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

NCT04664842 | Completed

• 1 other identifier: NCKU_Diaphragm
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

Ultrasonography; Diaphragm; Breathing exercise; Breathing dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Disability

  Change from baseline functional disability up to 2 weeks

Other Outcomes (8)

• Neck and Thoracic ROM

  Change from baseline neck and thoracic ROM up to 2 weeks

• Neck Muscle Endurance

  Change from baseline neck muscle endurance up to 2 weeks

• Neck Muscle Strength

  Change from baseline neck muscle strength up to 2 weeks

Study Arms (5)

Manual Therapy Group

EXPERIMENTAL

Other: Diaphragmatic Stretch Technique

Manual Control Group

SHAM COMPARATOR

Other: Diaphragmatic Stretch Technique

Breathing Training Group

EXPERIMENTAL

Other: Breathing Exercise Training

General Exercise Control Group

SHAM COMPARATOR

Other: Breathing Exercise Training

Manual Therapy Combined Breathing Training Group

EXPERIMENTAL

Other: Diaphragmatic Stretch Technique; Other: Breathing Exercise Training

Interventions

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.

Manual Control Group; Manual Therapy Combined Breathing Training Group; Manual Therapy Group

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.

Breathing Training Group; General Exercise Control Group; Manual Therapy Combined Breathing Training Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, East District, 701, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 41034882 DERIVED

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: December 11, 2020
• Study Start: August 1, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

TW (1)