Central Sensitization in Painful and Painless Diabetic Peripheral Neuropathy
ConditionDiabetes Mellitus (DM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorInonu University
About this trial
This research is structured as a cross-sectional observational study. The primary objective is to compare central sensitization across painful and painless phenotypes of diabetic peripheral neuropathy. The study will be conducted among individuals diagnosed with type 2 diabetes mellitus at the Department of Geriatrics, İnönü University Turgut Özal Medical Center. All assessments will be administered in accordance with a rigorously standardized protocol.
Eligible participants will include individuals aged 18 to 80 years who have had a confirmed diagnosis of type 2 diabetes mellitus for at least one year, are capable of comprehending and following verbal instructions in Turkish required for the study procedures, and provide written informed consent.
All statistical analyses will be performed using IBM SPSS Statistics (v.29, Armonk, NY, USA) and JASP (v.0.18, Amsterdam, Netherlands).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being between 18 and 80 years of age
Having a diagnosis of Type 2 diabetes mellitus for at least 1 year
Providing written informed consent to participate in the study
Disqualifiers
Non-diabetic causes of polyneuropathy (alcohol, chemotherapy, vitamin deficiencies, renal failure, hypothyroidism, etc.)
Active ulcer, infection, or severe vascular insufficiency in the lower extremity
Central nervous system disorders (stroke, multiple sclerosis, spinal cord injury, etc.)
Skin lesions, dermatitis, wounds, or infection in the test areas (foot or forearm)
Trial population
Individuals aged 18-80 who have had a diagnosis of Type 2 diabetes for at least 1 year will be included in this study.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
128 Participants
are grouped into 4 trial groupsGroup A: Painful DPN Group
Group B: Painless DPN Group
Group C: Diabetic Control Group Without Diabetic Peripheral Neuropathy (DPN)
Group D: Healthy Control Group
Trial outcomes
Primary outcomes
1
Conditioned Pain Modulation (CPM) Test
Assessment will be performed using an algometer. The algometer probe is positioned perpendicularly over the trapezius muscle. Pressure is increased at a rate of approximately 30 kPa/s. When the participant first perceives pain, the measurement is stopped and this value is recorded as PPT₁ (pre-test). Conditioning Stimulus (CS) - To evaluate ischemic pain, a blood pressure cuff is placed on the participant's non-dominant arm and rapidly inflated to 240 mmHg. The participant is then instructed to perform repeated hand-opening and closing exercises involving the distal arm (forearm muscles) for approximately 2 minutes. When the participant reports pain intensity as NRS ≥ 7/10, the conditioning stimulus is considered adequate. For the repeated PPT measurement, while the cuff remains inflated, PPT is measured again at the same location. This value is recorded as PPT₂ (post-test). The CPM effect is calculated using the formula: CPM effect = PPT₂ - PPT₁.
Time frame
Immediately before cuff inflation and immidiately after completion of the conditioning protocolSecondary outcomes
1
Central Sensitization Inventory (CSI)
The Central Sensitization Inventory (CSI) is a recently developed self-report screening tool designed to help identify patients with Central Sensitization Syndromes, including fibromyalgia. It consists of 25 items, each scored on a scale from 0 to 4, yielding a total score ranging from 0 to 100. Scores of 50 or higher indicate a very high level of central sensitization.
Time frame
Baseline(First assesstment2
DN4 (Douleur Neuropathique)
The DN4 (Douleur Neuropathique) questionnaire consists of sensory symptoms reported by the patient (7 items) and findings evaluated during physical examination (3 items). Each 'yes' response is scored as 1 point and each 'no' response as 0 points. The total score ranges from 0 to 10. A score of 4 or higher is considered indicative of neuropathic pain.
Time frame
Baseline(First assesstment)3
Michigan Neuropathy Screening Instrument (MNSI)
The Michigan Neuropathy Screening Instrument (MNSI) is a two-part scale used to assess diabetic neuropathy. The first part consists of questions completed by the patient, while the second part is based on the clinician's physical examination. Some items are scored as 'yes = 1 point, no = 0 points,' whereas the opposite scoring applies to certain other items. The maximum total score is 13, and scores of 7 or higher indicate a significant risk of symptomatic neuropathy.
Time frame
Baseline(First assesstment)4
Numerical Rating Scale (NRS)
Pain intensity will be assessed using the Numerical Rating Scale (NRS). The NRS is a unidimensional measure of pain severity primarily used in adults. Several versions exist, but the 11-point format is the most widely utilized. Using the NRS, patients report a number between 0 and 10 that best represents their pain intensity, where 0 indicates no pain and 10 represents the worst imaginable pain experienced within the past 24 hours.
Time frame
Baseline(First assesstment)Sponsors and contacts
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Source ClinicalTrials.gov
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