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The Effects of Dynamic Neuromuscular Stabilization Approach

Primary Purpose

Low Back Pain, Rehabilitation, Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dynamic neuromuscular stabilization approach
Conventional treatment
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, rehabilitation, stabilization, exercises, balance

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırşehir Ahi Evran University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Functional Movement Screening (FMS) [Functional Movement Patterns)
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-Minute Walk Test (6MWT) [Exercise Capacity]
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.

Secondary Outcome Measures

Timed-up and go Test (TUG) [Balance]
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.
WHOQOL-OLD module [Quality of life]
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.

Full Information

First Posted
June 24, 2021
Last Updated
April 21, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04948073
Brief Title
The Effects of Dynamic Neuromuscular Stabilization Approach
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Rehabilitation, Treatment
Keywords
low back pain, rehabilitation, stabilization, exercises, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Masking Description
the blinded assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic neuromuscular stabilization approach
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Patients from both groups will receive a conventional 6-week treatment programme (18 treatment sessions, three a week, for 30-40min duration).
Primary Outcome Measure Information:
Title
Functional Movement Screening (FMS) [Functional Movement Patterns)
Description
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.
Time Frame
6 weeks
Title
6-Minute Walk Test (6MWT) [Exercise Capacity]
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Timed-up and go Test (TUG) [Balance]
Description
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.
Time Frame
6 weeks
Title
WHOQOL-OLD module [Quality of life]
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kırşehir Ahi Evran University
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22236541
Citation
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.
Results Reference
background
PubMed Identifier
16439786
Citation
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.
Results Reference
background
PubMed Identifier
18637703
Citation
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.
Results Reference
background
PubMed Identifier
20705944
Citation
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.
Results Reference
background
PubMed Identifier
31950895
Citation
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.
Results Reference
background
PubMed Identifier
29254112
Citation
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.
Results Reference
background
PubMed Identifier
32250328
Citation
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.
Results Reference
background
PubMed Identifier
23411647
Citation
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.
Results Reference
background

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The Effects of Dynamic Neuromuscular Stabilization Approach

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