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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04664842
Enrollment
126
Registered
2020-12-11
Start date
2020-08-01
Completion date
2021-09-15
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Neck Pain

Keywords

Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction

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.

Interventions

OTHERDiaphragmatic 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.

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.

Sponsors

National Cheng Kung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityChange from baseline pain intensity up to 2 weeksVisual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome)

Secondary

MeasureTime frameDescription
Functional DisabilityChange from baseline functional disability up to 2 weeksNeck disability index - Questionnaire

Other

MeasureTime frameDescription
Lung FunctionChange from baseline lung function up to 2 weeksForced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) using Spirometer
Heart Rate VariabilityChange from baseline heart rate variability up to 2 weeksHand-held Electrocardiogram (CheckMyHeart Plus)
Neck and Thoracic ROMChange from baseline neck and thoracic ROM up to 2 weeksDual inclinometer
Diaphragmatic ChangesChange from baseline diaphragmatic chages up to 2 weeksDiaphragmatic thickness, mobility and strength using ultrasonography (M mode, B mode)
Neck Muscle StrengthChange from baseline neck muscle strength up to 2 weeksMicro FET2
Chest MobilityChange from baseline check mobility up to 2 weeksTape ruler
Neck Muscle EnduranceChange from baseline neck muscle endurance up to 2 weeksElectromyography: EMG amplitude (root mean square, RMS) and frequency (median frequency, MF) on neck muscle
Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)Change from baseline MIP and MEP up to 2 weeksGas pressure gauge

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026