Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia

NCT06851091 | Recruiting

• 1 other identifier: 24/759
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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?
• 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?

Conditions

Fibromyalgia Syndrome; Central Sensitisation; Postural Balance

Keywords

Fibromyalgia; Central Sensitisation; Balance Changes; Postural Balance

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  5 months

Secondary Outcomes (10)

• Biodex Balance System

  5 months

• The Central Sensitization Inventory (CSI)

  5 months

• Numeric Rating Scale (NRS)

  5 months

• Revised Fibromyalgia Impact Questionnaire (FIQ)

  5 months

• S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)

  5 months

Study Arms (2)

Group 1 (Healthy volunteers)

Healthy volunteers without a diagnosis of Fibromyalgia Syndrome will be included in Group 1. (n=20)

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)

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)

Interventions

Biodex Balance System DIAGNOSTIC_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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

Pressure Pain Threshold (PPT) Measurement with Algometer DIAGNOSTIC_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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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)

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

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.

Group 1 (Healthy volunteers); Group 2 (Patients with fibromyalgia syndrome)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar

Istanbul, Üsküdar, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Emre Ata, Asst. Prof.

  Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital

  STUDY DIRECTOR

• Feyza Nur Yücel, Specialist

  Health Sciences University Sultan 2.Abdülhamid Han Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Melike Ünsal Küçük, Principal Investigator

CONTACT

+90 537 739 62 00; melikeunsal463@gmail.com

Feyza Nur Yücel, Specialist

CONTACT

+90 538 557 70 59; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: February 18, 2025
• Primary Completion: September 4, 2025
• Study Completion: December 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)