Myofascial Pain Syndrome, DiffuseNCT06707675
Chronotype and Myofascial Pain Syndrome,
An observational study of Myofascial Pain Syndrome, Diffuse, run by Afyonkarahisar Health Sciences University.
Trial summary
The aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome, Diffuse
- What is being tested?
- Assessment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 who applied to Afyonkarahisar Health Sciences University (AFSU) Physical Medicine and Rehabilitation Polyclinic and who have had neck and back pain complaints for at least 3 months were diagnosed with myofascial pain syndrome through anamnesis and physical examination.
Who may be able to join
- neck-back pain for at least 3 months
- diagnosis of myofascial pain syndrome by anamnesis and physical examination
Who cannot join
- Cervical Radiculopathy/Myelopathy
- Recent injection or physical therapy within the last 3 months
- Neck and shoulder surgery
- Neurological and inflammatory diseases
- Pregnancy
- Malignancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chronotype and Quality of Life in Patients with Myofascial Pain Syndrome, a Cross-Sectional Study
The aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life.
Read the detailed description
Myofascial pain syndrome (MPS) is defined as sensory, motor, and autonomic symptoms caused by myofascial trigger points. Trigger points are defined as tender points in discrete taut bands of stiffened muscle that cause local and referred pain, among other symptoms. The mechanical and psychological stress of the muscle can activate trigger points and cause pain over a wide area. MyofascialPainSyndrome (MPS) is considered one of the most common chronic musculoskeletal pains. Various studies have shown that it is often associated with depression and anxiety. It is important to focus on modifiable biopsychosocial factors, while paying attention to aspects that cannot be changed, such as attitudes, neuroticism, and trait anxiety, which are known to be somewhat stable over time. Knowing these factors is necessary to improve patients' quality of life and regain their functions.
Pain in patients with MAS can cause sleep disorders such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 70-80% of patients with MAS experience sleep disorders. Patients with insomnia, especially those living in urban affluent areas, are at risk of developing MAS later in life. Morning-evening preference is an inter-individual difference, also known as diurnal or circadian preference.
The circadian rhythm is controlled by the endogenous circadian clock, which has a genetic basis and is affected by exogenous factors. Due to these individual differences, individuals' energy levels during the day vary so much that people prefer to be active at different times of the day. Morning Type individuals prefer to be active early in the day, while evening type individuals prefer to be active later in the day. Individuals who are between these types and morning or evening preference are called intermediate types. Morning preference is affected by biological factors (e.g., body temperature, cortisol, melatonin), technological and social factors (e.g., electronic media, lighting, TV screens, daily life activities), and environmental factors (e.g., climate, latitude, longitude). In addition, morning preference is related to personality, health, eating habits and psychological well-being. Morning people are more conscientious and more prone to healthy behaviors. On the other hand, evening preference can lead to behavioral problems (e.g., depression, loneliness), personality disorders (substance abuse, eating disorders, internet addiction, daytime sleepiness) and poor academic performance. A study in which 1548 people with fibromyalgia (FMS) were assessed with an online survey that included questions about sleep quality, well-being, pain, chronotype and FMS showed that late chronotypes were more affected by fibromyalgia.
Another study investigating the relationships between chronotypes and musculoskeletal pain showed that evening and intermediate chronotypes were associated with musculoskeletal pain, but mental distress, insomnia, and comorbidities also played a role in these relationships. The aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life.
- Conditions
- Myofascial Pain Syndrome, Diffuse
- Being tested
- Assessment
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
The patients' demographic information, weight and height measurements, occupational activities and desk work time, daily screen usage time, pain intensity (with VAS), cervical joint range of motion examination, pain threshold (with pressure algometer), functional status (with Neck Pain Disability Scale), sleep quality (with Pittsburgh Sleep Quality Scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspects of pain (with Pain Catastrophizing Scale) will be evaluated. The patients' chronotype preferences will be evaluated with Morningness Eveningness Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| MPS | Patients aged between 18-65 who applied to the AFSÜ PTR Polyclinic and had complaints of neck and back pain for at least 3 months and were diagnosed with myofascial pain syndrome based on anamnesis and physical examination. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
The Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at 0, and that the most severe pain they have ever felt at 100, and the patient is asked to put a mark on the point corresponding to their pain.
Measured: "Baseline"
Pressure Algometry Measurements: (kg/cm2)
Algometry measurements will be measured with the Baseline Push Pull Force Gauge ® (Fabrication Enterprises, Inc. PO Box 1500, White Plains, New York 10602, USA) algometry device from the painful trigger point area with the patient in a sitting position.
Pressure will be applied slowly until the participant first feels pain and responds by saying "stop" and three measurements will be taken with a 30-second interval after each measurement and the average of the three measurements will be recorded as the final value.
Measured: "Baseline"
Cervical joint range of motion
Active passive ROM (flexion, extension, right-left) flexion and rotation) of the cervical joint will be measured.
Measured: "Baseline"
Morningness Eveningness Questionnaire
One of the most widely used tools to assess sleep chronotype preferences. This 19-item screening questionnaire has a rating range of 16 to 86.
The scoring results are classified as follows: evening types with scores between 16 and 41, morning types with scores between 59 and 86, and no types with scores between 42 and 58.
The Turkish version has been shown to have good validity and reliability
Measured: "Baseline"
Secondary outcomes (5)
Neck Pain Disability Scale
The questionnaire consists of 20 items and measurements. It includes questions about neck movements, pain intensity, the effect of neck pain on mood, and daily living activities. Each section is scored on a 0-5 rating scale and the total score ranges from 0-100. The Turkish version of this scale was found to be valid and reliable.
Measured: "Baseline"
Pittsburg Sleep Quality Index (PSQI)
PSQI consists of 24 questions in total. 19 of these questions are self-assessment questions. The remaining 5 questions are questions answered by the individual's roommate or spouse, if any. Question 19 on the scale asks whether the participant has a roommate or spouse. The answer to this question is not included in the score calculation. The first 18 questions answered by the participant are used in calculating the total PSQI score and component scores.
The 18 questions answered by the participant provide information about 7 components: sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime sleep dysfunction (component 7). Each component is evaluated on a scale of 0-3 points. The sum of these 7 component scores gives the total PSQI score. The total PSQI score varies between 0-21. The sleep qual
Measured: "Baseline"
Beck Depression Anxiety Inventory
The Beck Depression Inventory is a self-assessment scale consisting of 21 items. Each item is scored between 0 and 3, the highest score that can be obtained from the scale is 63, and the lowest score is 0. A high score from the scale indicates that the severity or level of depression is high.
Measured: "Baseline"
The Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a 13-item self-report inventory using a 5-point Likert scale (0-4) developed by Sullivan et al. to measure the extent to which people catastrophize in response to pain. The original scale consists of three subfactors called helplessness, magnification, and rumination.
Measured: "Baseline"
SF-12
SF-12 is an easy-to-apply questionnaire with proven reliability and validity, obtained by shortening and simplifying SF-36. It is used to assess the two main components of general health status, physical and mental health. Consisting of twelve questions, SF-12 has mental and physical component scores. High scores indicate good health status.
Measured: "Baseline"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome, DiffuseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707675
- Sponsor's protocol ID
- SAMAS
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronotype and Quality of Life in Patients with Myofascial Pain Syndrome, a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06707675
- Acronym / sponsor ID
- SAMAS
- Conditions
- Myofascial Pain Syndrome, Diffuse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 27 Nov 2024 (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 aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life.
Detailed description
Myofascial pain syndrome (MPS) is defined as sensory, motor, and autonomic symptoms caused by myofascial trigger points. Trigger points are defined as tender points in discrete taut bands of stiffened muscle that cause local and referred pain, among other symptoms. The mechanical and psychological stress of the muscle can activate trigger points and cause pain over a wide area. MyofascialPainSyndrome (MPS) is considered one of the most common chronic musculoskeletal pains. Various studies have shown that it is often associated with depression and anxiety. It is important to focus on modifiable biopsychosocial factors, while paying attention to aspects that cannot be changed, such as attitudes, neuroticism, and trait anxiety, which are known to be somewhat stable over time. Knowing these factors is necessary to improve patients' quality of life and regain their functions.
Pain in patients with MAS can cause sleep disorders such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 70-80% of patients with MAS experience sleep disorders. Patients with insomnia, especially those living in urban affluent areas, are at risk of developing MAS later in life. Morning-evening preference is an inter-individual difference, also known as diurnal or circadian preference.
The circadian rhythm is controlled by the endogenous circadian clock, which has a genetic basis and is affected by exogenous factors. Due to these individual differences, individuals' energy levels during the day vary so much that people prefer to be active at different times of the day. Morning Type individuals prefer to be active early in the day, while evening type individuals prefer to be active later in the day. Individuals who are between these types and morning or evening preference are called intermediate types. Morning preference is affected by biological factors (e.g., body temperature, cortisol, melatonin), technological and social factors (e.g., electronic media, lighting, TV screens, daily life activities), and environmental factors (e.g., climate, latitude, longitude). In addition, morning preference is related to personality, health, eating habits and psychological well-being. Morning people are more conscientious and more prone to healthy behaviors. On the other hand, evening preference can lead to behavioral problems (e.g., depression, loneliness), personality disorders (substance abuse, eating disorders, internet addiction, daytime sleepiness) and poor academic performance. A study in which 1548 people with fibromyalgia (FMS) were assessed with an online survey that included questions about sleep quality, well-being, pain, chronotype and FMS showed that late chronotypes were more affected by fibromyalgia.
Another study investigating the relationships between chronotypes and musculoskeletal pain showed that evening and intermediate chronotypes were associated with musculoskeletal pain, but mental distress, insomnia, and comorbidities also played a role in these relationships. The aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPS | – | Other: AssessmentPatients aged between 18-65 who applied to the AFSÜ PTR Polyclinic and had complaints of neck and back pain for at least 3 months and were diagnosed with myofascial pain syndrome based on anamnesis and physical examination. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 who applied to Afyonkarahisar Health Sciences University (AFSU) Physical Medicine and Rehabilitation Polyclinic and who have had neck and back pain complaints for at least 3 months were diagnosed with myofascial pain syndrome through anamnesis and physical examination.
Key inclusion criteria (2 listed)
- neck-back pain for at least 3 months
- diagnosis of myofascial pain syndrome by anamnesis and physical examination
Key exclusion criteria (6 listed)
- Cervical Radiculopathy/Myelopathy
- Recent injection or physical therapy within the last 3 months
- Neck and shoulder surgery
- Neurological and inflammatory diseases
- Pregnancy
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 |
|---|---|---|
| AssessmentThe patients' demographic information, weight and height measurements, occupational activities and desk work time, daily screen usage time, pain intensity (with VAS), cervical joint range of motion examination, pain threshold (with pressure algometer), functional status (with Neck Pain Disability Scale), sleep quality (with Pittsburgh Sleep Quality Scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspects of pain (with Pain Catastrophizing Scale) will be evaluated. The patients' chronotype preferences will be evaluated with Morningness Eveningness Questionnaire. | Other | MPS |
Primary outcome
VAS
Time frame: "Baseline"
The Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at 0, and that the most severe pain they have ever felt at 100, and the patient is asked to put a mark on the point corresponding to their pain.
Pressure Algometry Measurements: (kg/cm2)
Time frame: "Baseline"
Algometry measurements will be measured with the Baseline Push Pull Force Gauge ® (Fabrication Enterprises, Inc. PO Box 1500, White Plains, New York 10602, USA) algometry device from the painful trigger point area with the patient in a sitting position. Pressure will be applied slowly until the participant first feels pain and responds by saying "stop" and three measurements will be taken with a 30-second interval after each measurement and the average of the three measurements will be recorded as the final value.
Cervical joint range of motion
Time frame: "Baseline"
Active passive ROM (flexion, extension, right-left) flexion and rotation) of the cervical joint will be measured.
Morningness Eveningness Questionnaire
Time frame: "Baseline"
One of the most widely used tools to assess sleep chronotype preferences. This 19-item screening questionnaire has a rating range of 16 to 86. The scoring results are classified as follows: evening types with scores between 16 and 41, morning types with scores between 59 and 86, and no types with scores between 42 and 58. The Turkish version has been shown to have good validity and reliability
5 secondary outcomes
Neck Pain Disability Scale
Time frame: "Baseline"
Pittsburg Sleep Quality Index (PSQI)
Time frame: "Baseline"
Beck Depression Anxiety Inventory
Time frame: "Baseline"
The Pain Catastrophizing Scale
Time frame: "Baseline"
SF-12
Time frame: "Baseline"
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 2 Dec 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain Syndrome, Diffuse, run by Afyonkarahisar Health Sciences University.
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 2 inclusion and 6 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 SEVDA ADAR, Ass. Prof. (+905325940725, drsevdaadar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: "Baseline"). 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 2 Dec 2024.