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

NCT ID: NCT04664842

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-09-15

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.

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Manual Therapy Group

Group Type: EXPERIMENTAL

Diaphragmatic Stretch Technique

Intervention Type: 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.

Manual Control Group

Group Type: SHAM_COMPARATOR

Diaphragmatic Stretch Technique

Intervention Type: 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 Training Group

Group Type: EXPERIMENTAL

Breathing Exercise Training

Intervention Type: 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.

General Exercise Control Group

Group Type: SHAM_COMPARATOR

Breathing Exercise Training

Intervention Type: 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.

Manual Therapy Combined Breathing Training Group

Group Type: EXPERIMENTAL

Diaphragmatic Stretch Technique

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

YI-JU TSAI

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cheng Kung University

Tainan City, East District, Taiwan

Countries

Taiwan

References

Cheng KC, Hii EYX, Lin YN, Kuo YL, Tsai YJ. Effects of manual diaphragm release on pain, disability and diaphragm function in patients with chronic neck pain: a pilot randomized controlled trial. BMC Complement Med Ther. 2025 Oct 1;25(1):349. doi: 10.1186/s12906-025-05090-8.

Reference Type: DERIVED

PMID: 41034882 (View on PubMed)

Other Identifiers

NCKU_Diaphragm

Identifier Type: -

Identifier Source: org_study_id