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Clinical Trials in Turkey / NCT07316322
Starting soon Observational

Central Sensitization in Painful and Painless Diabetic Peripheral Neuropathy

NCT07316322 · tracked via the Priya Life Science Turkey tracker
Sponsor
Inonu University
Phase
Observational
Started
2025-12-15
Last updated
2026-01-05

Condition(s) studied

Diabetes Mellitus (DM)

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Peripheral entrapment neuropathies or related radiculopathies (e.g., carpal tunnel syndrome, C7-C8 radiculopathy) * Chronic widespread pain syndrome (fibromyalgia, etc.) or active flaring rheumatologic disease * Dose change within the last 2-4 weeks in medications affecting pain modulation (gabapentinoids, SNRI/TCA, opioids, hypnotics, etc.)

Primary outcome measure(s)

  • Conditioned Pain Modulation (CPM) Test — Immediately before cuff inflation and immidiately after completion of the conditioning protocol
    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.

Trial sites (1)

FacilityCityRegionStatus
Inonu University Turgut Ozal Medical Center, Malatya Malatya Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07316322 on ClinicalTrials.gov ↗ ← All trials in Turkey