- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529641
Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain.
November 27, 2025 updated by: YI-JU TSAI, National Cheng Kung University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tainan, Taiwan, 701
- Department of Physical Therapy, National Cheng Kung University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pain between nuchal line to T1 spinous process lasting over 3 months.
Exclusion Criteria:
- First onset acute neck pain.
- Surgery history.
- Neurological symptoms.
- Respiratory, psychiatric and neuromuscular disorders.
- Smoking, pregnant, cancer.
- Severe anemia or diabetes.
- Core exercise in past 12 months.
- Spine or chest deformity.
- Body mass index (BMI) > 30 kg/m/m.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined diaphragmatic resistance training and cervical stabilization exercise group
Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.
|
6 weeks home exercise of diaphragmatic resistance training will be emphasized.
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.
|
|
Active Comparator: Cervical stabilization exercise group
Participants in this group will only receive supervised cervical stabilization exercise.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Changes from baseline to 6 weeks when participants finish the intervention.
|
|
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.
|
Changes from baseline to 6 weeks when participants finish the intervention.
|
|
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.
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Changes from baseline to 6 weeks when participants finish the intervention.
|
|
Muscle activation
Time Frame: Changes from baseline to 6 weeks when participants finish the intervention.
|
Using surface electromyogram to assess muscle activation pattern.
|
Changes from baseline to 6 weeks when participants finish the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2022
Primary Completion (Actual)
May 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 27, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCKU-DRT-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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