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Low Back PainNCT04948073

The Effects of Dynamic Neuromuscular Stabilization Approach

A study testing Dynamic neuromuscular stabilization approach and Conventional treatment in people with Low Back Pain and Rehabilitation, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Low Back Pain, Rehabilitation, Treatment
What is being tested?
Dynamic neuromuscular stabilization approach and Conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jun 2021to 11 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • spinal deformities
  • autoimmune diseases (e.g. rheumatoid arthritis and systemic lupus erythematosus)
  • cancer

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırşehir Ahi Evran University

    Kırşehir, 40100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Dynamic neuromuscular stabilization approach, Conventional treatment
Keywords
low back pain, rehabilitation, stabilization, exercises, balance
Medical subject headings
Low Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic neuromuscular stabilization approachOther

    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.

  • Conventional treatmentOther

    Patients from both groups will receive a conventional 6-week treatment programme (18 treatment sessions, three a week, for 30-40min duration).

Study groups in NCT04948073
Study groupRoleWhat they receive
Experimental GroupExperimentalThe 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).
Receives: Other: Dynamic neuromuscular stabilization approach
Control GroupActive comparatorPatients 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.
Receives: Other: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study start24 Jun 2021
  3. Primary completion4 Apr 2022
  4. Study completion11 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04948073
Sponsor's protocol ID
2021500
Status last verified
Apr 2022
First submitted
24 Jun 2021
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22236541
  • 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.

    PubMed 16439786
  • 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.

    PubMed 18637703
  • 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.

    PubMed 20705944
  • 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.

    PubMed 31950895
  • 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.

    PubMed 29254112
  • 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.

    PubMed 32250328
  • 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.

    PubMed 23411647

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic neuromuscular stabilization approach and Conventional treatment in people with Low Back Pain and Rehabilitation, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Movement Screening (FMS) [Functional Movement Patterns) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04948073, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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