NCT05529641

Brief Summary

With increasing usage of electronic devices and sedentary lifestyle, chronic neck pain has become a more prevalent musculoskeletal disorder around the world. Many impairments have been identified in people with chronic neck pain including pain, muscle weakness, proprioceptive deficits and altered breathing pattern. Diaphragm is the key muscle for inspiration and also plays an important role in spinal stability. Previous studies have found that diaphragm functions are related to the stability of the lumbar spine through the fascial, neural and visceral systems. Diaphragmatic resistance training thus could have some positive effects on reducing pain and disability in people with low back pain. However, to date how diaphragmatic resistance training would affect chronic neck pain is still unknown. Therefore, the purpose of this study is to investigate the effects of diaphragmatic resistance training on pain, disability and movement quality in people with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

September 2, 2022

Last Update Submit

November 27, 2025

Conditions

Keywords

Chronic neck painKinematicsDiaphragmDiaphragmatic resistance trainingStabilization exercise

Outcome Measures

Primary Outcomes (4)

  • Pain intensity using Visual Analog Scale (VAS)

    Visual Analog Scale (VAS), a self-reported scale, provides 100 mm line that participants will mark the maximal and averaged pain intensity within past 7 days. The length of the line that participants marked would be the intensity of pain. The minimal value will be 0 mm and maximal value will be 100 mm. The longer the length indicates the higher intensity of pain.

    Changes from baseline to 6 weeks when participants finish the intervention.

  • Disability using Neck Disability Index (NDI)

    Neck Disability Index (NDI), a self-reported scale, contains 10 sessions of question to evaluating how severe that functional activity level was affected by neck pain. Each session scores ranging from 0 to 5. Total score range from 0 to 50. The higher the score indicates more disability level.

    Changes from baseline to 6 weeks when participants finish the intervention.

  • Cervical kinematics

    Using optical motion analysis system to assess cervical kinematics for movement quality.

    Changes from baseline to 6 weeks when participants finish the intervention.

  • Muscle activation

    Using surface electromyogram to assess muscle activation pattern.

    Changes from baseline to 6 weeks when participants finish the intervention.

Study Arms (2)

Combined diaphragmatic resistance training and cervical stabilization exercise group

EXPERIMENTAL

Participants in this group will receive supervised cervical stabilization exercise and diaphragmatic resistance training as home grogram.

Other: Diaphragmatic resistance trainingOther: Cervical stabilization exercise

Cervical stabilization exercise group

ACTIVE COMPARATOR

Participants in this group will only receive supervised cervical stabilization exercise.

Other: Cervical stabilization exercise

Interventions

6 weeks home exercise of diaphragmatic resistance training will be emphasized.

Combined diaphragmatic resistance training and cervical stabilization exercise group

Participants will finish 6 weeks supervised cervical stabilization exercise in person by physical therapist. Dissociated movement and movement control will be emphasized during cervical stabilization exercise.

Cervical stabilization exercise groupCombined diaphragmatic resistance training and cervical stabilization exercise group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain between nuchal line to T1 spinous process lasting over 3 months.

You may not qualify if:

  • First onset acute neck pain.
  • Surgery history.
  • Neurological symptoms.
  • Respiratory, psychiatric and neuromuscular disorders.
  • Smoking, pregnant, cancer.
  • Severe anemia or diabetes.
  • Core exercise in past 12 months.
  • Spine or chest deformity.
  • Body mass index (BMI) \> 30 kg/m/m.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Neck PainRespiratory Aspiration

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Design

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

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

December 9, 2022

Primary Completion

May 31, 2025

Study Completion

August 31, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations