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Clinical Trials/NCT05529641
NCT05529641
Completed
Not Applicable

Effects of Combined Diaphragmatic Resistance Training and Cervical Stabilization Exercise in People With Chronic Neck Pain.

National Cheng Kung University1 site in 1 country71 target enrollmentStarted: December 9, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
71
Locations
1
Primary Endpoint
Pain intensity using Visual Analog Scale (VAS)

Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YI-JU TSAI

Professor

National Cheng Kung University

Study Sites (1)

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