Neck PainNCT05529641
Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain.
A study testing Diaphragmatic resistance training and Cervical stabilization exercise in people with Neck Pain and Diaphragm, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
With increasing usage of electronic devices and sedentary lifestyle, chronic neck pain has become a more prevalent musculoskeletal disorder around the world. Many impairments have been identified in people with chronic neck pain including pain, muscle weakness, proprioceptive deficits and altered breathing pattern. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neck Pain, Diaphragm, Exercise Training
- What is being tested?
- Diaphragmatic resistance training and Cervical stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2022to 31 Aug 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain between nuchal line to T1 spinous process lasting over 3 months.
Who cannot join
- First onset acute neck pain.
- Surgery history.
- Neurological symptoms.
- Respiratory, psychiatric and neuromuscular disorders.
- Smoking, pregnant, cancer.
- Severe anemia or diabetes.
Show all 9Show fewer
- Core exercise in past 12 months.
- Spine or chest deformity.
- Body mass index (BMI) > 30 kg/m/m.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Therapy, National Cheng Kung University
Tainan, 701
About this study
Official title: Effects of Combined Diaphragmatic Resistance Training and Cervical Stabilization Exercise in People With Chronic Neck Pain.
With increasing usage of electronic devices and sedentary lifestyle, chronic neck pain has become a more prevalent musculoskeletal disorder around the world. Many impairments have been identified in people with chronic neck pain including pain, muscle weakness, proprioceptive deficits and altered breathing pattern. Diaphragm is the key muscle for inspiration and also plays an important role in spinal stability. Previous studies have found that diaphragm functions are related to the stability of the lumbar spine through the fascial, neural and visceral systems. Diaphragmatic resistance training thus could have some positive effects on reducing pain and disability in people with low back pain. However, to date how diaphragmatic resistance training would affect chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of diaphragmatic resistance training on pain, disability and movement quality in people with chronic neck pain.
Read the detailed description
Chronic neck pain has become a more prevalent musculoskeletal disorder in modern society. The prevalence of chronic neck pain in 2021 gradually increases to 45.7%, that results in a large burden of health care. Chronic neck pain leads to neck motion limitation, motor control impairment and unsmooth motion. In addition, faulty breathing pattern has been identified in 83% of people with chronic neck pain. Diaphragm is the most critical muscle for inspiration and also plays an important role in spinal stability that might relate to spinal instability and pain. Studies have proved that effects of diaphragmatic resistance training on reduce pain and improving quality of life in people with low back pain. Diaphragm connects to the lumbar spine and also to the cervical spine through the fascial, neural and visceral system. However, to our best knowledge, the effects of diaphragmatic resistance training in people with chronic neck pain is still unclear. While many studies have demonstrated that cervical stabilization exercises are able to decrease pain and disability and improve movement quality, the effects of combined diaphragmatic resistance training and cervical stabilization exercise in people with chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of 6 weeks of diaphragmatic resistance training in combination with cervical stabilization exercises in people with chronic neck pain. Participants with chronic neck pain will be randomly assigned to either (1) combined diaphragmatic resistance training and cervical stabilization exercise group or (2) cervical stabilization exercise group. Each group will receive the same cervical stabilization exercises while group (1) will receive additional diaphragmatic resistance training as home program. All participants will have 2 evaluation sessions at baseline and after 6-week intervention for pain, disability and movement quality.
- Conditions
- Neck Pain, Diaphragm, Exercise Training, Inhalation
- Being tested
- Diaphragmatic resistance training, Cervical stabilization exercise
- Keywords
- Chronic neck pain, Kinematics, Diaphragm, Diaphragmatic resistance training, Stabilization exercise
- Medical subject headings
- Neck Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic resistance trainingOther
6 weeks home exercise of diaphragmatic resistance training will be emphasized.
Cervical stabilization exerciseOther
Participants will finish 6 weeks supervised cervical stabilization exercise in person by physical therapist. Dissociated movement and movement control will be emphasized during cervical stabilization exercise.
| Study group | Role | What they receive |
|---|---|---|
| Combined diaphragmatic resistance training and cervical stabilization exercise group | Experimental | Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram. Receives: Other: Diaphragmatic resistance training; Other: Cervical stabilization exercise |
| Cervical stabilization exercise group | Active comparator | Participants in this group will only receive supervised cervical stabilization exercise. Receives: Other: Cervical stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using Visual Analog Scale (VAS)
Visual Analog Scale (VAS), a self-reported scale, provides 100 mm line that participants will mark the maximal and averaged pain intensity within past 7 days. The length of the line that participants marked would be the intensity of pain. The minimal value will be 0 mm and maximal value will be 100 mm. The longer the length indicates the higher intensity of pain.
Measured: Changes from baseline to 6 weeks when participants finish the intervention.
Disability using Neck Disability Index (NDI)
Neck Disability Index (NDI), a self-reported scale, contains 10 sessions of question to evaluating how severe that functional activity level was affected by neck pain. Each session scores ranging from 0 to 5. Total score range from 0 to 50. The higher the score indicates more disability level.
Measured: Changes from baseline to 6 weeks when participants finish the intervention.
Cervical kinematics
Using optical motion analysis system to assess cervical kinematics for movement quality.
Measured: Changes from baseline to 6 weeks when participants finish the intervention.
Muscle activation
Using surface electromyogram to assess muscle activation pattern.
Measured: Changes from baseline to 6 weeks when participants finish the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start9 Dec 2022
- Primary completion31 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529641
- Sponsor's protocol ID
- NCKU-DRT-2022
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Diaphragmatic Resistance Training and Cervical Stabilization Exercise in People With Chronic Neck Pain.
- ClinicalTrials.gov ID
- NCT05529641
- Acronym / sponsor ID
- NCKU-DRT-2022
- Conditions
- Neck Pain, Diaphragm, Exercise Training, Inhalation
- Keywords
- Chronic neck pain, Kinematics, Diaphragm, Diaphragmatic resistance training, Stabilization exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 7 Sep 2022 (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.
With increasing usage of electronic devices and sedentary lifestyle, chronic neck pain has become a more prevalent musculoskeletal disorder around the world. Many impairments have been identified in people with chronic neck pain including pain, muscle weakness, proprioceptive deficits and altered breathing pattern. Diaphragm is the key muscle for inspiration and also plays an important role in spinal stability. Previous studies have found that diaphragm functions are related to the stability of the lumbar spine through the fascial, neural and visceral systems. Diaphragmatic resistance training thus could have some positive effects on reducing pain and disability in people with low back pain. However, to date how diaphragmatic resistance training would affect chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of diaphragmatic resistance training on pain, disability and movement quality in people with chronic neck pain.
Detailed description
Chronic neck pain has become a more prevalent musculoskeletal disorder in modern society. The prevalence of chronic neck pain in 2021 gradually increases to 45.7%, that results in a large burden of health care. Chronic neck pain leads to neck motion limitation, motor control impairment and unsmooth motion. In addition, faulty breathing pattern has been identified in 83% of people with chronic neck pain. Diaphragm is the most critical muscle for inspiration and also plays an important role in spinal stability that might relate to spinal instability and pain. Studies have proved that effects of diaphragmatic resistance training on reduce pain and improving quality of life in people with low back pain. Diaphragm connects to the lumbar spine and also to the cervical spine through the fascial, neural and visceral system. However, to our best knowledge, the effects of diaphragmatic resistance training in people with chronic neck pain is still unclear. While many studies have demonstrated that cervical stabilization exercises are able to decrease pain and disability and improve movement quality, the effects of combined diaphragmatic resistance training and cervical stabilization exercise in people with chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of 6 weeks of diaphragmatic resistance training in combination with cervical stabilization exercises in people with chronic neck pain. Participants with chronic neck pain will be randomly assigned to either (1) combined diaphragmatic resistance training and cervical stabilization exercise group or (2) cervical stabilization exercise group. Each group will receive the same cervical stabilization exercises while group (1) will receive additional diaphragmatic resistance training as home program. All participants will have 2 evaluation sessions at baseline and after 6-week intervention for pain, disability and movement quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined diaphragmatic resistance training and cervical stabilization exercise group | Experimental | Other: Diaphragmatic resistance training, Other: Cervical stabilization exerciseParticipants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram. |
| Cervical stabilization exercise group | Active comparator | Other: Cervical stabilization exerciseParticipants in this group will only receive supervised cervical stabilization exercise. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pain between nuchal line to T1 spinous process lasting over 3 months.
Key exclusion criteria (9 listed)
- First onset acute neck pain.
- Surgery history.
- Neurological symptoms.
- Respiratory, psychiatric and neuromuscular disorders.
- Smoking, pregnant, cancer.
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 |
|---|---|---|
| Diaphragmatic resistance training6 weeks home exercise of diaphragmatic resistance training will be emphasized. | Other | Combined diaphragmatic resistance training and cervical stabilization exercise group |
| Cervical stabilization exerciseParticipants will finish 6 weeks supervised cervical stabilization exercise in person by physical therapist. Dissociated movement and movement control will be emphasized during cervical stabilization exercise. | Other | Cervical stabilization exercise group, Combined diaphragmatic resistance training and cervical stabilization exercise group |
Primary outcome
Pain intensity using Visual Analog Scale (VAS)
Time frame: Changes from baseline to 6 weeks when participants finish the intervention.
Visual Analog Scale (VAS), a self-reported scale, provides 100 mm line that participants will mark the maximal and averaged pain intensity within past 7 days. The length of the line that participants marked would be the intensity of pain. The minimal value will be 0 mm and maximal value will be 100 mm. The longer the length indicates the higher intensity of pain.
Disability using Neck Disability Index (NDI)
Time frame: Changes from baseline to 6 weeks when participants finish the intervention.
Neck Disability Index (NDI), a self-reported scale, contains 10 sessions of question to evaluating how severe that functional activity level was affected by neck pain. Each session scores ranging from 0 to 5. Total score range from 0 to 50. The higher the score indicates more disability level.
Cervical kinematics
Time frame: Changes from baseline to 6 weeks when participants finish the intervention.
Using optical motion analysis system to assess cervical kinematics for movement quality.
Muscle activation
Time frame: Changes from baseline to 6 weeks when participants finish the intervention.
Using surface electromyogram to assess muscle activation pattern.
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 5 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic resistance training and Cervical stabilization exercise in people with Neck Pain and Diaphragm, run by National Cheng Kung University at 1 site in Taiwan.
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 1 inclusion and 9 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 5 Dec 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 Taiwan. 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?
Pain intensity using Visual Analog Scale (VAS) (time frame: Changes from baseline to 6 weeks when participants finish the intervention.). The study lists 4 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 5 Dec 2025.