Fibromyalgia SyndromeNCT06851091
Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia
An observational study of Fibromyalgia Syndrome and Central Sensitisation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia. The main questions it aims to answer are: Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals?… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome, Central Sensitisation, Postural Balance
- What is being tested?
- Biodex Balance System, Pressure Pain Threshold (PPT) Measurement with Algometer and Conditioned Pain Modulation (CPM)
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2025to Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria
Who may be able to join
- Diagnosis of FMS according to the ACR 2016 diagnostic criteria
- Being between the ages of 18 and 65
- Being literate
- Providing informed consent by signing the voluntary consent form
Who cannot join
- Being under 18 years old or over 65 years old
- Presence of vestibular disorders
- Having undergone spinal and/or extremity surgery (such as for back/hip/knee/foot) within the last 6 months
- History of lower extremity amputation
- Presence of spinal deformities
- Peripheral arterial disease
Show all 12Show fewer
- Vitamin B12 deficiency
- Any neurological disorder (e.g., stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies, etc.)
- Severe cardiopulmonary insufficiency (stage 3-4)
- Uncontrolled systemic diseases such as hypertension and diabetes
- Presence of systemic inflammatory diseases, malignancies, or active infections
- Pregnancy
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, 1 recruiting
- Recruiting
Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar
Istanbul, Üsküdar
Melike Ünsal Küçük, Principal Investigator, +90 537 739 62 00, melikeunsal463@gmail.com
About this study
Official title: Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia
The aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia.
The main questions it aims to answer are:
- Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals?
- How is balance performance in these individuals compared to healthy controls?
- Do central sensitization parameters affect static and dynamic balance in patients with fibromyalgia?
- Do central sensitization parameters lead to quantitative changes in balance in patients with fibromyalgia?
Read the detailed description
Fibromyalgia is a syndrome characterized by chronic and widespread musculoskeletal pain. It is often accompanied by other symptoms such as fatigue, bowel disorders, sleep disturbances, and mood changes. It is estimated that fibromyalgia syndrome (FMS) affects approximately 2% to 8% of the global population.
The American College of Rheumatology (ACR) diagnostic criteria, based on the presence of multiple tender points, widespread chronic pain, somatic symptoms (such as headaches and abdominal pain), and cognitive symptoms, are used to diagnose individuals with fibromyalgia syndrome (FMS). Widespread pain, headaches, muscle spasms, and balance disorders are the most common symptoms leading to physical disability. These disabling symptoms reduce quality of life and make daily activities more difficult. The impact of these symptoms results in an annual cost of €7,256-7,900 per diagnosed patient in developed countries, creating a secondary socioeconomic burden . This burden includes high absenteeism, unemployment, early retirement, and an increased number of sick leave days.
Postural stability is a complex task required to maintain balance and orientation in a gravity-based environment. This task necessitates the rapid and dynamic integration of sensory information from the somatosensory, vestibular, and visual systems, which are essential for maintaining balance. Changes in balance are associated with poor balance confidence, which increases the risk of falls. Balance disorders are among the most common symptoms in patients with fibromyalgia syndrome (FMS), with a prevalence ranging from 45% to 68%. Previous studies have demonstrated that balance disorders are more prevalent in FMS patients compared to healthy individuals. Furthermore, in FMS patients with impaired balance, a correlation has been shown between balance disorders and an increased risk and/or frequency of falls. However, the underlying mechanism of balance problems in these patients has not yet been elucidated.
FMS is known to originate from a central sensitization phenomenon. According to the International Association for the Study of Pain, central sensitization is defined as an increased response of central nervous system (CNS) neurons to normal or subthreshold afferent inputs. It is hypothesized that changes in postural control may be a response to impaired sensory processing within the CNS and that the increased responsiveness of nociceptive neurons and the presence of central sensitization in the CNS may affect postural control processing, altering neuromuscular interactions and disrupting balance.
Central sensitization, one of the key mechanisms in the pathogenesis of FMS, has been reported to play a significant role in balance control in a study conducted by Sennholz et al. on patients with migraines. In this study, which included migraine patients and healthy controls, balance assessment was performed alongside an evaluation of central sensitization using quantitative sensory tests (cold and heat pain thresholds, mechanical pain thresholds, and pressure pain thresholds) and the central sensitization inventory. The results demonstrated that balance impairment in migraine patients was associated with a decreased pain threshold and an increased central sensitization inventory score.
To our knowledge, no study has yet quantitatively investigated the relationship between central sensitization levels and balance performance in FMS. Based on these findings, we aim to determine the relationship between central sensitization parameters and static and dynamic balance changes in FMS, a member of the central sensitivity syndrome family, similar to migraines. Furthermore, we seek to highlight the importance of future rehabilitation interventions targeting this relationship, thereby contributing to the existing literature.
The study will be conducted as an observational, single-center study at the Physical Medicine and Rehabilitation Clinic of Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital, involving patients diagnosed with FMS and healthy volunteers.
As part of the study, demographic data including participants' age, gender, height, weight, body mass index, smoking and alcohol use, marital status, occupation, education level, current medications, presence of comorbidities, and duration of FMS diagnosis will be recorded. Patients will be evaluated once, and the assessment will consist of the following:
- Biodex Balance System [Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)]
- Quantitative Sensory Testing, including Pressure Pain Threshold Measurement with an Algometer and Conditioned Pain Modulation
- Slowly Repeated Evoked Pain Assessment Protocol
- Central Sensitization Inventory
- Numeric Rating Scale
- Revised Fibromyalgia Impact Questionnaire
- S-LANSS Pain Score
- Tampa Kinesiophobia Scale
- Hospital Anxiety and Depression Scale
- SF-12 Quality of Life Scale
- Fatigue Severity Scale
- Timed Up and Go Test
Number of Patients to be Included in the Study:The number of patients to be included in the study has been planned based on the study by Sennholz et al., published in May 2024, using G-power version 3.1. The study will include 20 healthy controls and 55 fibromyalgia patients.
Statistical Methods:The distribution pattern of the data and the tests to be applied will be determined based on the Kolmogorov-Smirnov test, skewness, and kurtosis values. If the data follow a parametric distribution, they will be presented as mean ± standard deviation and 95% confidence interval; if the data follow a non-parametric distribution, they will be presented as median ± interquartile range (IQR).
Pressure pain threshold measurements with the algometer, conditioned pain modulation measurements, slowly repeated evoked pain measurements, and balance parameters will be compared between the patient and control groups using independent group T-tests or Mann-Whitney U tests. The linear relationships between algometer pressure pain threshold measurements, conditioned pain modulation, slowly repeated evoked pain measurements, and clinical parameters will be examined using Spearman/Pearson correlation analysis. For parametric data, multiple regression models may be constructed based on the characteristics of the variables.
- Being tested
- Biodex Balance System, Pressure Pain Threshold (PPT) Measurement with Algometer, Conditioned Pain Modulation (CPM), Slowly Repeated Evoked Pain Assessment Protocol (SREP), Central Sensitization Inventory (CSI)
- Keywords
- Fibromyalgia, Central Sensitisation, Balance Changes, Postural Balance
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance SystemDiagnostic test
Biodex Balance System [Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)]:The Biodex Balance System is a computer-assisted device that assesses postural stability. It measures static and dynamic balance, fall risk, and proprioception through different difficulty levels and test protocols. In our study, this system will be used to investigate the relationship between balance and central sensitization. Participants will be evaluated using the postural stability test, fall risk test, athlete single leg test, and limits of stability test protocols, and they will be trained before the testing process.
Pressure Pain Threshold (PPT) Measurement with AlgometerDiagnostic test
Pressure pain threshold (PPT) is defined as the minimum force applied that causes pain. This measurement is commonly used for assessing tender points and has been shown to be useful.
Conditioned Pain Modulation (CPM)Diagnostic test
According to this protocol, a pressure stimulus, referred to as the test stimulus, will first be applied to the trapezius muscle to induce a pain intensity of 4 on a 10-point Numeric Rating Scale (NRS). Subsequently, a conditioning stimulus will be introduced by immersing the participant's right hand in 7°C water for 20 seconds. Following this conditioning stimulus, the same test stimulus will be reapplied to the trapezius muscle, and participants will be asked to rate their pain using the NRS. If participants are unable to keep their hands in the water for the full 20 seconds, the test stimulus will be applied immediately after hand removal. The CPM score will be calculated as the ratio of the initial NRS score to the second NRS score, multiplied by 100. Scores above 100 are considered indicative of a normal CPM response, with higher scores reflecting greater descending pain inhibition.
Slowly Repeated Evoked Pain Assessment Protocol (SREP)Diagnostic test
Responses to induced pain indicate the presence of allodynia and hyperalgesia in FMS patients. The Slow Repetitive Evoked Pain (SREP) protocol consists of nine suprathreshold painful stimuli applied to the nail bed for five seconds each, with 30-second intervals. Painful stimulation will be administered using a pressure algometer with a 1 cm² stimulation surface. Nailbed pain stimuli are commonly used to assess pain sensitivity.
The intensity of pain perception from each SREP stimulus will be evaluated using a 10-point Numerical Rating Scale (NRS) (0 = no pain, 10 = extremely painful). The SREP sensitization index will be calculated as the difference between the final and initial pain scores.
Higher positive SREP sensitization index values indicate a greater increase in perceived pain intensity across the nine stimuli, reflecting higher pain sensitization.
Central Sensitization Inventory (CSI)Diagnostic test
The Central Sensitization Inventory (CSI) is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization.
The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization.
This scale has been shown to be a reliable and valid tool in the Turkish population with chronic pain (test-retest reliability = 0.92, Cronbach's alpha = 0.93)
Numeric Rating Scale (NRS)Diagnostic test
Numeric Rating Scale (NRS) will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.
Revised Fibromyalgia Impact Questionnaire (FIQ)Diagnostic test
Revised Fibromyalgia Impact Questionnaire (FIQ) consists of three sections: function, general, and symptoms, with a total of 21 questions. It evaluates the limitations and functional disability that occur in patients with fibromyalgia. All questions are scored on the Numeric Rating Scale (NRS), ranging from 0 to 10. As the score from the questionnaire increases, it indicates a higher level of disability related to fibromyalgia. In our study, the Turkish version of the questionnaire, which has been validated and shown to be reliable, will be used.
S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)Diagnostic test
The S-LANSS pain score is a 7-item self-administered scale developed and validated to recognize neuropathic pain in chronic pain patients and distinguish it from nociceptive pain. It evaluates neuropathic symptoms and signs through a series of questions that help identify features like hyperalgesia, allodynia, and paresthesia, which characterize the chronic pain sensation associated with neuropathic pain. These features are often seen in fibromyalgia (FMS) pain. In our study, the Turkish version of the questionnaire, which has undergone validity and reliability testing, will be used.
Tampa Kinesiophobia Scale (TKS)Diagnostic test
The Tampa Kinesiophobia Scale is a 17-item measure designed to assess fear of movement/re-injury. The scale evaluates fear-avoidance behaviors related to work activities, injury/re-injury concerns, and fear-avoidance parameters. It is used in the context of acute and chronic low back pain, fibromyalgia (FMS), musculoskeletal injuries, and whiplash-associated disorders.
The scale uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). After reversing the scores for items 4, 8, 12, and 16 (for example, if a participant selects 1 for these items, it is counted as 4; 2 is counted as 3, etc.), the total score is calculated. The participant receives a score between 17 and 68. A higher score on the scale indicates a higher level of kinesiophobia. In our study, the Turkish version of the scale, which has undergone validity and reliability testing, will be used.
Hospital Anxiety and Depression Scale (HAD)Diagnostic test
This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21:
- 0-7 points: No symptoms or very mild symptoms
- 8-10 points: Moderate symptoms
- 11 points or higher: Symptoms likely corresponding to a clinical diagnosis of anxiety and depression According to the 2016 diagnostic criteria for Fibromyalgia Syndrome (FMS), the presence of depression contributes to the diagnosis of FMS. The HAD scale has been shown to be a suitable tool for assessing FMS and related patient education programs.
In our study, the Turkish version of the HAD scale, which has been validated and shown to be reliable, will be used.
SF-12 Health Survey (SF-12 Quality of Life Scale)Diagnostic test
The SF-12 Health Survey is one of the most widely used scales for assessing health-related quality of life. In our study, the Turkish version of the SF-12, which has been validated and shown to be reliable, will be used. The scores will be calculated using an online calculation tool, and two types of scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-will be obtained.
Fatigue Severity Scale (FSS)Diagnostic test
The Fatigue Severity Scale (FSS) is a 9-item questionnaire used to assess the severity, frequency, and impact of fatigue on daily life. Each item is rated on a scale from 1 to 7. A lower score indicates a decrease in fatigue severity. In our study, the Turkish version of the scale, which has been validated and shown to be reliable, will be used.
Timed Up and Go Test (TUG)Diagnostic test
The Timed Up and Go (TUG) test is designed to measure dynamic balance based on the time it takes for participants to stand up and walk. The patient begins by sitting on a standardized chair (height of 46 cm). During the test, the patient is asked to stand up from the chair, walk 3 meters, turn around, and return to sit back on the chair. The time taken to complete this process is measured. Lower values indicate better stability. A cut-off value of 13.5 seconds is used to identify individuals at higher risk of falling.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Healthy volunteers) | Healthy volunteers without a diagnosis of Fibromyalgia Syndrome will be included in Group 1. (n=20) Receives: Diagnostic Test: Biodex Balance System; Diagnostic Test: Pressure Pain Threshold (PPT) Measurement with Algometer; Diagnostic Test: Conditioned Pain Modulation (CPM); Diagnostic Test: Slowly Repeated Evoked Pain Assessment Protocol (SREP); Diagnostic Test: Central Sensitization Inventory (CSI); Diagnostic Test: Numeric Rating Scale (NRS); Diagnostic Test: Revised Fibromyalgia Impact Questionnaire (FIQ); Diagnostic Test: S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs); Diagnostic Test: Tampa Kinesiophobia Scale (TKS); Diagnostic Test: Hospital Anxiety and Depression Scale (HAD); Diagnostic Test: SF-12 Health Survey (SF-12 Quality of Life Scale); Diagnostic Test: Fatigue Severity Scale (FSS); Diagnostic Test: Timed Up and Go Test (TUG) | |
| Group 2 (Patients with fibromyalgia syndrome) | Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria will be included in Group 2. (n=55) Receives: Diagnostic Test: Biodex Balance System; Diagnostic Test: Pressure Pain Threshold (PPT) Measurement with Algometer; Diagnostic Test: Conditioned Pain Modulation (CPM); Diagnostic Test: Slowly Repeated Evoked Pain Assessment Protocol (SREP); Diagnostic Test: Central Sensitization Inventory (CSI); Diagnostic Test: Numeric Rating Scale (NRS); Diagnostic Test: Revised Fibromyalgia Impact Questionnaire (FIQ); Diagnostic Test: S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs); Diagnostic Test: Tampa Kinesiophobia Scale (TKS); Diagnostic Test: Hospital Anxiety and Depression Scale (HAD); Diagnostic Test: SF-12 Health Survey (SF-12 Quality of Life Scale); Diagnostic Test: Fatigue Severity Scale (FSS); Diagnostic Test: Timed Up and Go Test (TUG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT) Measurement with Algometer
Pressure pain threshold (PPT) is defined as the minimum force applied that causes pain. This measurement is commonly used for assessing tender points and has been shown to be useful.
Measured: 5 months
Conditioned Pain Modulation (CPM)
According to this protocol, a pressure stimulus, referred to as the test stimulus, will first be applied to the trapezius muscle to induce a pain intensity of 4 on a 10-point Numeric Rating Scale (NRS). Subsequently, a conditioning stimulus will be introduced by immersing the participant's right hand in 7°C water for 20 seconds. Following this conditioning stimulus, the same test stimulus will be reapplied to the trapezius muscle, and participants will be asked to rate their pain using the NRS. If participants are unable to keep their hands in the water for the full 20 seconds, the test stimulus will be applied immediately after hand removal. The CPM score will be calculated as the ratio of the initial NRS score to the second NRS score, multiplied by 100. Scores above 100 are considered indicative of a normal CPM response, with higher scores reflecting greater descending pain inhibition.
Measured: 5 months
Slowly Repeated Evoked Pain Assessment Protocol (SREP)
Responses to induced pain indicate the presence of allodynia and hyperalgesia in FMS patients. The Slowly Repeated Evoked Pain Assessment Protocol (SREP) consists of nine suprathreshold painful stimuli applied to the nail bed for five seconds each, with 30-second intervals. Painful stimulation will be administered using a pressure algometer with a 1 cm² stimulation surface. Nailbed pain stimuli are commonly used to assess pain sensitivity. The intensity of pain perception from each SREP stimulus will be evaluated using a 10-point Numerical Rating Scale (NRS) (0 = no pain, 10 = extremely painful). The SREP sensitization index will be calculated as the difference between the final and initial pain scores. Higher positive SREP sensitization index values indicate a greater increase in perceived pain intensity across the nine stimuli, reflecting higher pain sensitization.
Measured: 5 months
Secondary outcomes (10)
Biodex Balance System
[Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)]:The Biodex Balance System is a computer-assisted device that assesses postural stability. It measures static and dynamic balance, fall risk, and proprioception through different difficulty levels and test protocols. In our study, this system will be used to investigate the relationship between balance and central sensitization. Participants will be evaluated using the postural stability test, fall risk test, athlete single leg test, and limits of stability test protocols, and they will be trained before the testing process.
Measured: 5 months
The Central Sensitization Inventory (CSI)
The Central Sensitization Inventory (CSI) is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization. This scale has been shown to be a reliable and valid tool in the Turkish population with chronic pain (test-retest reliability = 0.92, Cronbach's alpha = 0.93)
Measured: 5 months
Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.
Measured: 5 months
Revised Fibromyalgia Impact Questionnaire (FIQ)
Revised Fibromyalgia Impact Questionnaire (FIQ) consists of three sections: function, general, and symptoms, with a total of 21 questions. It evaluates the limitations and functional disability that occur in patients with fibromyalgia. All questions are scored on the Numeric Rating Scale (NRS), ranging from 0 to 10. As the score from the questionnaire increases, it indicates a higher level of disability related to fibromyalgia. In our study, the Turkish version of the questionnaire, which has been validated and shown to be reliable, will be used.
Measured: 5 months
S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)
The S-LANSS pain score is a 7-item self-administered scale developed and validated to recognize neuropathic pain in chronic pain patients and distinguish it from nociceptive pain. It evaluates neuropathic symptoms and signs through a series of questions that help identify features like hyperalgesia, allodynia, and paresthesia, which characterize the chronic pain sensation associated with neuropathic pain. These features are often seen in fibromyalgia (FMS) pain. In our study, the Turkish version of the questionnaire, which has undergone validity and reliability testing, will be used.
Measured: 5 months
Tampa Kinesiophobia Scale (TKS)
The Tampa Kinesiophobia Scale is a 17-item measure designed to assess fear of movement/re-injury. The scale evaluates fear-avoidance behaviors related to work activities, injury/re-injury concerns, and fear-avoidance parameters. It is used in the context of acute and chronic low back pain, fibromyalgia (FMS), musculoskeletal injuries, and whiplash-associated disorders. The scale uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). After reversing the scores for items 4, 8, 12, and 16 (for example, if a participant selects 1 for these items, it is counted as 4; 2 is counted as 3, etc.), the total score is calculated. The participant receives a score between 17 and 68. A higher score on the scale indicates a higher level of kinesiophobia. In our study, the Turkish version of the scale, which has undergone validity and reliability testing, will be used.
Measured: 5 months
Hospital Anxiety and Depression Scale (HAD)
This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21:
- 0-7 points: No symptoms or very mild symptoms
- 8-10 points: Moderate symptoms
- 11 points or higher: Symptoms likely corresponding to a clinical diagnosis of anxiety and depression According to the 2016 diagnostic criteria for Fibromyalgia Syndrome (FMS), the presence of depression contributes to the diagnosis of FMS. The HAD scale has been shown to be a suitable tool for assessing FMS and related patient education programs.
In our study, the Turkish version of the HAD scale, which has been validated and shown to be reliable, will be used.
Measured: 5 months
SF-12 Health Survey (SF-12 Quality of Life Scale)
The SF-12 Health Survey is one of the most widely used scales for assessing health-related quality of life. In our study, the Turkish version of the SF-12, which has been validated and shown to be reliable, will be used. The scores will be calculated using an online calculation tool, and two types of scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-will be obtained.
Measured: 5 months
The Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item questionnaire used to assess the severity, frequency, and impact of fatigue on daily life. Each item is rated on a scale from 1 to 7. A lower score indicates a decrease in fatigue severity. In our study, the Turkish version of the scale, which has been validated and shown to be reliable, will be used.
Measured: 5 months
The Timed Up and Go (TUG)
The Timed Up and Go (TUG) test is designed to measure dynamic balance based on the time it takes for participants to stand up and walk. The patient begins by sitting on a standardized chair (height of 46 cm). During the test, the patient is asked to stand up from the chair, walk 3 meters, turn around, and return to sit back on the chair. The time taken to complete this process is measured. Lower values indicate better stability. A cut-off value of 13.5 seconds is used to identify individuals at higher risk of falling.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start18 Feb 2025
- Primary completion4 Sep 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Emre Ata, Asst. Prof., Study director, Health Sciences University Sultan 2.Abdülhamid Han Training and Research HospitalFeyza Nur Yücel, Specialist, Study director, Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851091
- Sponsor's protocol ID
- 24/759
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dataset sharing is not planned
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06851091
- Acronym / sponsor ID
- 24/759
- Keywords
- Fibromyalgia, Central Sensitisation, Balance Changes, Postural Balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 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 aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia.
The main questions it aims to answer are:
- Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals?
- How is balance performance in these individuals compared to healthy controls?
- Do central sensitization parameters affect static and dynamic balance in patients with fibromyalgia?
- Do central sensitization parameters lead to quantitative changes in balance in patients with fibromyalgia?
Detailed description
Fibromyalgia is a syndrome characterized by chronic and widespread musculoskeletal pain. It is often accompanied by other symptoms such as fatigue, bowel disorders, sleep disturbances, and mood changes. It is estimated that fibromyalgia syndrome (FMS) affects approximately 2% to 8% of the global population.
The American College of Rheumatology (ACR) diagnostic criteria, based on the presence of multiple tender points, widespread chronic pain, somatic symptoms (such as headaches and abdominal pain), and cognitive symptoms, are used to diagnose individuals with fibromyalgia syndrome (FMS). Widespread pain, headaches, muscle spasms, and balance disorders are the most common symptoms leading to physical disability. These disabling symptoms reduce quality of life and make daily activities more difficult. The impact of these symptoms results in an annual cost of €7,256-7,900 per diagnosed patient in developed countries, creating a secondary socioeconomic burden . This burden includes high absenteeism, unemployment, early retirement, and an increased number of sick leave days.
Postural stability is a complex task required to maintain balance and orientation in a gravity-based environment. This task necessitates the rapid and dynamic integration of sensory information from the somatosensory, vestibular, and visual systems, which are essential for maintaining balance. Changes in balance are associated with poor balance confidence, which increases the risk of falls. Balance disorders are among the most common symptoms in patients with fibromyalgia syndrome (FMS), with a prevalence ranging from 45% to 68%. Previous studies have demonstrated that balance disorders are more prevalent in FMS patients compared to healthy individuals. Furthermore, in FMS patients with impaired balance, a correlation has been shown between balance disorders and an increased risk and/or frequency of falls. However, the underlying mechanism of balance problems in these patients has not yet been elucidated.
FMS is known to originate from a central sensitization phenomenon. According to the International Association for the Study of Pain, central sensitization is defined as an increased response of central nervous system (CNS) neurons to normal or subthreshold afferent inputs. It is hypothesized that changes in postural control may be a response to impaired sensory processing within the CNS and that the increased responsiveness of nociceptive neurons and the presence of central sensitization in the CNS may affect postural control processing, altering neuromuscular interactions and disrupting balance.
Central sensitization, one of the key mechanisms in the pathogenesis of FMS, has been reported to play a significant role in balance control in a study conducted by Sennholz et al. on patients with migraines. In this study, which included migraine patients and healthy controls, balance assessment was performed alongside an evaluation of central sensitization using quantitative sensory tests (cold and heat pain thresholds, mechanical pain thresholds, and pressure pain thresholds) and the central sensitization inventory. The results demonstrated that balance impairment in migraine patients was associated with a decreased pain threshold and an increased central sensitization inventory score.
To our knowledge, no study has yet quantitatively investigated the relationship between central sensitization levels and balance performance in FMS. Based on these findings, we aim to determine the relationship between central sensitization parameters and static and dynamic balance changes in FMS, a member of the central sensitivity syndrome family, similar to migraines. Furthermore, we seek to highlight the importance of future rehabilitation interventions targeting this relationship, thereby contributing to the existing literature.
The study will be conducted as an observational, single-center study at the Physical Medicine and Rehabilitation Clinic of Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital, involving patients diagnosed with FMS and healthy volunteers.
As part of the study, demographic data including participants' age, gender, height, weight, body mass index, smoking and alcohol use, marital status, occupation, education level, current medications, presence of comorbidities, and duration of FMS diagnosis will be recorded. Patients will be evaluated once, and the assessment will consist of the following:
- Biodex Balance System [Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)]
- Quantitative Sensory Testing, including Pressure Pain Threshold Measurement with an Algometer and Conditioned Pain Modulation
- Slowly Repeated Evoked Pain Assessment Protocol
- Central Sensitization Inventory
- Numeric Rating Scale
- Revised Fibromyalgia Impact Questionnaire
- S-LANSS Pain Score
- Tampa Kinesiophobia Scale
- Hospital Anxiety and Depression Scale
- SF-12 Quality of Life Scale
- Fatigue Severity Scale
- Timed Up and Go Test
Number of Patients to be Included in the Study:The number of patients to be included in the study has been planned based on the study by Sennholz et al., published in May 2024, using G-power version 3.1. The study will include 20 healthy controls and 55 fibromyalgia patients.
Statistical Methods:The distribution pattern of the data and the tests to be applied will be determined based on the Kolmogorov-Smirnov test, skewness, and kurtosis values. If the data follow a parametric distribution, they will be presented as mean ± standard deviation and 95% confidence interval; if the data follow a non-parametric distribution, they will be presented as median ± interquartile range (IQR).
Pressure pain threshold measurements with the algometer, conditioned pain modulation measurements, slowly repeated evoked pain measurements, and balance parameters will be compared between the patient and control groups using independent group T-tests or Mann-Whitney U tests. The linear relationships between algometer pressure pain threshold measurements, conditioned pain modulation, slowly repeated evoked pain measurements, and clinical parameters will be examined using Spearman/Pearson correlation analysis. For parametric data, multiple regression models may be constructed based on the characteristics of the variables.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Healthy volunteers) | – | Diagnostic Test: Biodex Balance System, Diagnostic Test: Pressure Pain Threshold (PPT) Measurement with Algometer, Diagnostic Test: Conditioned Pain Modulation (CPM), Diagnostic Test: Slowly Repeated Evoked Pain Assessment Protocol (SREP), Diagnostic Test: Central Sensitization Inventory (CSI), Diagnostic Test: Numeric Rating Scale (NRS), Diagnostic Test: Revised Fibromyalgia Impact Questionnaire (FIQ), Diagnostic Test: S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs), Diagnostic Test: Tampa Kinesiophobia Scale (TKS), Diagnostic Test: Hospital Anxiety and Depression Scale (HAD), Diagnostic Test: SF-12 Health Survey (SF-12 Quality of Life Scale), Diagnostic Test: Fatigue Severity Scale (FSS), Diagnostic Test: Timed Up and Go Test (TUG)Healthy volunteers without a diagnosis of Fibromyalgia Syndrome will be included in Group 1. (n=20) |
| Group 2 (Patients with fibromyalgia syndrome) | – | Diagnostic Test: Biodex Balance System, Diagnostic Test: Pressure Pain Threshold (PPT) Measurement with Algometer, Diagnostic Test: Conditioned Pain Modulation (CPM), Diagnostic Test: Slowly Repeated Evoked Pain Assessment Protocol (SREP), Diagnostic Test: Central Sensitization Inventory (CSI), Diagnostic Test: Numeric Rating Scale (NRS), Diagnostic Test: Revised Fibromyalgia Impact Questionnaire (FIQ), Diagnostic Test: S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs), Diagnostic Test: Tampa Kinesiophobia Scale (TKS), Diagnostic Test: Hospital Anxiety and Depression Scale (HAD), Diagnostic Test: SF-12 Health Survey (SF-12 Quality of Life Scale), Diagnostic Test: Fatigue Severity Scale (FSS), Diagnostic Test: Timed Up and Go Test (TUG)Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria will be included in Group 2. (n=55) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria
Key inclusion criteria (4 listed)
- Diagnosis of FMS according to the ACR 2016 diagnostic criteria
- Being between the ages of 18 and 65
- Being literate
- Providing informed consent by signing the voluntary consent form
Key exclusion criteria (12 listed)
- Being under 18 years old or over 65 years old
- Presence of vestibular disorders
- Having undergone spinal and/or extremity surgery (such as for back/hip/knee/foot) within the last 6 months
- History of lower extremity amputation
- Presence of spinal deformities
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 |
|---|---|---|
| Biodex Balance SystemBiodex Balance System [Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS)]:The Biodex Balance System is a computer-assisted device that assesses postural stability. It measures static and dynamic balance, fall risk, and proprioception through different difficulty levels and test protocols. In our study, this system will be used to investigate the relationship between balance and central sensitization. Participants will be evaluated using the postural stability test, fall risk test, athlete single leg test, and limits of stability test protocols, and they will be trained before the testing process. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Pressure Pain Threshold (PPT) Measurement with AlgometerPressure pain threshold (PPT) is defined as the minimum force applied that causes pain. This measurement is commonly used for assessing tender points and has been shown to be useful. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Conditioned Pain Modulation (CPM)According to this protocol, a pressure stimulus, referred to as the test stimulus, will first be applied to the trapezius muscle to induce a pain intensity of 4 on a 10-point Numeric Rating Scale (NRS). Subsequently, a conditioning stimulus will be introduced by immersing the participant's right hand in 7°C water for 20 seconds. Following this conditioning stimulus, the same test stimulus will be reapplied to the trapezius muscle, and participants will be asked to rate their pain using the NRS. If participants are unable to keep their hands in the water for the full 20 seconds, the test stimulus will be applied immediately after hand removal. The CPM score will be calculated as the ratio of the initial NRS score to the second NRS score, multiplied by 100. Scores above 100 are considered indicative of a normal CPM response, with higher scores reflecting greater descending pain inhibition. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Slowly Repeated Evoked Pain Assessment Protocol (SREP)Responses to induced pain indicate the presence of allodynia and hyperalgesia in FMS patients. The Slow Repetitive Evoked Pain (SREP) protocol consists of nine suprathreshold painful stimuli applied to the nail bed for five seconds each, with 30-second intervals. Painful stimulation will be administered using a pressure algometer with a 1 cm² stimulation surface. Nailbed pain stimuli are commonly used to assess pain sensitivity. The intensity of pain perception from each SREP stimulus will be evaluated using a 10-point Numerical Rating Scale (NRS) (0 = no pain, 10 = extremely painful). The SREP sensitization index will be calculated as the difference between the final and initial pain scores. Higher positive SREP sensitization index values indicate a greater increase in perceived pain intensity across the nine stimuli, reflecting higher pain sensitization. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Central Sensitization Inventory (CSI)The Central Sensitization Inventory (CSI) is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization. This scale has been shown to be a reliable and valid tool in the Turkish population with chronic pain (test-retest reliability = 0.92, Cronbach's alpha = 0.93) | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Numeric Rating Scale (NRS)Numeric Rating Scale (NRS) will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Revised Fibromyalgia Impact Questionnaire (FIQ)Revised Fibromyalgia Impact Questionnaire (FIQ) consists of three sections: function, general, and symptoms, with a total of 21 questions. It evaluates the limitations and functional disability that occur in patients with fibromyalgia. All questions are scored on the Numeric Rating Scale (NRS), ranging from 0 to 10. As the score from the questionnaire increases, it indicates a higher level of disability related to fibromyalgia. In our study, the Turkish version of the questionnaire, which has been validated and shown to be reliable, will be used. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)The S-LANSS pain score is a 7-item self-administered scale developed and validated to recognize neuropathic pain in chronic pain patients and distinguish it from nociceptive pain. It evaluates neuropathic symptoms and signs through a series of questions that help identify features like hyperalgesia, allodynia, and paresthesia, which characterize the chronic pain sensation associated with neuropathic pain. These features are often seen in fibromyalgia (FMS) pain. In our study, the Turkish version of the questionnaire, which has undergone validity and reliability testing, will be used. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Tampa Kinesiophobia Scale (TKS)The Tampa Kinesiophobia Scale is a 17-item measure designed to assess fear of movement/re-injury. The scale evaluates fear-avoidance behaviors related to work activities, injury/re-injury concerns, and fear-avoidance parameters. It is used in the context of acute and chronic low back pain, fibromyalgia (FMS), musculoskeletal injuries, and whiplash-associated disorders. The scale uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). After reversing the scores for items 4, 8, 12, and 16 (for example, if a participant selects 1 for these items, it is counted as 4; 2 is counted as 3, etc.), the total score is calculated. The participant receives a score between 17 and 68. A higher score on the scale indicates a higher level of kinesiophobia. In our study, the Turkish version of the scale, which has undergone validity and reliability testing, will be used. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Hospital Anxiety and Depression Scale (HAD)This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21: * 0-7 points: No symptoms or very mild symptoms * 8-10 points: Moderate symptoms * 11 points or higher: Symptoms likely corresponding to a clinical diagnosis of anxiety and depression According to the 2016 diagnostic criteria for Fibromyalgia Syndrome (FMS), the presence of depression contributes to the diagnosis of FMS. The HAD scale has been shown to be a suitable tool for assessing FMS and related patient education programs. In our study, the Turkish version of the HAD scale, which has been validated and shown to be reliable, will be used. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| SF-12 Health Survey (SF-12 Quality of Life Scale)The SF-12 Health Survey is one of the most widely used scales for assessing health-related quality of life. In our study, the Turkish version of the SF-12, which has been validated and shown to be reliable, will be used. The scores will be calculated using an online calculation tool, and two types of scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-will be obtained. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Fatigue Severity Scale (FSS)The Fatigue Severity Scale (FSS) is a 9-item questionnaire used to assess the severity, frequency, and impact of fatigue on daily life. Each item is rated on a scale from 1 to 7. A lower score indicates a decrease in fatigue severity. In our study, the Turkish version of the scale, which has been validated and shown to be reliable, will be used. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
| Timed Up and Go Test (TUG)The Timed Up and Go (TUG) test is designed to measure dynamic balance based on the time it takes for participants to stand up and walk. The patient begins by sitting on a standardized chair (height of 46 cm). During the test, the patient is asked to stand up from the chair, walk 3 meters, turn around, and return to sit back on the chair. The time taken to complete this process is measured. Lower values indicate better stability. A cut-off value of 13.5 seconds is used to identify individuals at higher risk of falling. | Diagnostic test | Group 1 (Healthy volunteers), Group 2 (Patients with fibromyalgia syndrome) |
Primary outcome
Pressure Pain Threshold (PPT) Measurement with Algometer
Time frame: 5 months
Pressure pain threshold (PPT) is defined as the minimum force applied that causes pain. This measurement is commonly used for assessing tender points and has been shown to be useful.
Conditioned Pain Modulation (CPM)
Time frame: 5 months
According to this protocol, a pressure stimulus, referred to as the test stimulus, will first be applied to the trapezius muscle to induce a pain intensity of 4 on a 10-point Numeric Rating Scale (NRS). Subsequently, a conditioning stimulus will be introduced by immersing the participant's right hand in 7°C water for 20 seconds. Following this conditioning stimulus, the same test stimulus will be reapplied to the trapezius muscle, and participants will be asked to rate their pain using the NRS. If participants are unable to keep their hands in the water for the full 20 seconds, the test stimulus will be applied immediately after hand removal. The CPM score will be calculated as the ratio of the initial NRS score to the second NRS score, multiplied by 100. Scores above 100 are considered indicative of a normal CPM response, with higher scores reflecting greater descending pain inhibition.
Slowly Repeated Evoked Pain Assessment Protocol (SREP)
Time frame: 5 months
Responses to induced pain indicate the presence of allodynia and hyperalgesia in FMS patients. The Slowly Repeated Evoked Pain Assessment Protocol (SREP) consists of nine suprathreshold painful stimuli applied to the nail bed for five seconds each, with 30-second intervals. Painful stimulation will be administered using a pressure algometer with a 1 cm² stimulation surface. Nailbed pain stimuli are commonly used to assess pain sensitivity. The intensity of pain perception from each SREP stimulus will be evaluated using a 10-point Numerical Rating Scale (NRS) (0 = no pain, 10 = extremely painful). The SREP sensitization index will be calculated as the difference between the final and initial pain scores. Higher positive SREP sensitization index values indicate a greater increase in perceived pain intensity across the nine stimuli, reflecting higher pain sensitization.
10 secondary outcomes
Biodex Balance System
Time frame: 5 months
The Central Sensitization Inventory (CSI)
Time frame: 5 months
Numeric Rating Scale (NRS)
Time frame: 5 months
Revised Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 5 months
S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)
Time frame: 5 months
Tampa Kinesiophobia Scale (TKS)
Time frame: 5 months
Hospital Anxiety and Depression Scale (HAD)
Time frame: 5 months
SF-12 Health Survey (SF-12 Quality of Life Scale)
Time frame: 5 months
The Fatigue Severity Scale (FSS)
Time frame: 5 months
The Timed Up and Go (TUG)
Time frame: 5 months
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 12 Sep 2025.
- Individual participant dataSharing planned: No. Dataset sharing is not planned
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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.
Emre Ata, Asst. Prof. study director
Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital
Feyza Nur Yücel, Specialist study director
Health Sciences University Sultan 2.Abdülhamid Han 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 Fibromyalgia Syndrome and Central Sensitisation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 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. 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 Melike Ünsal Küçük, Principal Investigator (+90 537 739 62 00, melikeunsal463@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) Measurement with Algometer (time frame: 5 months). 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?
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 12 Sep 2025.