Chronic Neck PainNCT04664842
Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain
A study testing Diaphragmatic Stretch Technique and Breathing Exercise Training in people with Chronic Neck Pain, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Chronic neck pain is a commonly reported problem and often associated with functional disability. Studies showed that patients with chronic neck pain compensated with changes in breathing pattern. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Diaphragmatic Stretch Technique and Breathing Exercise Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 15 Sep 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic or recurrent neck pain from upper cervical to T1 area
- Condition last for 3 months and above
Who cannot join
- Acute neck pain
- Previous neck, shoulder or thoracic surgery
- Neurological disease
- Cardiopulmonary disease（Eg. Chronic obstructive pulmonary disease (COPD), pulmonary tuberculosis (TB), asthma, chronic bronchitis, pulmonary emphysema）
- Smoking
- Pregnancy
Show all 14Show fewer
- Tumour
- Psychological disease
- Neuromuscular disease
- Back pain
- Anaemia or Diabetes
- Neck rehabilitation for past 12 month
- Scoliosis or other diseases that cause spine and chest deformity
- BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain
Chronic neck pain is a commonly reported problem and often associated with functional disability. Studies showed that patients with chronic neck pain compensated with changes in breathing pattern. Primary functions of the diaphragm includes as the main respiratory muscle and contributing to the postural stability and spinal control. Diaphragm is located between the thorax and abdomen and has extensive and complex fascial connections to surrounding organs, muscles, and skeletons. Few studies showed that applying diaphragmatic manual techniques and breathing exercise training help to improve functions in patients with low back pain. However, how does the interventions directly influence on patients with chronic neck pain is still unclear. In this study, we make a hypothesis that diaphragmatic stretch technique and breathing exercise training help to reduce pain and improve functions in patients with chronic neck pain.
Read the detailed description
Chronic neck pain is a serious health problem with low quality of life, disability and economical burdens. Studies have found that nearly 83% of chronic neck pain patients had changes in breathing patterns. Compensated breathing pattern by using the neck-accessory respiratory muscles may result in excessive muscle strains and over-activations, which may also contribute to develop chronic neck pain. The diaphragm is the most important respiratory muscle which attached to the ribs and spine, and thus has an influence on spinal stability. Few studies have showed that diaphragm releasing and breathing training can reduce pain and improve flexibility of posterior chain muscles, spinal range of motions, and ribcage excursions in asymptomatic adults and patients with low back pain. However, the effects in patients with chronic neck pain has not bee determined. Therefore, there are two main purpose of this study. First, to determine the relationships among diaphragm mobility, neck pain and dysfunction, and respiratory in patients with chronic neck pain. Second, to investigate the effects of diaphragm releasing, breathing training, or combined intervention on pain and disability in patients with chronic neck pain. It is expected to recruit 150 patients with chronic neck pain and 30 healthy volunteers. Patients with chronic neck pain will be randomly assigned to (1) manual therapy group (2) manual control group (3) breathing training group (4) general exercise control group (5) manual therapy combined breathing training group. Each participant will receive a specific intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention including ultrasonography, cervical and thoracic function, respiratory functions, and autonomic balance.
- Conditions
- Chronic Neck Pain
- Being tested
- Diaphragmatic Stretch Technique, Breathing Exercise Training
- Keywords
- Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Stretch TechniqueOther
Diaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle fiber length, and improve muscle contraction.
Breathing Exercise TrainingOther
During diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | Not described Receives: Other: Diaphragmatic Stretch Technique |
| Manual Control Group | Sham comparator | Not described Receives: Other: Diaphragmatic Stretch Technique |
| Breathing Training Group | Experimental | Not described Receives: Other: Breathing Exercise Training |
| General Exercise Control Group | Sham comparator | Not described Receives: Other: Breathing Exercise Training |
| Manual Therapy Combined Breathing Training Group | Experimental | Not described Receives: Other: Diaphragmatic Stretch Technique; Other: Breathing Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)
Measured: Change from baseline pain intensity up to 2 weeks
Secondary outcomes (1)
Functional Disability
Neck disability index - Questionnaire
Measured: Change from baseline functional disability up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Aug 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664842
- Sponsor's protocol ID
- NCKU_Diaphragm
- Status last verified
- May 2023
- First submitted
- 4 Sep 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng KC, Hii EYX, Lin YN, Kuo YL, Tsai YJ. Effects of manual diaphragm release on pain, disability and diaphragm function in patients with chronic neck pain: a pilot randomized controlled trial. BMC Complement Med Ther. 2025 Oct 1;25(1):349. doi: 10.1186/s12906-025-05090-8.
PubMed 41034882
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04664842
- Acronym / sponsor ID
- NCKU_Diaphragm
- Conditions
- Chronic Neck Pain
- Keywords
- Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 11 Dec 2020 (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.
Chronic neck pain is a commonly reported problem and often associated with functional disability. Studies showed that patients with chronic neck pain compensated with changes in breathing pattern. Primary functions of the diaphragm includes as the main respiratory muscle and contributing to the postural stability and spinal control. Diaphragm is located between the thorax and abdomen and has extensive and complex fascial connections to surrounding organs, muscles, and skeletons. Few studies showed that applying diaphragmatic manual techniques and breathing exercise training help to improve functions in patients with low back pain. However, how does the interventions directly influence on patients with chronic neck pain is still unclear. In this study, we make a hypothesis that diaphragmatic stretch technique and breathing exercise training help to reduce pain and improve functions in patients with chronic neck pain.
Detailed description
Chronic neck pain is a serious health problem with low quality of life, disability and economical burdens. Studies have found that nearly 83% of chronic neck pain patients had changes in breathing patterns. Compensated breathing pattern by using the neck-accessory respiratory muscles may result in excessive muscle strains and over-activations, which may also contribute to develop chronic neck pain. The diaphragm is the most important respiratory muscle which attached to the ribs and spine, and thus has an influence on spinal stability. Few studies have showed that diaphragm releasing and breathing training can reduce pain and improve flexibility of posterior chain muscles, spinal range of motions, and ribcage excursions in asymptomatic adults and patients with low back pain. However, the effects in patients with chronic neck pain has not bee determined. Therefore, there are two main purpose of this study. First, to determine the relationships among diaphragm mobility, neck pain and dysfunction, and respiratory in patients with chronic neck pain. Second, to investigate the effects of diaphragm releasing, breathing training, or combined intervention on pain and disability in patients with chronic neck pain. It is expected to recruit 150 patients with chronic neck pain and 30 healthy volunteers. Patients with chronic neck pain will be randomly assigned to (1) manual therapy group (2) manual control group (3) breathing training group (4) general exercise control group (5) manual therapy combined breathing training group. Each participant will receive a specific intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention including ultrasonography, cervical and thoracic function, respiratory functions, and autonomic balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Other: Diaphragmatic Stretch Technique |
| Manual Control Group | Sham comparator | Other: Diaphragmatic Stretch Technique |
| Breathing Training Group | Experimental | Other: Breathing Exercise Training |
| General Exercise Control Group | Sham comparator | Other: Breathing Exercise Training |
| Manual Therapy Combined Breathing Training Group | Experimental | Other: Diaphragmatic Stretch Technique, Other: Breathing Exercise Training |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic or recurrent neck pain from upper cervical to T1 area
- Condition last for 3 months and above
Key exclusion criteria (14 listed)
- Acute neck pain
- Previous neck, shoulder or thoracic surgery
- Neurological disease
- Cardiopulmonary disease（Eg. Chronic obstructive pulmonary disease (COPD), pulmonary tuberculosis (TB), asthma, chronic bronchitis, pulmonary emphysema）
- Smoking
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 Stretch TechniqueDiaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle fiber length, and improve muscle contraction. | Other | Manual Control Group, Manual Therapy Combined Breathing Training Group, Manual Therapy Group |
| Breathing Exercise TrainingDuring diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention. | Other | Breathing Training Group, General Exercise Control Group, Manual Therapy Combined Breathing Training Group |
Primary outcome
Pain Intensity
Time frame: Change from baseline pain intensity up to 2 weeks
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)
1 secondary outcome
Functional Disability
Time frame: Change from baseline functional disability up to 2 weeks
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 3 May 2023.
- Derived from this study: PubMed 41034882Cheng KC, Hii EYX, Lin YN, Kuo YL, Tsai YJ. Effects of manual diaphragm release on pain, disability and diaphragm function in patients with chronic neck pain: a pilot randomized controlled trial. BMC Complement Med Ther. 2025 Oct 1;25(1):349. doi: 10.1186/s12906-025-05090-8.
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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 Stretch Technique and Breathing Exercise Training in people with Chronic Neck Pain, 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 2 inclusion and 14 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 3 May 2023. 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. Some participants in this study may receive a placebo. 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 (time frame: Change from baseline pain intensity up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664842, which also lists 1 linked publication.
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 3 May 2023.