Neck PainNCT04051593
Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain
A study testing Cervical stabilization exercise in people with Neck Pain, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervical stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neck Pain
- Being tested
- Cervical stabilization exercise
- Keywords
- cervical stabilization exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical stabilization exerciseOther
The participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Exercise Receives: Other: Cervical stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported neck pain: Numeric Rating Scale
Measured by the Numeric Rating Scale (min 0-max 10, better outcome 0 worst outcome 10)
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Changes in neck disability
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%)
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Secondary outcomes (4)
Changes in deep neck flexors function
Measured by the craniocervical flexion test with a pressure biofeedback unit (higher pressure represents better outcome)
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Changes in cervical muscle endurance
Measured using a stopwatch for the successful time holding the head in cervical flexion and extension positions (longer time represent better outcome)
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Changes in cervical joint position sense
Measured by the cervcal joint reposition error with a laser pointer (short distance represent better outcome)
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Changes in upper body posture
Evaluated by the photographic method
Measured: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start12 Jun 2018
- Primary completion1 Sep 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI-JU TSAI, National Cheng Kung University
- Investigators
- Yi-Ju Tsai, Ph.D., Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051593
- Sponsor's protocol ID
- NationalCheng-KungU
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Stabilization Exercises Improved Pain, Disability, and Physical Impairments in University Violinists With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT04051593
- Acronym / sponsor ID
- NationalCheng-KungU
- Conditions
- Neck Pain
- Keywords
- cervical stabilization exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Cervical stabilization exerciseExercise |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical stabilization exerciseThe participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks. | Other | Treatment |
Primary outcome
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)
Measured by the Numeric Rating Scale (min 0-max 10, better outcome 0 worst outcome 10)
Changes in neck disability
Time frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
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%)
4 secondary outcomes
Changes in deep neck flexors function
Time frame: 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)
Changes in cervical joint position sense
Time frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Changes in upper body posture
Time frame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Ju Tsai, Ph.D. principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical stabilization exercise in people with Neck Pain, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.