M, Sanda J, Neuwirth J, Bokarius AV, Kriz J, Kobesova A. Stabilizing function of the diaphragm: dynamic MRI and synchronized spirometric assessment. J Appl Physiol (1985). 2010 Oct;109(4):1064-71. doi: 10.1152/japplphysiol.01216.2009. Epub 2010 Aug 12.
- Mahdieh L, Zolaktaf V, Karimi MT. Effects of dynamic neuromuscular stabilization (DNS) training on functional movements. Hum Mov Sci. 2020 Apr;70:102568. doi: 10.1016/j.humov.2019.102568. Epub 2020 Jan 13.
- Son MS, Jung DH, You JSH, Yi CH, Jeon HS, Cha YJ. Effects of dynamic neuromuscular stabilization on diaphragm movement, postural control, balance and gait performance in cerebral palsy. NeuroRehabilitation. 2017;41(4):739-746. doi: 10.3233/NRE-172155.
- Yoon HS, Cha YJ, You JSH. Effects of dynamic core-postural chain stabilization on diaphragm movement, abdominal muscle thickness, and postural control in patients with subacute stroke: A randomized control trial. NeuroRehabilitation. 2020;46(3):381-389. doi: 10.3233/NRE-192983.
- Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
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)
June 24, 2021
Primary Completion (Actual)
April 4, 2022
Study Completion (Actual)
April 11, 2022
Study Registration Dates
First Submitted
June 24, 2021
First Submitted That Met QC Criteria
June 24, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021500
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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