Skip to main content
OpenTrials
Completed

NCT Number: NCT04664842

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Neck Pain

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, East District, 701, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragmatic Stretch Technique

Other

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.

Breathing Exercise Training

Other

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 outcomes

  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 outcomes

  1. Functional Disability

    Time frame: Change from baseline functional disability up to 2 weeks

    Neck disability index - Questionnaire

Other outcomes

  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)

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.