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Carpal Tunnel Syndrome (CTS)NCT07433257

The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

An observational study of Carpal Tunnel Syndrome (CTS) and Type 2 Diabetes Mellitus (T2DM), run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2026to 31 Jul 2026
How long will I take part?
12 Weeks
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and were diagnosed with mild-to-moderate carpal tunnel syndrome

Who may be able to join

  • Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1):
  • Age between 18 and 75 years
  • Presence of clinical symptoms compatible with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months
  • Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings
  • Diagnosis of type 2 diabetes mellitus
  • Regulated blood glucose levels, defined as hemoglobin A1c (HbA1c) < 7%
Show all 11Show fewer
  • Idiopathic Carpal Tunnel Syndrome Group (Group 2):
  • Age between 18 and 75 years
  • Presence of clinical symptoms consistent with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months
  • Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings
  • No diagnosis of diabetes mellitus

Who cannot join

  • Severe carpal tunnel syndrome based on electrophysiological findings
  • Presence of polyneuropathy, cervical radiculopathy, brachial plexopathy, or thoracic outlet syndrome
  • Uncontrolled blood glucose levels in the diabetic group (hemoglobin A1c ≥ 7%)
  • Presence of another systemic disease, other than diabetes mellitus, that may cause carpal tunnel syndrome
  • Presence of a rheumatological disease
  • History of wrist surgery
Show all 11Show fewer
  • Less than 6 months since a local corticosteroid injection for carpal tunnel syndrome
  • Less than 3 months since completion of a physical therapy program for carpal tunnel syndrome
  • Infection at the intended injection site
  • Presence of malignancy
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elem Yorulmaz contact

elem_inal@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Haydarpasa Numune Training and Research Hospital

    Istanbul, Istanbul, 34668

    Talha Celik, MD, +905062398047, talhacelikdr@gmail.com

    Elem Yorulmaz, MD, elem_inal@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and who were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological findings and who received corticosteroid + local anesthetic injection will be included in the study. Data from patients who meet the inclusion and exclusion criteria will be included in the study. Patients' demographic and clinical data will be recorded. Records will be taken before treatment and at 4 and 12 weeks after treatment.

Read the detailed description

Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and were diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings, and who were indicated for interventional procedures and received corticosteroid + local anesthetic injections. Data from patients meeting the inclusion and exclusion criteria will be included in the study. Demographic and clinical data such as age, gender, height, weight, occupation, and dominant hand, as recorded in the patients' follow-up documents, will be recorded. In addition, the VAS (Visual Analog Scale), Tinel sign and Phalen test, Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), Median Nerve Cross-Sectional Area (MNCSA) measured by ultrasound, MNCSA measurement at the pisiform-scaphoid level, and electromyography (EMG)-nerve conduction study results will be noted. Patients will be divided into two groups: Group 1 (patients with Type 2 Diabetes Mellitus diagnosed with Carpal Tunnel Syndrome) and Group 2 (patients with Idiopathic Carpal Tunnel Syndrome). Details of the treatment administered before patients are included in the study will be as follows: Both groups will receive an injection containing corticosteroid + local anesthetic in the form of 1 milliliter (mL) of 40 milligrams (mg) [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride using the 'ulnar in-plane' technique guided by ultrasonography. All evaluation parameters (except electrophysiological evaluations) will be obtained from data recorded before treatment, at week 4 after treatment, and at week 12 after treatment. Electrophysiological parameters will be obtained from data recorded before treatment and at week 12 after treatment. Intra-group and inter-group differences will be statistically analyzed.

Being tested
1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride
Medical subject headings
Carpal Tunnel Syndrome, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochlorideDrug

    Both groups will receive an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride, administered using the 'ulnar in-plane' technique under ultrasound guidance.

Study groups in NCT07433257
Study groupRoleWhat they receive
Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1)Patients with mild-to-moderate carpal tunnel syndrome diagnosed by electrophysiological findings who also have a diagnosis of type 2 diabetes mellitus. Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.
Receives: Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride
Idiopathic Carpal Tunnel Syndrome Group (Group 2)Patients with mild-to-moderate idiopathic carpal tunnel syndrome diagnosed by electrophysiological findings, without a diagnosis of diabetes mellitus. Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.
Receives: Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain.

    Higher scores correspond to greater pain severity.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  2. Tinel Sign

    The Tinel sign will be conducted by a physician by percussing over the median nerve at the wrist.

    A positive sign is identified by the occurrence of tingling or "pins and needles" sensations in the palm, thumb, index finger, or middle finger.

    Findings will be documented as positive or negative.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  3. Phalen Test

    The Phalen test will be performed by a physician to assess median nerve compression.

    A positive test is defined as the reproduction of pain or paresthesia in the palmar region, thumb, index finger, or middle finger during sustained wrist flexion.

    Test results will be recorded as positive or negative.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  4. Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

    The Boston Carpal Tunnel Syndrome Questionnaire is a patient-reported outcome measure with two subscales: the Symptom Severity Scale and the Functional Status Scale.

    The Symptom Severity Scale includes 11 items assessing symptoms such as pain, paresthesia, numbness, weakness, nocturnal complaints, and difficulty grasping objects.

    The Functional Status Scale consists of 8 items evaluating hand-related functional abilities, including writing, buttoning clothes, holding a book while reading, gripping a telephone, opening jars, performing household activities, carrying shopping bags, and personal care tasks.

    Each item is scored on a 5-point Likert scale from 1 (no symptoms or no difficulty) to 5 (very severe symptoms or inability to perform the activity).

    Mean scores are calculated separately for each subscale, ranging from 1 to 5, with higher scores indicating greater symptom severity or poorer hand function.

    The validated Turkish version of the questionnaire was used.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  5. Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

    The Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) is a self-reported questionnaire used to evaluate neuropathic pain.

    Total scores range from 0 to 24, with higher scores indicating greater neuropathic pain severity.

    A score of 12 or higher is considered indicative of neuropathic pain. The validated Turkish version of the questionnaire will be used in this study

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  6. Hand Grip Strength

    Hand grip strength will be measured using a hand-held dynamometer . Three measurements will be obtained, and the mean value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  7. Pinch Strength

    Pinch strength will be assessed using a pinchmeter , including tip pinch, lateral pinch, and palmar pinch. Each measurement will be repeated three times, and the average value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

Secondary outcomes (7)
  1. Median Nerve Cross-Sectional Area (MNCSA)

    The Median Nerve Cross-Sectional Area (MNCSA) will be evaluated using ultrasonography at the level of the carpal tunnel inlet, defined anatomically by the scaphoid bone on the radial side and the pisiform bone on the ulnar side. The median nerve will be imaged in the transverse plane, and the cross-sectional area will be measured by manually tracing the hyperechoic epineurial border surrounding the nerve. Each measurement will be repeated three times, and the mean value will be used for analysis.

    Measured: before treatment, 4 weeks after treatment, 12 weeks after treatment

  2. Median Nerve Sensory Distal Latency

    Median nerve sensory distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between electrical stimulation and the recorded sensory response of the median nerve. Results will be reported in milliseconds (ms).

    Measured: before treatment, 12 weeks after treatment

  3. Median Sensory Nerve Action Potential Amplitude

    Median sensory nerve action potential amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the magnitude of the recorded sensory response of the median nerve following electrical stimulation. Results will be reported in microvolts (µV).

    Measured: before treatment, 12 weeks after treatment

  4. Median Nerve Sensory Conduction Velocity

    Median nerve sensory conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the sensory fibers of the median nerve. Results will be reported in meters per second (m/s).

    Measured: before treatment, 12 weeks after treatment

  5. Median Nerve Motor Distal Latency

    Median nerve motor distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between distal electrical stimulation and the recorded motor response of the median nerve. Results will be reported in milliseconds (ms).

    Measured: before treatment, 12 weeks after treatment

  6. Median Nerve Compound Muscle Action Potential Amplitude

    Median nerve compound muscle action potential (CMAP) amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS) following stimulation of the median nerve. The parameter represents the magnitude of the recorded motor response. Results will be reported in millivolts (mV).

    Measured: before treatment, 12 weeks after treatment

  7. Median Nerve Motor Conduction Velocity

    Median nerve motor conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the motor fibers of the median nerve. Results will be reported in meters per second (m/s).

    Measured: before treatment, 12 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start1 Mar 2026
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
Prospective
Enrolment
60 participants (estimated)
Target duration
12 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07433257
Sponsor's protocol ID
HNEAH-GOEK 2024/130
Status last verified
May 2026
First submitted
19 Nov 2025
Last updated
27 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS) and Type 2 Diabetes Mellitus (T2DM), run by Haydarpasa Numune Training and Research Hospital 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 11 inclusion and 11 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 27 May 2026. 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 TALHA ÇELİK (+905062398047, talhacelikdr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: before treatment, 4 weeks after treatment, 12 weeks after treatment). The study lists 7 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 27 May 2026.

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