Myofascial Pain SyndromeNCT05225571
The Relationship of Cervical Sagittal Parameters With Pain and Disability in Cervical Myofascial Pain Syndrome
An observational study of Myofascial Pain Syndrome and Neck Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, Bournemouth neck questionnaire and cervical range of motion will be measured and evaluated. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Myofascial Pain Syndrome, Neck Pain, Neck Disorder
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 10 Oct 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 64 years
- All sexes
- Adult
Study population: The participants who aged 18-64 Years , and diagnosed as cervical myofascial pain syndrome.
Who may be able to join
- Age at 18-64 years
- Neck pain due to myofascial pain syndrome for more than 3 months
- Presence of lateral cervical radiograph taken in neutral position in the last 3 months
- Visible lower border of T1 vertebra on lateral radiographs
- Absence of other spinal pathologies such as underlying scoliosis, cervical disc herniation, spondylolysis, spondylolisthesis
Who cannot join
- Presence of an organic pathology that will cause neck pain
- Inability to see the lower border of the T1 vertebra on lateral cervical radiographs and the radiographs not taken in neutral position
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman TRH
Istanbul, Kucukcekmece, 34303
About this study
Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, Bournemouth neck questionnaire and cervical range of motion will be measured and evaluated.
Read the detailed description
It is an observational, cross-sectional study. Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome, who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital with neck pain for more than 3 months will be included. The pain level of the participants will be evaluated with the numerical pain rating scale, the cervical range of motion and the disability level with the Bournemouth neck questionnaire. C0-2 cervical lordosis angle, C2-C7 cervical lordosis angle, cervical sagittal vertical axis (cSVA), T1 slop, T1 slop - cervical lordosis angle (TS-CL), cervical tilt, thoracic inlet angle (TIA) and Cranial tilt measurement will be performed by using Surgimap software program. The relationship between the level of pain and disability, and cervical sagittal parameters will be evaluated.
- Conditions
- Myofascial Pain Syndrome, Neck Pain, Neck Disorder
- Being tested
- no intervention
- Keywords
- sagittal alignment, myofascial pain syndrome, neck disability, pain intensity
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
there is no any intervention in this study. it is an observational and cross-sectional study.
| Study group | Role | What they receive |
|---|---|---|
| cervical myofascial pain syndrome | The participants who diagnosed as cervical myofascial pain syndrome aged 18-64 years. The pain must last at least 3 months. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numerical rating scale)
The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the child rates the pain from 0 (no pain) to 10 (worst pain)
Measured: 1 day
cervical range of motion (degree)
cervical flexion, extension, lateral flexion and rotation angles are actively evaluated.
Measured: 1 day
Bournemouth Neck Questionnaire
Adapted from the Bournemouth Low Back Pain questionnaire developed by Bolton and Humphreys in 2002. The Bournemouth Neck Pain Questionnaire consists of 7 questions in total. Each question scores between 0 and 10. Although the highest score is 70, a high score indicates a high level of disability.
Measured: 1 day
cervical sagittal parameters
Parameters to be checked in cervical lateral radiograph; C0-2 and C2-7 lordosis, T1 slope, c2-7 sagittal vertical axis, TS-CL, servical tilt and cranial tilt.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Sep 2021
- Primary completion10 Jul 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merve Damla Korkmaz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225571
- Sponsor's protocol ID
- KAEK/2021.05.146
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Cervical Sagittal Parameters With Pain and Disability in Cervical Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05225571
- Acronym / sponsor ID
- KAEK/2021.05.146
- Conditions
- Myofascial Pain Syndrome, Neck Pain, Neck Disorder
- Keywords
- sagittal alignment, myofascial pain syndrome, neck disability, pain intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 4 Feb 2022 (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.
Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, Bournemouth neck questionnaire and cervical range of motion will be measured and evaluated.
Detailed description
It is an observational, cross-sectional study. Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome, who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital with neck pain for more than 3 months will be included. The pain level of the participants will be evaluated with the numerical pain rating scale, the cervical range of motion and the disability level with the Bournemouth neck questionnaire. C0-2 cervical lordosis angle, C2-C7 cervical lordosis angle, cervical sagittal vertical axis (cSVA), T1 slop, T1 slop - cervical lordosis angle (TS-CL), cervical tilt, thoracic inlet angle (TIA) and Cranial tilt measurement will be performed by using Surgimap software program. The relationship between the level of pain and disability, and cervical sagittal parameters will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical myofascial pain syndrome | – | Other: no interventionThe participants who diagnosed as cervical myofascial pain syndrome aged 18-64 years. The pain must last at least 3 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participants who aged 18-64 Years , and diagnosed as cervical myofascial pain syndrome.
Key inclusion criteria (5 listed)
- Age at 18-64 years
- Neck pain due to myofascial pain syndrome for more than 3 months
- Presence of lateral cervical radiograph taken in neutral position in the last 3 months
- Visible lower border of T1 vertebra on lateral radiographs
- Absence of other spinal pathologies such as underlying scoliosis, cervical disc herniation, spondylolysis, spondylolisthesis
Key exclusion criteria (2 listed)
- Presence of an organic pathology that will cause neck pain
- Inability to see the lower border of the T1 vertebra on lateral cervical radiographs and the radiographs not taken in neutral position
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 |
|---|---|---|
| no interventionthere is no any intervention in this study. it is an observational and cross-sectional study. | Other | cervical myofascial pain syndrome |
Primary outcome
NRS (Numerical rating scale)
Time frame: 1 day
The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the child rates the pain from 0 (no pain) to 10 (worst pain)
cervical range of motion (degree)
Time frame: 1 day
cervical flexion, extension, lateral flexion and rotation angles are actively evaluated.
Bournemouth Neck Questionnaire
Time frame: 1 day
Adapted from the Bournemouth Low Back Pain questionnaire developed by Bolton and Humphreys in 2002. The Bournemouth Neck Pain Questionnaire consists of 7 questions in total. Each question scores between 0 and 10. Although the highest score is 70, a high score indicates a high level of disability.
cervical sagittal parameters
Time frame: 1 day
Parameters to be checked in cervical lateral radiograph; C0-2 and C2-7 lordosis, T1 slope, c2-7 sagittal vertical axis, TS-CL, servical tilt and cranial tilt.
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 27 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Merve Damla Korkmaz principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain Syndrome and Neck Pain, run by Kanuni Sultan Suleyman Training and Research Hospital 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 5 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 27 Dec 2022. 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?
NRS (Numerical rating scale) (time frame: 1 day). 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?
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 27 Dec 2022.