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

• ClinicalTrials.gov Identifier: NCT04664842
• Recruitment Status: Enrolling by invitation
• First Posted: December 11, 2020
• Last Update Posted: September 1, 2021
• Sponsor: National Cheng Kung University
• Information provided by (Responsible Party): YI-JU TSAI, National Cheng Kung University

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.

Condition or disease	Intervention/treatment	Phase
Chronic Neck Pain	Other: Diaphragmatic Stretch Technique; Other: Breathing Exercise Training	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain
• Actual Study Start Date: August 1, 2020
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Manual Therapy Group	Other: Diaphragmatic Stretch Technique; 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.
Sham Comparator: Manual Control Group	Other: Diaphragmatic Stretch Technique; 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.
Experimental: Breathing Training Group	Other: Breathing Exercise Training; 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.
Sham Comparator: General Exercise Control Group	Other: Breathing Exercise Training; 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.
Experimental: Manual Therapy Combined Breathing Training Group	Other: Diaphragmatic Stretch Technique; 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.; Other: Breathing Exercise Training; 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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Functional Disability [ Time Frame: Change from baseline functional disability up to 2 weeks ]
   Neck disability index - Questionnaire

Other Outcome Measures:

1. Neck and Thoracic ROM [ Time Frame: Change from baseline neck and thoracic ROM up to 2 weeks ]
   Dual inclinometer
2. Neck Muscle Endurance [ Time Frame: Change from baseline neck muscle endurance up to 2 weeks ]
   Electromyography: EMG amplitude (root mean square, RMS) and frequency (median frequency, MF) on neck muscle
3. Neck Muscle Strength [ Time Frame: Change from baseline neck muscle strength up to 2 weeks ]
   Micro FET2
4. Chest Mobility [ Time Frame: Change from baseline check mobility up to 2 weeks ]
   Tape ruler
5. Diaphragmatic Changes [ Time Frame: Change from baseline diaphragmatic chages up to 2 weeks ]
   Diaphragmatic thickness, mobility and strength using ultrasonography (M mode, B mode)
6. Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP) [ Time Frame: Change from baseline MIP and MEP up to 2 weeks ]
   Gas pressure gauge
7. Lung Function [ Time Frame: Change from baseline lung function up to 2 weeks ]
   Forced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) using Spirometer
8. Heart Rate Variability [ Time Frame: Change from baseline heart rate variability up to 2 weeks ]
   Hand-held Electrocardiogram (CheckMyHeart Plus)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Taiwan

National Cheng Kung University

Tainan, East District, Taiwan, 701

Sponsors and Collaborators

National Cheng Kung University

More Information

• Responsible Party: YI-JU TSAI, Associate Professor, National Cheng Kung University
• ClinicalTrials.gov Identifier: NCT04664842
• Other Study ID Numbers: NCKU_Diaphragm
• First Posted: December 11, 2020
• Last Update Posted: September 1, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by YI-JU TSAI, National Cheng Kung University:

Ultrasonography; Diaphragm; Breathing exercise; Breathing dysfunction

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations