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临床试验/NCT06277700
NCT06277700已完成不适用

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

SEFA HAKTAN HATIK2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Posture

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Control Group

No Intervention

No treatment will be applied to the control group.

Chiropractic Manipulation (CM) Group

Experimental

In the side lying position, lumbar chiropractic manipulation will be performed over the transverse process of the vertebra thought to have vertebral subluxation. A total of 8 sessions of chiropractic manipulation will be performed 2 times a week.

干预措施: Chiropractic Manipulation (HVLA - high velocity low amplitude) (Other)

Dynamic Neuromuscular Stabilization (DNS) Group

Experimental

Participants in the groups receiving DNS exercise therapy will be given individualized exercises under the supervision of a physiotherapist. Firstly, the participants will be taught the skill of posterior diaphragm activation in the supine position and the ability to direct the intra-abdominal 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. Our aim in this alignment is that with the correct diaphragm movement pattern, the deep stabilizers will be activated as a reflex response to intra-abdominal pressure change. Participants will be asked to focus on and maintain this alignment throughout the entire DNS exercise pattern. Exercises will be done 2 times a week for 50 minutes for 4 weeks.

干预措施: Dynamic Neuromuscular Stabilization (Other)

CM + DNS Group

Experimental

This group receives a treatment as a combination of the treatments described above.

干预措施: Dynamic Neuromuscular Stabilization (Other)

CM + DNS Group

Experimental

This group receives a treatment as a combination of the treatments described above.

干预措施: Chiropractic Manipulation (HVLA - high velocity low amplitude) (Other)

结局指标

主要结局

Posture

时间窗: 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.

Physical Adequacy Level

时间窗: 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

Visual Analog Scale

时间窗: 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.

Dynamic Stabilization and Adaptibility

时间窗: 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.

Disability Level

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
SEFA HAKTAN HATIK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SEFA HAKTAN HATIK

Assistant Professor

Sinop University

研究点 (2)

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