Non-specific Neck PainNCT06891391
Comparison of Dynamic Neuromuscular Stabilization Exercises and Deep Cervical Muscle Exercises on Muscle Fat Infiltration in Individuals With Neck Pain
A study testing Dynamic Neuromuscular Stabilization exercises and Deep Cervical Muscle exercises in people with Non-specific Neck Pain, run by Tokyo Metropolitan University at 1 site in Japan.
Trial summary
This clinical trial study aims to compare the effects of DNS (Dynamic Neuromuscular Stabilization) exercises and deep cervical muscle exercises on fat infiltration, disability, and posture in individuals with chronic non-specific neck pain. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Non-specific Neck Pain
- What is being tested?
- Dynamic Neuromuscular Stabilization exercises and Deep Cervical Muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- 10 Apr 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific neck pain condition for three months or more
- Mild to moderate disability ( more than 10% of NDI)
- Mild to moderate pain level(2-8/10 of NRS)
Who cannot join
- A history of spine surgery or cervical injury
- Participated in a neck exercise program in the past three months
- Upper extremity problems
- Radiating pain, numbness, and weakness of the upper extremities
- A detectable pathological spinal condition
- Metabolic disorders, diabetes, and hypertension Obesity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hironobu Kuruma, Professor contact
About this study
This clinical trial study aims to compare the effects of DNS (Dynamic Neuromuscular Stabilization) exercises and deep cervical muscle exercises on fat infiltration, disability, and posture in individuals with chronic non-specific neck pain. The clinical questions of this study are as follows:
- Can DNS and deep cervical muscle exercises decrease muscle fat infiltration?
- Can DNS and deep cervical muscle exercises improve neck disability?
- Can DNS and deep cervical muscle exercises improve neck posture?
Read more
Researchers will compare DNS and deep cervical muscle exercises to people with non-specific neck pain. DNS exercises are hypothesized to significantly reduce fat infiltration and improve neck disability and neck posture compared to deep cervical muscle exercises.
The participants will undergo an MRI scan and clinical assessment, such as NDI (Neck Disability Index) and posture checking, before being randomly divided into two groups. The first group will perform DNS exercises, and the second group will engage in deep cervical muscle exercises. Both sets of exercises will be performed for 16 weeks as part of a daily routine. After the 16-week exercises, the participants will undergo a follow-up MRI, NDI, and posture checking.
- Conditions
- Non-specific Neck Pain
- Being tested
- Dynamic Neuromuscular Stabilization exercises, Deep Cervical Muscle exercises
- Keywords
- Dynamic neuromuscular stabilization, Deep neck muscle exercise, Fatty infiltration, Medical resonance imaging, Non-specific neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Neuromuscular Stabilization exercisesOther
DNS is a method used to enhance muscle stability. It is a manual and rehabilitative approach based on developmental kinesiology to optimize the movement system. These exercises optimize internal muscle forces on each spinal segment.
Deep Cervical Muscle exercisesOther
Deep cervical muscle exercises are isometric exercises that strengthen weak muscles without causing discomfort to pain-sensitive structures like ligaments, tendons, or neck joints. This involves contracting specific muscles without changing muscle length or impeding joint movement.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants will perform three DNS exercise positions based on their ability: the 3-month prone developmental position, the 6-month developmental position, and the quadruped position. Each position will be done 3-6 repetitions and actively held for 30 to 60 seconds. Participants will perform both exercises at home twice daily, adjusting based on their ability and ensuring they do not experience pain. Receives: Other: Dynamic Neuromuscular Stabilization exercises |
| Group B | Active comparator | Participants will perform two types of exercises: Deep Cervical Flexor Training and Deep Cervical Extensor Training. For flexor training, they will lie on their back with a small towel under the suboccipital region and slowly move their head to the inner range. This will be done in sets of 10 repetitions with a 30-second rest between sets. For extensor training, they will sit upright with their hands folded below the occiput, pushing into extension against their hands and holding the posture as long as possible. This exercise consists of 3 sets of 6 repetitions, with a 6-second rest between repetitions and a 30-seconds break between sets. Participants will perform both exercises at home twice in 6 days a week, adjusting based on their ability and ensuring they do not experience pain. Receives: Other: Deep Cervical Muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle fat infiltration in the flexor and extensor muscles
All participants will be conducted a standard MRI of the cervical spine. They will be asked to lie on their backs and maintain a neutral cervical spine position without rotation, lateral flexion, or exaggerated lordosis. A neck coil will be used during the examination to enhance imaging accuracy. MRI will be performed using the SIGNA Premier 3.OT (GE Healthcare Japan) (Repetition time, 8000 ms; Excitation time, 102 ms; Voxel size, 0.4 x 0.4 mm; Field of view, 200 x 200 mm; Thickness, 3.5 mm). Specific neck muscles (Longus Colli + capitis, Multifidus, Semispinalis cervicis, Semispinalis capitis, and Splenius capitis + cervicis) will be mapped and analyzed for fatty infiltration using Miele-lxiv image processing software. The total fatty infiltration for bilateral muscles at different levels in the neck will be calculated.
Measured: 16 weeks
Change of disability level
The Neck Disability Index (NDI) is a 10-question survey that measures how neck pain affects daily life. The patient rates their pain intensity, headaches, and difficulty with personal care, lifting, reading, concentration, work, driving, sleeping, and recreation. A change of 5%-10% is considered meaningful.
Measured: 16 weeks
Change of posture
Shisei-Karte is a Japanese AI-based website that analyzes posture using images. It assesses head posture, including forward and backward tilts and misalignment. The goal is to detect issues like forward head posture. The process has three steps: (1) participants register with basic details, (2) a side-view photo is taken, and (3) the AI analyzes and displays results in about 30 seconds.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion29 Aug 2025 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Neck 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hardianty A.M Abduh, M. Sc, Study chair, Tokyo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891391
- Sponsor's protocol ID
- 24072
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Neuromuscular Stabilization Exercises and Deep Cervical Muscle Exercises on Muscle Fat Infiltration in Individuals With Neck Pain
- ClinicalTrials.gov ID
- NCT06891391
- Acronym / sponsor ID
- 24072
- Conditions
- Non-specific Neck Pain
- Keywords
- Dynamic neuromuscular stabilization, Deep neck muscle exercise, Fatty infiltration, Medical resonance imaging, Non-specific neck pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tokyo Metropolitan UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
This clinical trial study aims to compare the effects of DNS (Dynamic Neuromuscular Stabilization) exercises and deep cervical muscle exercises on fat infiltration, disability, and posture in individuals with chronic non-specific neck pain. The clinical questions of this study are as follows:
- Can DNS and deep cervical muscle exercises decrease muscle fat infiltration?
- Can DNS and deep cervical muscle exercises improve neck disability?
- Can DNS and deep cervical muscle exercises improve neck posture?
Researchers will compare DNS and deep cervical muscle exercises to people with non-specific neck pain. DNS exercises are hypothesized to significantly reduce fat infiltration and improve neck disability and neck posture compared to deep cervical muscle exercises.
The participants will undergo an MRI scan and clinical assessment, such as NDI (Neck Disability Index) and posture checking, before being randomly divided into two groups. The first group will perform DNS exercises, and the second group will engage in deep cervical muscle exercises. Both sets of exercises will be performed for 16 weeks as part of a daily routine. After the 16-week exercises, the participants will undergo a follow-up MRI, NDI, and posture checking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Dynamic Neuromuscular Stabilization exercisesParticipants will perform three DNS exercise positions based on their ability: the 3-month prone developmental position, the 6-month developmental position, and the quadruped position. Each position will be done 3-6 repetitions and actively held for 30 to 60 seconds. Participants will perform both exercises at home twice daily, adjusting based on their ability and ensuring they do not experience pain. |
| Group B | Active comparator | Other: Deep Cervical Muscle exercisesParticipants will perform two types of exercises: Deep Cervical Flexor Training and Deep Cervical Extensor Training. For flexor training, they will lie on their back with a small towel under the suboccipital region and slowly move their head to the inner range. This will be done in sets of 10 repetitions with a 30-second rest between sets. For extensor training, they will sit upright with their hands folded below the occiput, pushing into extension against their hands and holding the posture as long as possible. This exercise consists of 3 sets of 6 repetitions, with a 6-second rest between repetitions and a 30-seconds break between sets. Participants will perform both exercises at home twice in 6 days a week, adjusting based on their ability and ensuring they do not experience pain. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-specific neck pain condition for three months or more
- Mild to moderate disability ( more than 10% of NDI)
- Mild to moderate pain level(2-8/10 of NRS)
Key exclusion criteria (6 listed)
- A history of spine surgery or cervical injury
- Participated in a neck exercise program in the past three months
- Upper extremity problems
- Radiating pain, numbness, and weakness of the upper extremities
- A detectable pathological spinal condition
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 |
|---|---|---|
| Dynamic Neuromuscular Stabilization exercisesDNS is a method used to enhance muscle stability. It is a manual and rehabilitative approach based on developmental kinesiology to optimize the movement system. These exercises optimize internal muscle forces on each spinal segment. | Other | Group A |
| Deep Cervical Muscle exercisesDeep cervical muscle exercises are isometric exercises that strengthen weak muscles without causing discomfort to pain-sensitive structures like ligaments, tendons, or neck joints. This involves contracting specific muscles without changing muscle length or impeding joint movement. | Other | Group B |
Primary outcome
Change of muscle fat infiltration in the flexor and extensor muscles
Time frame: 16 weeks
All participants will be conducted a standard MRI of the cervical spine. They will be asked to lie on their backs and maintain a neutral cervical spine position without rotation, lateral flexion, or exaggerated lordosis. A neck coil will be used during the examination to enhance imaging accuracy. MRI will be performed using the SIGNA Premier 3.OT (GE Healthcare Japan) (Repetition time, 8000 ms; Excitation time, 102 ms; Voxel size, 0.4 x 0.4 mm; Field of view, 200 x 200 mm; Thickness, 3.5 mm). Specific neck muscles (Longus Colli + capitis, Multifidus, Semispinalis cervicis, Semispinalis capitis, and Splenius capitis + cervicis) will be mapped and analyzed for fatty infiltration using Miele-lxiv image processing software. The total fatty infiltration for bilateral muscles at different levels in the neck will be calculated.
Change of disability level
Time frame: 16 weeks
The Neck Disability Index (NDI) is a 10-question survey that measures how neck pain affects daily life. The patient rates their pain intensity, headaches, and difficulty with personal care, lifting, reading, concentration, work, driving, sleeping, and recreation. A change of 5%-10% is considered meaningful.
Change of posture
Time frame: 16 weeks
Shisei-Karte is a Japanese AI-based website that analyzes posture using images. It assesses head posture, including forward and backward tilts and misalignment. The goal is to detect issues like forward head posture. The process has three steps: (1) participants register with basic details, (2) a side-view photo is taken, and (3) the AI analyzes and displays results in about 30 seconds.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Hironobu Kuruma, Professor contact
Hardianty A.M Abduh, M. Sc study chair
Tokyo Metropolitan 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 Dynamic Neuromuscular Stabilization exercises and Deep Cervical Muscle exercises in people with Non-specific Neck Pain, run by Tokyo Metropolitan University at 1 site in Japan.
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 3 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: opening soon, as of the sponsor's last update on 24 Mar 2025. 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 Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hardianty A.M Abduh, M. Sc (+819078806110, hardiantymunabduh9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle fat infiltration in the flexor and extensor muscles (time frame: 16 weeks). The study lists 3 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 24 Mar 2025.