Low Back PainDNSHVLANCT06277700
Effects of Dynamic Stabilizatıon Exercises and HVLA Manipulatıon in Low Back Paın
A study testing Chiropractic Manipulation (HVLA - high velocity low amplitude) and Dynamic Neuromuscular Stabilization in people with Low Back Pain and Neuromuscular Subluxation of Joint, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neuromuscular Subluxation of Joint
- What is being tested?
- Chiropractic Manipulation (HVLA - high velocity low amplitude) and Dynamic Neuromuscular Stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Jun 2024
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Low Back Pain, Neuromuscular Subluxation of Joint
- Being tested
- Chiropractic Manipulation (HVLA - high velocity low amplitude), Dynamic Neuromuscular Stabilization
- Keywords
- Spinal Manipulation, Dynamic Neuromuscular Stabilization, Low Back Pain, Posture, Non - spesific
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 StabilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chiropractic Manipulation (HVLA - high velocity low amplitude) |
| 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. Receives: Other: Dynamic Neuromuscular Stabilization |
| CM + DNS Group | Experimental | This group receives a treatment as a combination of the treatments described above. Receives: Other: Chiropractic Manipulation (HVLA - high velocity low amplitude); Other: Dynamic Neuromuscular Stabilization |
| Control Group | No intervention | No treatment will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 people will participate in the study and the participants will be 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). Chiropractic manipulation will be performed once in the side-lying position. An individualized exercise program will be applied to the DNS group under the supervision of a physiotherapist. Kruskal Wallis test for comparisons of quantitative variables between 4 independent groups; Mann Whitney U test with Bonferonni correction will be used in double subgroup comparisons of significant variables. Friedman test was used for comparisons of quantitative variables in 3 dependent groups. Wilcoxon test with Bonferonni correction will be used for two-way subgroup comparisons for significant variables. In all statistical analyzes in the study, results with a p value below 0.05 will be considered statistically significant.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA HAKTAN HATIK, Study director, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277700
- Sponsor's protocol ID
- CMT001
- Acronym
- DNSHVLA
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06277700
- Acronym / sponsor ID
- DNSHVLA / CMT001
- Conditions
- Low Back Pain, Neuromuscular Subluxation of Joint
- Keywords
- Spinal Manipulation, Dynamic Neuromuscular Stabilization, Low Back Pain, Posture, Non - spesific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 60 people will participate in the study and the participants will be 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). Chiropractic manipulation will be performed once in the side-lying position. An individualized exercise program will be applied to the DNS group under the supervision of a physiotherapist. Kruskal Wallis test for comparisons of quantitative variables between 4 independent groups; Mann Whitney U test with Bonferonni correction will be used in double subgroup comparisons of significant variables. Friedman test was used for comparisons of quantitative variables in 3 dependent groups. Wilcoxon test with Bonferonni correction will be used for two-way subgroup comparisons for significant variables. In all statistical analyzes in the study, results with a p value below 0.05 will be considered statistically significant.
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Manipulation (CM) Group | Experimental | Other: Chiropractic Manipulation (HVLA - high velocity low amplitude)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. |
| Dynamic Neuromuscular Stabilization (DNS) Group | Experimental | Other: Dynamic Neuromuscular StabilizationParticipants 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. |
| CM + DNS Group | Experimental | Other: Chiropractic Manipulation (HVLA - high velocity low amplitude), Other: Dynamic Neuromuscular StabilizationThis group receives a treatment as a combination of the treatments described above. |
| Control Group | No intervention | –No treatment will be applied to the control group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- History of previous spinal canal surgery
- Presence of neurological deficits
- Presence of cancer
- Having an inflammatory or rheumatologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. 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. | Other | CM + DNS Group, Chiropractic Manipulation (CM) Group |
| Dynamic Neuromuscular StabilizationParticipants 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. | Other | CM + DNS Group, Dynamic Neuromuscular Stabilization (DNS) Group |
Primary outcome
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.
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA HAKTAN HATIK study director
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Manipulation (HVLA - high velocity low amplitude) and Dynamic Neuromuscular Stabilization in people with Low Back Pain and Neuromuscular Subluxation of Joint, run by SEFA HAKTAN HATIK 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 6 inclusion and 6 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 20 Sep 2024. 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?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.