Non Specific Chronic Neck PainNCT07048093
Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness
A study testing Exercise in people with Non Specific Chronic Neck Pain, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine whether relaxation exercises performed before cranio-cervical flexion can reduce superficial neck muscle activation (specifically sternocleidomastoid and upper trapezius) in individuals with neck pain. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Non Specific Chronic Neck Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knowledge of Turkish
- Chronic (at least three months) neck pain
- Neck pain level of 4 or higher on a numerical pain scale
Who cannot join
- Neck pain caused by a tumor, trauma, or rheumatic disease
- History of surgery involving the head, neck, shoulder, or thoracic region
- Root compression
- Regular use of painkillers due to another illness
- Another illness severe enough to interfere with work
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Faculty of Health Sciences
Balıkesir, Balıkesir, 10145
Sibel Ergun, Professor, +902666121400 ext. 151330, sibel.ergun@balikesir.edu.tr
Meral Sertel, Professor, +902666121400 ext. 151318, meral.sertel@balikesir.edu.tr
About this study
The goal of this observational study is to determine whether relaxation exercises performed before cranio-cervical flexion can reduce superficial neck muscle activation (specifically sternocleidomastoid and upper trapezius) in individuals with neck pain.
The main questions it aims to answer are:
Read more
- Does performing relaxation exercises prior to cranio-cervical flexion reduce sternocleidomastoid (SCM) muscle activation?
- Does it reduce upper trapezius muscle activation during the standing?
Researchers will compare the group performing relaxation exercises before cranio-cervical flexion to the group performing only cranio-cervical flexion to see if there is a measurable difference in superficial neck muscle activation.
Participants will:
- Perform cranio-cervical flexion exercises.
- Perform relaxation exercises prior to the cranio-cervical flexion (intervention group only).
- Undergo surface EMG measurements to assess muscle activity.
- Conditions
- Non Specific Chronic Neck Pain
- Being tested
- Exercise, Sham (No Treatment)
- Keywords
- Relaxation Exercise, craniocervical flexion, upper trapezius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Average of 10 minutes relaxation exercises guided with a standard audio record based on reciprocal and autogenic muscle inhibition, proprioceptive training and postural training.
Sham (No Treatment)Other
This group take no treatment between actual before and after measurements.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Exercises Group | Experimental | This group will do relaxation exercises based on reciprocal inhibition, autogenic inhibition, proprioceptive training and postural training. Receives: Other: Exercise |
| Just Lie Back Group | Sham comparator | This group do nothing but just lie back before and after actual measurements. Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
On the numerical pain scale, the patient will be asked, "0 means no pain at all, 10 means unbearable pain, representing the worst pain/unbearable pain you have ever experienced. On a scale of 0 to 10, how would you rate your pain?"
Measured: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention or sham intervention (Day 1)
Turkish Version of Core Outcome Measure Index for Neck Pain
The first question consists of two 10-point numerical pain scales that ask about neck and arm-shoulder pain. Whichever of these two questions receives a higher response is used. The other five questions are five point Likert-type response questions. The six items cover five dimensions: pain intensity (neck and arm/shoulder pain), neck-related function, symptom-specific well-being, overall quality of life, and disability (social and work). The total score is calculated by taking the average of all responses. To form the Core Outcome Measure Index summary score, each of the dimension scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status.
Measured: At enrollment (pre-intervention)
EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver
EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver standardized with Stabilizer Pressure Biofeedback Device
Measured: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)
EMG Activation Level of Upper Trapezius Muscle During Standing Still
EMG Activation Level of Upper Trapezius Muscle During Standing Still
Measured: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start22 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non Specific Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Berberoğlu, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048093
- Sponsor's protocol ID
- G.O. 2024/153
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This ethics committee has not yet established a data policy regarding open data. Otherwise, I would share it once it has been anonymised. I am still discussing this matter with the committee.
Publications
Rota E, Evangelista A, Ceccarelli M, Ferrero L, Milani C, Ugolini A, Mongini F. Efficacy of a workplace relaxation exercise program on muscle tenderness in a working community with headache and neck pain: a longitudinal, controlled study. Eur J Phys Rehabil Med. 2016 Aug;52(4):457-65. Epub 2016 Jan 8.
PubMed 26745361Lee BK, Seo DK. The Importance of Optimal Gaze Direction on Deep Neck Flexor Activation in Chronic Neck Pain. Healthcare (Basel). 2020 Nov 1;8(4):449. doi: 10.3390/healthcare8040449.
PubMed 33139645Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
PubMed 34980079Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.
PubMed 19632880
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness
- ClinicalTrials.gov ID
- NCT07048093
- Acronym / sponsor ID
- G.O. 2024/153
- Conditions
- Non Specific Chronic Neck Pain
- Keywords
- Relaxation Exercise, craniocervical flexion, upper trapezius
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Jul 2025 (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 goal of this observational study is to determine whether relaxation exercises performed before cranio-cervical flexion can reduce superficial neck muscle activation (specifically sternocleidomastoid and upper trapezius) in individuals with neck pain.
The main questions it aims to answer are:
- Does performing relaxation exercises prior to cranio-cervical flexion reduce sternocleidomastoid (SCM) muscle activation?
- Does it reduce upper trapezius muscle activation during the standing?
Researchers will compare the group performing relaxation exercises before cranio-cervical flexion to the group performing only cranio-cervical flexion to see if there is a measurable difference in superficial neck muscle activation.
Participants will:
- Perform cranio-cervical flexion exercises.
- Perform relaxation exercises prior to the cranio-cervical flexion (intervention group only).
- Undergo surface EMG measurements to assess muscle activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Exercises Group | Experimental | Other: ExerciseThis group will do relaxation exercises based on reciprocal inhibition, autogenic inhibition, proprioceptive training and postural training. |
| Just Lie Back Group | Sham comparator | Other: Sham (No Treatment)This group do nothing but just lie back before and after actual measurements. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knowledge of Turkish
- Chronic (at least three months) neck pain
- Neck pain level of 4 or higher on a numerical pain scale
Key exclusion criteria (5 listed)
- Neck pain caused by a tumor, trauma, or rheumatic disease
- History of surgery involving the head, neck, shoulder, or thoracic region
- Root compression
- Regular use of painkillers due to another illness
- Another illness severe enough to interfere with work
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 |
|---|---|---|
| ExerciseAverage of 10 minutes relaxation exercises guided with a standard audio record based on reciprocal and autogenic muscle inhibition, proprioceptive training and postural training. | Other | Relaxation Exercises Group |
| Sham (No Treatment)This group take no treatment between actual before and after measurements. | Other | Just Lie Back Group |
Primary outcome
Numerical Pain Rating Scale
Time frame: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention or sham intervention (Day 1)
On the numerical pain scale, the patient will be asked, "0 means no pain at all, 10 means unbearable pain, representing the worst pain/unbearable pain you have ever experienced. On a scale of 0 to 10, how would you rate your pain?"
Turkish Version of Core Outcome Measure Index for Neck Pain
Time frame: At enrollment (pre-intervention)
The first question consists of two 10-point numerical pain scales that ask about neck and arm-shoulder pain. Whichever of these two questions receives a higher response is used. The other five questions are five point Likert-type response questions. The six items cover five dimensions: pain intensity (neck and arm/shoulder pain), neck-related function, symptom-specific well-being, overall quality of life, and disability (social and work). The total score is calculated by taking the average of all responses. To form the Core Outcome Measure Index summary score, each of the dimension scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status.
EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver
Time frame: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)
EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver standardized with Stabilizer Pressure Biofeedback Device
EMG Activation Level of Upper Trapezius Muscle During Standing Still
Time frame: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)
EMG Activation Level of Upper Trapezius Muscle During Standing Still
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 26745361Rota E, Evangelista A, Ceccarelli M, Ferrero L, Milani C, Ugolini A, Mongini F. Efficacy of a workplace relaxation exercise program on muscle tenderness in a working community with headache and neck pain: a longitudinal, controlled study. Eur J Phys Rehabil Med. 2016 Aug;52(4):457-65. Epub 2016 Jan 8.
- Background: PubMed 33139645Lee BK, Seo DK. The Importance of Optimal Gaze Direction on Deep Neck Flexor Activation in Chronic Neck Pain. Healthcare (Basel). 2020 Nov 1;8(4):449. doi: 10.3390/healthcare8040449.
- Background: PubMed 34980079Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
- Background: PubMed 19632880Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.
- Individual participant dataSharing planned: Undecided. This ethics committee has not yet established a data policy regarding open data. Otherwise, I would share it once it has been anonymised. I am still discussing this matter with the committee.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Non Specific Chronic Neck Pain, run by Balikesir 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 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: opening soon, as of the sponsor's last update on 22 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Utku Berberoğlu, PhD (+902666121400 ext. 151315, utku.berber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: At enrollment (pre-intervention) and immediately after the relaxation exercise intervention or sham intervention (Day 1)). The study lists 4 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 NCT07048093, which also lists 4 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 22 Sep 2025.