Cervical Pain and Exercise in Musicians

March 25, 2021 updated by: Serkan Usgu, Hasan Kalyoncu University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Gaziantep, Turkey, 27144
        • Hasan Kalyoncu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being professional musicians
  • Using violin or ney musical instruments
  • Had non-specific cervical pain during 3 months

Exclusion Criteria:

  • Had cervical surgery in the last 3 months, discogenic pain, radiculopathy, neurological or systemic disorders,
  • Missing exercise training session more than 2

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Violin Performers
Violin performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment.
Other: Selected Exercise
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).
Experimental: Ney Performers
Ney performers received three 40-45 minute exercise sessions each week for eight weeks. The selected exercise program designed to correct postural alignment.
Other: Selected Exercise
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: 8 weeks
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.
8 weeks
Grip Strength
Time Frame: 8 weeks
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.
8 weeks
Range of Motion
Time Frame: 8 weeks
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.
8 weeks
Spinal Mobility
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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