- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051593
Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain
September 19, 2023 updated by: YI-JU TSAI, National Cheng Kung University
Cervical Stabilization Exercises Improved Pain, Disability, and Physical Impairments in University Violinists With Nonspecific Neck Pain
The purpose of this study is to examine the influence of a 6-week cervical stabilization exercise program in university violin players with chronic nonspecific neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan City, Taiwan, 701
- National Cheng Kung University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- duration of playing the instrument longer than 5 years
- practicing the violin more than 5 hours/week
- constant neck pain for more than 3 months or at least 2 pain episodes in the last 3 months
Exclusion Criteria:
- previous surgery in the neck and shoulder regions
- current participation in a structured exercises program
- current treatment for neck and shoulder pain
- red flags suggesting of cancer, infection, vascular insufficiency, and etc. during history taking
- neurological symptoms of the upper extremities during screening tests (e.g. Spurling test and upper limb tension tests)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Exercise
|
The participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-reported neck pain: Numeric Rating Scale
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Measured by the Numeric Rating Scale (min 0-max 10, better outcome 0 worst outcome 10)
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Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
|
Changes in neck disability
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Measured by the Neck Disability Index (10-item questionnaire, each item scored from 0 to 5, result expressed as percentage, better outcome 0 worst outcome 100%)
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Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in deep neck flexors function
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
Measured by the craniocervical flexion test with a pressure biofeedback unit (higher pressure represents better outcome)
|
Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
|
Changes in cervical muscle endurance
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Measured using a stopwatch for the successful time holding the head in cervical flexion and extension positions (longer time represent better outcome)
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Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
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Changes in cervical joint position sense
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Measured by the cervcal joint reposition error with a laser pointer (short distance represent better outcome)
|
Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
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Changes in upper body posture
Time Frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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Evaluated by the photographic method
|
Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yi-Ju Tsai, Ph.D., National Cheng Kung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2018
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
August 3, 2019
First Submitted That Met QC Criteria
August 8, 2019
First Posted (Actual)
August 9, 2019
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NationalCheng-KungU (Registry Identifier: National Cheng-Kung University Hospital Clinical Trial Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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