Cervical PainNCT04801875
Cervical Pain and Exercise in Musicians
A study testing Selected Exercise in people with Cervical Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Exercise training that is one of the effective treatment methods for cervical pain, is crucial in developing mobility and stability. Exercise training significantly reduces cervical pain as it advances postural alignment and neuromuscular coordination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Selected Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2018to 9 Jul 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being professional musicians
- Using violin or ney musical instruments
- Had non-specific cervical pain during 3 months
Who cannot join
- Had cervical surgery in the last 3 months, discogenic pain, radiculopathy, neurological or systemic disorders,
- Missing exercise training session more than 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Selected Exercise Program on Non-specific Cervical Pain in Ney and Violin Performers
Exercise training that is one of the effective treatment methods for cervical pain, is crucial in developing mobility and stability. Exercise training significantly reduces cervical pain as it advances postural alignment and neuromuscular coordination. In many single group studies on cervical pain in violin performers, it has been reported that the stabilization exercises have favorable consequences on pain relief and postural correction. But, there are no studies comparing ney and violin performers and analyzing the effectiveness of exercise training on non-specific cervical pain. The aim of this study is to search the effects of selected exercise training on pain, disability, range of motion, flexibility, strength and quality of life in ney and violin performers with non-specific cervical pain.
- Conditions
- Cervical Pain
- Being tested
- Selected Exercise
- Keywords
- Exercise, Cervical Pain, Disabilities, Musicians
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected ExerciseOther
The violin and ney groups performed a structured exercise training program 3 times a week for a total of 8 weeks. Adherence to the exercise training program was checked using a follow-up schedule to ensure regular participation of the musicians. The 8-week exercise training program was given with same physiotherapist under the same conditions. The every exercise session consisted of warm-up (3-5 min), main exercise (30-35 min) and cooling periods (3-5 min). The main exercise period was included ROM (10 min), stretching (5-7 min), isometric (5-10 min) and stabilization exercises (5 min).
| Study group | Role | What they receive |
|---|---|---|
| Violin Performers | Experimental | Violin performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment. Receives: Other: Selected Exercise |
| Ney Performers | Experimental | Ney performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment. Receives: Other: Selected Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale (VAS) was used to measure the severity of pain. In this scale, "0" indicates no pain, "10" indicates the highest value for perceived pain. Participants were asked to illustrate the intensity of the pain they felt on a material with a horizontal line of 10 cm and was recorded as VAS score.
Measured: 8 weeks
Functional Status
The Northwick Park Neck Pain Questionnaire (NPQ) was used to specify functional status. NPQ was developed to designate the level of disability in neck pain; It is a 9-item scale including neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities, and driving. It evaluates the severity, symptoms, duration of neck pain and disability in the activities specified in each item. Each of them consists of 5 items and is scored between 0-4 points. Neck pain total score consists of 36 points. If the patients are not driving, the total score is calculated over 32 points.
Measured: 8 weeks
Life Quality
Quality of life was evaluated with the SF-36 scale. The scale consists of 8 sub-parameters with a total of 36 items. These sub-parameters are listed as; physical function, physical role limitation, pain, general health, energy (vitality), social function, emotional role limitation and mental health.
Measured: 8 weeks
Secondary outcomes (4)
Muscle Strength
Muscle strength was measured with a digital muscle dynamometer (Jtech Commander Muscle Testing). Anterior and middle part of deltoid, serratus anterior, upper and middle part of trapezius, cervical flexor and extensor muscles were measured.
Measured: 8 weeks
Grip Strength
The grip strength was measured with a hand dynamometer (Baseline, Hydraulic Hand Dynamometer). Measurements were made in a sitting position, regardless of the right or left hand, with the elbow flexed at 90° and the arms in contact with the body without any abduction movement. In this position, Individuals were asked to squeeze their hand with maximum force and measurements were repeated for other arm.
Measured: 8 weeks
Range of Motion
Cervical Flexion, extension, rotation and lateral flexion were measured by using a universal goniometer. Head and trunk were held upright while participants were in a sitting position.
Measured: 8 weeks
Spinal Mobility
The jaw-sternum and jaw-wall distance were measured with a tape measure. Participants was asked to stand upright in an anatomical position while leaning against the wall. In this position, the distance of chin tip to wall and chin tip to the incisura jugularis were used.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Feb 2018
- Primary completion2 Jun 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was based on pre-test and post-test methods. Musicians who met inclusion criterion were assigned to violin and ney groups according to performing musical instrument.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801875
- Sponsor's protocol ID
- 2017/14
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan C, Driscoll T, Ackermann B. Development of a specific exercise programme for professional orchestral musicians. Inj Prev. 2013 Aug;19(4):257-63. doi: 10.1136/injuryprev-2012-040608. Epub 2012 Dec 4.
PubMed 23211353Kuo YL, Lee TH, Tsai YJ. Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain. Int J Environ Res Public Health. 2020 Jul 28;17(15):5430. doi: 10.3390/ijerph17155430.
PubMed 32731521Ackermann B, Driscoll T, Kenny DT. Musculoskeletal pain and injury in professional orchestral musicians in Australia. Med Probl Perform Art. 2012 Dec;27(4):181-7.
PubMed 23247873
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Selected Exercise Program on Non-specific Cervical Pain in Ney and Violin Performers
- ClinicalTrials.gov ID
- NCT04801875
- Acronym / sponsor ID
- 2017/14
- Conditions
- Cervical Pain
- Keywords
- Exercise, Cervical Pain, Disabilities, Musicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 17 Mar 2021 (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.
Exercise training that is one of the effective treatment methods for cervical pain, is crucial in developing mobility and stability. Exercise training significantly reduces cervical pain as it advances postural alignment and neuromuscular coordination. In many single group studies on cervical pain in violin performers, it has been reported that the stabilization exercises have favorable consequences on pain relief and postural correction. But, there are no studies comparing ney and violin performers and analyzing the effectiveness of exercise training on non-specific cervical pain. The aim of this study is to search the effects of selected exercise training on pain, disability, range of motion, flexibility, strength and quality of life in ney and violin performers with non-specific cervical pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was based on pre-test and post-test methods. Musicians who met inclusion criterion were assigned to violin and ney groups according to performing musical instrument.
| Arm | Type | Receives |
|---|---|---|
| Violin Performers | Experimental | Other: Selected ExerciseViolin performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment. |
| Ney Performers | Experimental | Other: Selected ExerciseNey performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being professional musicians
- Using violin or ney musical instruments
- Had non-specific cervical pain during 3 months
Key exclusion criteria (2 listed)
- Had cervical surgery in the last 3 months, discogenic pain, radiculopathy, neurological or systemic disorders,
- Missing exercise training session more than 2
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 |
|---|---|---|
| Selected ExerciseThe violin and ney groups performed a structured exercise training program 3 times a week for a total of 8 weeks. Adherence to the exercise training program was checked using a follow-up schedule to ensure regular participation of the musicians. The 8-week exercise training program was given with same physiotherapist under the same conditions. The every exercise session consisted of warm-up (3-5 min), main exercise (30-35 min) and cooling periods (3-5 min). The main exercise period was included ROM (10 min), stretching (5-7 min), isometric (5-10 min) and stabilization exercises (5 min). | Other | Ney Performers, Violin Performers |
Primary outcome
Pain intensity
Time frame: 8 weeks
Visual Analog Scale (VAS) was used to measure the severity of pain. In this scale, "0" indicates no pain, "10" indicates the highest value for perceived pain. Participants were asked to illustrate the intensity of the pain they felt on a material with a horizontal line of 10 cm and was recorded as VAS score.
Functional Status
Time frame: 8 weeks
The Northwick Park Neck Pain Questionnaire (NPQ) was used to specify functional status. NPQ was developed to designate the level of disability in neck pain; It is a 9-item scale including neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities, and driving. It evaluates the severity, symptoms, duration of neck pain and disability in the activities specified in each item. Each of them consists of 5 items and is scored between 0-4 points. Neck pain total score consists of 36 points. If the patients are not driving, the total score is calculated over 32 points.
Life Quality
Time frame: 8 weeks
Quality of life was evaluated with the SF-36 scale. The scale consists of 8 sub-parameters with a total of 36 items. These sub-parameters are listed as; physical function, physical role limitation, pain, general health, energy (vitality), social function, emotional role limitation and mental health.
4 secondary outcomes
Muscle Strength
Time frame: 8 weeks
Grip Strength
Time frame: 8 weeks
Range of Motion
Time frame: 8 weeks
Spinal Mobility
Time frame: 8 weeks
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 30 Mar 2021.
- Background: PubMed 23211353Chan C, Driscoll T, Ackermann B. Development of a specific exercise programme for professional orchestral musicians. Inj Prev. 2013 Aug;19(4):257-63. doi: 10.1136/injuryprev-2012-040608. Epub 2012 Dec 4.
- Background: PubMed 32731521Kuo YL, Lee TH, Tsai YJ. Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain. Int J Environ Res Public Health. 2020 Jul 28;17(15):5430. doi: 10.3390/ijerph17155430.
- Background: PubMed 23247873Ackermann B, Driscoll T, Kenny DT. Musculoskeletal pain and injury in professional orchestral musicians in Australia. Med Probl Perform Art. 2012 Dec;27(4):181-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected Exercise in people with Cervical Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 2 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 30 Mar 2021. 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 Turkey (Türkiye). 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?
Pain intensity (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801875, which also lists 3 linked publications.
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 30 Mar 2021.