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Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain.

Primary Purpose

Neck Pain, Diaphragm, Exercise Training

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Diaphragmatic resistance training
Cervical stabilization exercise
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Chronic neck pain, Kinematics, Diaphragm, Diaphragmatic resistance training, Stabilization exercise

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Therapy, National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined diaphragmatic resistance training and cervical stabilization exercise group

Cervical stabilization exercise group

Arm Description

Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.

Participants in this group will only receive supervised cervical stabilization exercise.

Outcomes

Primary Outcome Measures

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.
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.
Cervical kinematics
Using optical motion analysis system to assess cervical kinematics for movement quality.
Muscle activation
Using surface electromyogram to assess muscle activation pattern.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2022
Last Updated
May 1, 2023
Sponsor
National Cheng Kung University
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05529641
Brief Title
Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain.
Official Title
Effects of Combined Diaphragmatic Resistance Training and Cervical Stabilization Exercise in People With Chronic Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Diaphragm, Exercise Training, Inhalation
Keywords
Chronic neck pain, Kinematics, Diaphragm, Diaphragmatic resistance training, Stabilization exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined diaphragmatic resistance training and cervical stabilization exercise group
Arm Type
Experimental
Arm Description
Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.
Arm Title
Cervical stabilization exercise group
Arm Type
Active Comparator
Arm Description
Participants in this group will only receive supervised cervical stabilization exercise.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic resistance training
Intervention Description
6 weeks home exercise of diaphragmatic resistance training will be emphasized.
Intervention Type
Other
Intervention Name(s)
Cervical stabilization exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity using Visual Analog Scale (VAS)
Description
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.
Time Frame
Changes from baseline to 6 weeks when participants finish the intervention.
Title
Disability using Neck Disability Index (NDI)
Description
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.
Time Frame
Changes from baseline to 6 weeks when participants finish the intervention.
Title
Cervical kinematics
Description
Using optical motion analysis system to assess cervical kinematics for movement quality.
Time Frame
Changes from baseline to 6 weeks when participants finish the intervention.
Title
Muscle activation
Description
Using surface electromyogram to assess muscle activation pattern.
Time Frame
Changes from baseline to 6 weeks when participants finish the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ju Tsai
Phone
+886-6-2353535
Ext
5021
Email
lulilutsai@gmail.com
Facility Information:
Facility Name
Department of Physical Therapy, National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Chia Cheng, Bachlor
Phone
+886-6-2353535
Ext
5930
Email
kaichiacheng@gmail.com
First Name & Middle Initial & Last Name & Degree
Yi-Ju Tsai, PhD

12. IPD Sharing Statement

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Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain.

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