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Completed

NCT Number: NCT06277700

Effects of Dynamic Stabilizatıon Exercises and HVLA Manipulatıon in Low Back Paın

Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Neuromuscular Subluxation of Joint Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sefa Haktan Haktik

Sinop, Turkey (Türkiye)

About this study

Sixty volunteers aged between 20 and 45 years will participate in this study. Before starting the study, anthropological measurements (height, weight, body mass index) were made. After these measurements, the participants will be randomly divided into four groups.

The groups will be formed as chiropractic manipulation (CM) group (n=15), dynamic neuromuscular stabilization (DNS) group (n=15), CM + DNS group (n=15) and control group (CG) (n=15).

The KM group will receive 8 sessions of High Velocity Low Amplitude (HVLA) chiropractic manipulation twice a week for 4 weeks and the DNS group will receive 8 sessions of (DNS) exercise twice a week for 4 weeks and each session will last 50 minutes. The KM+DNS group will receive a total of 8 sessions of DNS exercises and HVLA chiropractic manipulation twice a week for 4 weeks.

Participants will be assessed a total of 3 times during the study; just before the intervention starts, 2 weeks after the intervention starts, after the 4th session, 4 weeks after completing the intervention, after the 8th session.

Participants will be assessed with Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Dynamic Neuromuscular Stabilization - Heel Slip Test (DNS-HS), Oswety Disability Index (ODI) and posture assessment will be performed using PostureScreen Mobile application.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7 points in Oswetry Disability Index (ODI)
  • Participants should be between the ages of 20 and 45
  • Normal radicular tests
  • Being diagnosed with low back pain 6 months
  • Not having perception problems and being able to cooperate well
  • Signing the voluntary consent form

Exclusion criteria

  • Pregnancy
  • History of previous spinal canal surgery
  • Presence of neurological deficits
  • Presence of cancer
  • Having an inflammatory or rheumatologic disease
  • Spinal deformities (due to infection or trauma, compression fracture)

Treatment and study plan

Chiropractic Manipulation (HVLA - high velocity low amplitude)

Other

Participants in the groups receiving DNS will be asked to hold the lower leg in the side lying position with the lower leg in the extended position and to clamp the upper leg to the lower leg with hip and knee flexion. During the application, the HLVA technique will be applied once by positioning the hypothenar part of the physiotherapist's hand on the transverse process of the lumbar vertebra where tenderness is felt by palpation and vertebral subluxation is thought to be present.

Dynamic Neuromuscular Stabilization

Other

Participants in the groups receiving DNS exercise therapy will be given individualized exercises under the supervision of a physiotherapist. First, the participants were taught posterior diaphragm activation in the supine position and the ability to direct the intraabdominal pressure caudally, while preventing the cranial movement of the thorax, so that the chest and pelvis are in a neutral position and the thoracic diaphragm and pelvis are aligned in parallel. Participants will then be taught the ability to perform a chin tuck without disturbing the alignment of the rib cage. In this way, the cervical diaphragm, thoracic diaphragm and pelvic diaphragm will be aligned in parallel. Our aim in this alignment will be to activate the deep stabilizers as a reflex response to intra-abdominal pressure change with the correct diaphragm movement pattern. Participants will be asked to focus on and maintain this alignment throughout the entire DNS exercise pattern.

Primary outcomes

  1. Visual Analog Scale

    Time frame: This scale will be used to subjectively assess the pain levels of the participants in the 4-week protocol; just before the beginning of the study, in the second week and in the 4th week of the study.

    The pain level of the patients will be measured with this scale. The length of the distance from the starting point of no pain to the location marked by the patient indicates the patient's pain numerically. Pain scoring according to the visual analog scale is usually graded with 0 points as no pain and 10 points as the worst pain imaginable.

  2. Physical Adequacy Level

    Time frame: This scale will be used to subjectively assess the physical adequacy level of the participants in the 4-week protocol; just before the beginning of the study, in the second week and in the 4th week of the study.

    The Roland Morris Disability Questionnaire will be used to assess this parameter. This questionnaire is a subjective assessment method that evaluates the level of physical competence of individuals. The questionnaire consists of 24 items that are answered

  3. Disability Level

    Time frame: This scale will be used to subjectively assess the disability levels of the participants in the 4-week protocol; just before the beginning of the study, in the second week and in the 4th week of the study.

    The Oswetry Disability Index will be used to assess the extent to which individuals' low back pain affects their daily lives and the functional status of the individual. The questionnaire, which consists of 10 questions in total, includes 6 options for each question, the options are scored between 0-5 and the sum of the scores is divided into 5 classes according to the percentile obtained by taking the percentage of the maximum score of the questionnaire.

  4. Dynamic Stabilization and Adaptibility

    Time frame: This scale will be used to subjectively assess the dynamic stabilization and adaptibility levels of the participants in the 4-week protocol; just before the beginning of the study, in the second week and in the 4th week of the study.

    DNS-HS Dynamic Neuromuscular Stabilization - Heel Sliding Test will be used to measure the dynamic stabilization and adaptation level of the participants. The DNS-HS test is useful to objectively measure the dynamic adaptability of core muscles and aid in early diagnosis. It is a promising test that provides objective data that can be used to dynamically assess stabilization ability.

  5. Posture

    Time frame: This mobile app will be used to assess the postural dysfunctions of the participants in the 4-week protocol; just before the beginning of the study, in the second week and in the 4th week of the study.

    PostureScreen to evaluate the posture disorders of the participants. It is a validated and reliable application designed to examine posture and present numerical data with the help of the camera system on mbil devices with Android and iOS operating systems. Participants were asked to wear appropriate clothing so that the upper body and knees remained open during the evaluation, and photographing was performed in static posture on a flat surface and in front of a flat background in front, back and both sides, leaving 3 meters between the participant and the device to be photographed fixed with a tripod. According to the reference points marked on the photograph, postural disorder values and the degree of disorder were calculated for each individual as the degree of deviation from normal posture by means of the software system in the application.

Sponsors and collaborators

Lead sponsor

SEFA HAKTAN HATIK

Other

Registry information

Official study title

A Comparison of the Effectiveness of Dynamic Neuromuscular Stabilizatıon Exercises and Chiropractıc HVLALumbar Manipulatıon in Individuals with Chronic Non-specific Low Back Pain

Acronym: DNSHVLA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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