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

Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention 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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: Diaphragmatic Stretch Technique; Other: Breathing Exercise Training

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • East District
    • Tainan, East District, Taiwan, 701
      • National Cheng Kung University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)	Change from baseline pain intensity up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disability	Neck disability index - Questionnaire	Change from baseline functional disability up to 2 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Breathing exercise; Ultrasonography; Diaphragm; Breathing dysfunction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: NCKU_Diaphragm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No