Effects Of Dynamic Stabilizatıon Exercises And HVLA Manipulatıon in Low Back Paın

Low Back Pain Clinical Trial

— DNSHVLA  

Official title:

A Comparison Of The Effectiveness Of Dynamic Neuromuscular Stabilizatıon Exercises And Chiropractıc HVLALumbar Manipulatıon in Individuals With Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277700
• Other study ID #: CMT001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Sinop University
• Contact: SEFA HAKTAN HAKTIK
• Phone: +905058761553
• Email: haktanhtk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Chiropractic Manipulation (HVLA - high velocity low amplitude)
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. The participant will then be asked by the physiotherapist to perform a trunk rotation assisted by the throwing arm to reach the lumbar ROM limit. 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
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.

Locations

Country	Name	City	State
Turkey	Sefa Haktan Haktik	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
SEFA HAKTAN HATIK

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	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.	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.
Primary	Physical Adequacy Level	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	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.
Primary	Disability Level	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.	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.
Primary	Dynamic Stabilization and Adaptibility	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.	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.
Primary	Posture	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.	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.