search
Back to results

Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Diaphragmatic Stretch Technique
Breathing Exercise Training
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Chronic or recurrent neck pain from upper cervical to T1 area
  • Condition last for 3 months and above

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Arm Label

Manual Therapy Group

Manual Control Group

Breathing Training Group

General Exercise Control Group

Manual Therapy Combined Breathing Training Group

Arm Description

Outcomes

Primary Outcome Measures

Pain Intensity
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)

Secondary Outcome Measures

Functional Disability
Neck disability index - Questionnaire

Full Information

First Posted
September 4, 2020
Last Updated
May 1, 2023
Sponsor
National Cheng Kung University
search

1. Study Identification

Unique Protocol Identification Number
NCT04664842
Brief Title
Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain
Official Title
Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy Group
Arm Type
Experimental
Arm Title
Manual Control Group
Arm Type
Sham Comparator
Arm Title
Breathing Training Group
Arm Type
Experimental
Arm Title
General Exercise Control Group
Arm Type
Sham Comparator
Arm Title
Manual Therapy Combined Breathing Training Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diaphragmatic Stretch Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breathing Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)
Time Frame
Change from baseline pain intensity up to 2 weeks
Secondary Outcome Measure Information:
Title
Functional Disability
Description
Neck disability index - Questionnaire
Time Frame
Change from baseline functional disability up to 2 weeks
Other Pre-specified Outcome Measures:
Title
Neck and Thoracic ROM
Description
Dual inclinometer
Time Frame
Change from baseline neck and thoracic ROM up to 2 weeks
Title
Neck Muscle Endurance
Description
Electromyography: EMG amplitude (root mean square, RMS) and frequency (median frequency, MF) on neck muscle
Time Frame
Change from baseline neck muscle endurance up to 2 weeks
Title
Neck Muscle Strength
Description
Micro FET2
Time Frame
Change from baseline neck muscle strength up to 2 weeks
Title
Chest Mobility
Description
Tape ruler
Time Frame
Change from baseline check mobility up to 2 weeks
Title
Diaphragmatic Changes
Description
Diaphragmatic thickness, mobility and strength using ultrasonography (M mode, B mode)
Time Frame
Change from baseline diaphragmatic chages up to 2 weeks
Title
Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
Description
Gas pressure gauge
Time Frame
Change from baseline MIP and MEP up to 2 weeks
Title
Lung Function
Description
Forced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) using Spirometer
Time Frame
Change from baseline lung function up to 2 weeks
Title
Heart Rate Variability
Description
Hand-held Electrocardiogram (CheckMyHeart Plus)
Time Frame
Change from baseline heart rate variability up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chronic or recurrent neck pain from upper cervical to T1 area Condition last for 3 months and above Exclusion Criteria: 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 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
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
State/Province
East District
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain

We'll reach out to this number within 24 hrs