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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Kırşehir, Turkey, 40100
        • Kırsehir Ahi Evran 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 81 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Dynamic neuromuscular stabilization approach
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.
Other: Conventional treatment
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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