Carpal Tunnel Syndrome (CTS)NCT06725420
Ultrasound-Guided Injection vs Intramuscular Steroid for Carpal Tunnel Syndrome
A study testing Ultrasound-guided local Injection, Intramuscular Steroid Injection and Splinting in people with Carpal Tunnel Syndrome (CTS) and Chronic Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS) is the most common and disability-causing entrapment neuropathy; however, a standardized protocol for first-line management has yet to be established. Different treatment approaches have their own positive and negative aspects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Chronic Pain
- What is being tested?
- Ultrasound-guided local Injection, Intramuscular Steroid Injection and Splinting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Presence of typical CTS symptoms (numbness, tingling, paresthesias, or pain that may be provoked by nighttime or activity-related posture
- VAS score of ≥ 3/10
- Symptom duration longer than 12 weeks
- Positive Tinel's and/or Phalen's sign
- Electrophysiologically mild or moderate CTS being diagnosed.
- Volunteer to participate in study
Who cannot join
- Patients with shoulder, elbow, wrist, or finger problems (e.g., impingement syndrome, epicondylitis, history of fractures in the wrist, de Quervain's tenosynovitis, trigger finger, Complex Regional Pain Syndrome (CRPS), Dupuytren's contracture).
- Patients with a history of trauma or surgery in the affected hand, or those with significant anatomical deformities.
- Patients with systemic diseases such as rheumatological disorders, hypothyroidism, amyloidosis, diabetes, gout, or chronic kidney failure.
- Patients with conditions that may mimic CTS, such as polyneuropathy, plexopathy, cervical radiculopathy, or thoracic outlet syndrome.
- Patients with cognitive dysfunction or communication issues.
- Patients with severe CTS, neurological deficits (e.g., thenar atrophy, muscle weakness in thumb abduction/opposition), or those requiring surgical intervention.
Show all 15Show fewer
- Patients who have received local steroid injections or physical therapy to the hand/wrist within the last 6 months.
- Patients who are receiving or will receive another/additional treatment for CTS.
- Pregnant or lactating women.
- Patients with active malignancies or local/systemic infections.
- Patients who are receiving any active treatment (e.g., NSAIDs, oral/intramuscular steroids, acupuncture, other pain medications).
- Patients with upper extremity involvement due to first motor neuron damage (e.g., stroke-hemiplegia, tetraparesis, multiple sclerosis).
- Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.
- Use of a wrist splint during the last 6 months.
- Allergy to corticosteroids or local anesthetics, and blood diathesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Training and Research Hospital
Konya, 42060
About this study
Official title: Comparison of the Effectiveness of Ultrasound-guided Local Steroid Injection vs Intramuscular Steroid Injection in the Treatment of Carpal Tunnel Syndrome: A Prospective, Randomized, Controlled, Single-blind Study
Carpal tunnel syndrome (CTS) is the most common and disability-causing entrapment neuropathy; however, a standardized protocol for first-line management has yet to be established. Different treatment approaches have their own positive and negative aspects.
The aim of this study is to compare the effectiveness of ultrasound-guided local steroid injection and intramuscular steroid injection in mild-to-moderate CTS. Patients will be assessed for pain levels, functional/symptom status, hand-finger strength, side effects, patient satisfaction, median nerve ultrasonographic measurements, and EMG before and after treatment .
Read the detailed description
Patients evaluated through a detailed clinical examination and medical history review according to inclusion and exclusion criteria will provide written informed consent and will be assigned to one of three treatment groups using block randomization.
The patients' basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel's/Phalen's sign, sleep quality, pain intensity, electrophysiological parameters.) will be recorded.
The first group (local steroid) will receive an ultrasound-guided local steroid injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The second group (intramuscular steroid) will receive a gluteal intramuscular injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The third group will receive only a nighttime wrist splint. All patients in the study groups were provided with prefabricated volar wrist splints to be used at night and, whenever possible, during the day for 2-3 hours. No medication or exercise therapy will be given to the patients.
All groups were evaluated based on examination findings (Tinel's/Phalen's test), pain intensity (VAS day and VAS night), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire scores, sleep quality, the patient's subjective impression of improvement (satisfaction), electrophysiological parameters (two times), and ultrasound measurements (cross-sectional areas [CSA] and flattening ratio [long diameter/short diameter]) at the proximal inlet of the median nerve (at the level of the scaphoid and pisiform bones, at the level of the distal wrist crease) before treatment (baseline), at the end of treatment (two weeks), and six weeks after treatment. The evaluation parameters/outcomes will be made by the same researcher blind to the groups.
Patients will be questioned about undesirable effects at the end of the 2nd and 6th weeks after the treatment.
- Conditions
- Carpal Tunnel Syndrome (CTS), Chronic Pain
- Being tested
- Ultrasound-guided local Injection, Intramuscular Steroid Injection, Splinting
- Keywords
- Carpal tunnel syndrome, pain, Injection approach, Rehabilitation, Ultrasound-guided, Splints
- Medical subject headings
- Carpal Tunnel Syndrome, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided local InjectionOther
Also called wrist splint
Ultrasound-Guided steroid injection and splinting in patients with carpal tunnel syndrome
Intramuscular Steroid InjectionOther
Also called wrist splint
Intramuscular gluteal steroid injection and Splinting in Patients With Carpal Tunnel Syndrome
SplintingDevice
wrist night splint
| Study group | Role | What they receive |
|---|---|---|
| local steroid injection | Experimental | The group of patients who were injected with ultrasound-guided in-plane steroid and local anesthetic injection + wrist splint Receives: Other: Ultrasound-guided local Injection; Device: Splinting |
| intramuscular steroid injection | Experimental | The group of patients who received an intramuscular (gluteal) steroid and local anesthetic injection + wrist plint Receives: Other: Intramuscular Steroid Injection; Device: Splinting |
| Wrist splint | Experimental | The group of patients who received only a nighttime wrist splint Receives: Device: Splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
VAS pain day and night: 0 no pain; 10 unbearable/max. pain.
Measured: baseline, week 2 and week 6
The Boston Carpal Tunnel Syndrome Questionnaire
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
Measured: baseline, week 2 and week 6
Undesirable effects
Possible side effects such as nerve/vessel injury, bleeding, skin discoloration, fat atrophy, infection, allergy, steroid exacerbation (transient pain starting 24 hours after the injection and lasting a few days), hypertension, and steroid-induced edema will be questioned and recorded in the patients
Measured: Immediately, week 2 and week 6
Secondary outcomes (10)
Hand grip strength
Hand Grip Strength (HGS):
Following the definitions outlined in the literature, HGS will be measured using Jamar hand dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.
Measured: baseline, week 2 and week 6
Finger pinch strength
Finger Pinch Strength (FGS):
Following the definitions outlined in the literature, FGS will be measured using Baseline pinch dynamometers. The patients will be asked to squeeze the dynamometer three times with maximum strength, allowing 30-60 seconds of rest between each attempt. The average force (in pounds/kg) will then be recorded.
Measured: baseline, week 2 and week 6
Ultrasonographic evaluation of the median nerve
Ultrasonographic evaluation of the median nerve will be performed with a LA2-14A transducer /superficial linear probe (Samsung).
The cross-sectional areas (CSA) of the median nerve at the proximal inlet of the carpal tunnel will be recorded. To identify the entrance of the carpal tunnel, measurements will be taken at the level of the distal wrist crease, at the scaphoid and pisiform bones. The assessments were conducted with the patients seated, facing the clinician, with their elbow bent at approximately 90˚, forearm in a supine position, and fingers in a semiflexed posture. Measurements were obtained using the manual tracing feature of the ultrasound device, excluding the hyperechoic nerve sheathThe CSA (mm2) will be determined. The average of the three measurements will be recorded.
Measured: baseline, week 2 and week 6
Ultrasonographic evaluation of the median nerve
Ultrasonographic evaluation of the median nerve will be performed with a LA2-14A transducer /superficial linear probe (Samsung).
The flattening ratio (long diameter/short diameter) of the median nerve at the proximal inlet of the carpal tunnel will be recorded. To identify the entrance of the carpal tunnel, measurements will be taken at the level of the distal wrist crease, at the scaphoid and pisiform bones. The assessments were conducted with the patients seated, facing the clinician, with their elbow bent at approximately 90˚, forearm in a supine position, and fingers in a semiflexed posture. Measurements were obtained using the manual tracing feature of the ultrasound device, flattening ratio will be determined. The average of the three measurements will be recorded.
Measured: baseline, week 2 and week 6
Sleep quality
Sleep quality was evaluated using a single 4-point (0 = very bad, 3 = very good) Likert-type question from item 6 of the Pittsburgh Sleep Quality Index
Measured: Baseline, week 2 and week 6
Electrophysiological (nerve conduction) parameters
Electrophysiological parameters (median nerve distal motor latency) will be measured at two time points (baseline and week 6).
Measured: baseline and week 6
Electrophysiological (nerve conduction) parameters
Electrophysiological (nerve conduction) parameters (median sensory nerve distal latency) will be measured at two time points (baseline and week 6).
Measured: baseline and week 6
Electrophysiological (nerve conduction) parameters
Electrophysiological parameters (sensory and motor nerve conduction velocities) will be measured at two time points (baseline and week 6).
Measured: baseline and week 6
Electrophysiological (nerve conduction) parameters
Electrophysiological parameters (amplitudes of compound muscle action potential and sensory nerve action potential) will be measured at two time points (baseline and week 6).
Measured: baseline and week 6
Patient satisfaction
Patient satisfaction (Subjective impression of improvement):
Satisfaction levels of patients will be questioned. In the assessment consisting of five clauses with Likert-type scales, the clauses will be described as follows: 1, 'no satisfaction at all'; 2, 'no satisfaction'; 3, neutral (no positive or negative effect); 4, 'satisfied'; and 5, 'very satisfied'.
Measured: baseline, week 2 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start10 Dec 2024
- Primary completion19 Sep 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Yılmaz, MD, S.B. Konya Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725420
- Sponsor's protocol ID
- KonyaBeyhekimTRH2023/1075
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-guided Local Steroid Injection vs Intramuscular Steroid Injection in the Treatment of Carpal Tunnel Syndrome: A Prospective, Randomized, Controlled, Single-blind Study
- ClinicalTrials.gov ID
- NCT06725420
- Acronym / sponsor ID
- KonyaBeyhekimTRH2023/1075
- Conditions
- Carpal Tunnel Syndrome (CTS), Chronic Pain
- Keywords
- Carpal tunnel syndrome, pain, Injection approach, Rehabilitation, Ultrasound-guided, Splints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 10 Dec 2024 (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.
Carpal tunnel syndrome (CTS) is the most common and disability-causing entrapment neuropathy; however, a standardized protocol for first-line management has yet to be established. Different treatment approaches have their own positive and negative aspects.
The aim of this study is to compare the effectiveness of ultrasound-guided local steroid injection and intramuscular steroid injection in mild-to-moderate CTS. Patients will be assessed for pain levels, functional/symptom status, hand-finger strength, side effects, patient satisfaction, median nerve ultrasonographic measurements, and EMG before and after treatment .
Detailed description
Patients evaluated through a detailed clinical examination and medical history review according to inclusion and exclusion criteria will provide written informed consent and will be assigned to one of three treatment groups using block randomization.
The patients' basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel's/Phalen's sign, sleep quality, pain intensity, electrophysiological parameters.) will be recorded.
The first group (local steroid) will receive an ultrasound-guided local steroid injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The second group (intramuscular steroid) will receive a gluteal intramuscular injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The third group will receive only a nighttime wrist splint. All patients in the study groups were provided with prefabricated volar wrist splints to be used at night and, whenever possible, during the day for 2-3 hours. No medication or exercise therapy will be given to the patients.
All groups were evaluated based on examination findings (Tinel's/Phalen's test), pain intensity (VAS day and VAS night), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire scores, sleep quality, the patient's subjective impression of improvement (satisfaction), electrophysiological parameters (two times), and ultrasound measurements (cross-sectional areas [CSA] and flattening ratio [long diameter/short diameter]) at the proximal inlet of the median nerve (at the level of the scaphoid and pisiform bones, at the level of the distal wrist crease) before treatment (baseline), at the end of treatment (two weeks), and six weeks after treatment. The evaluation parameters/outcomes will be made by the same researcher blind to the groups.
Patients will be questioned about undesirable effects at the end of the 2nd and 6th weeks after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| local steroid injection | Experimental | Other: Ultrasound-guided local Injection, Device: SplintingThe group of patients who were injected with ultrasound-guided in-plane steroid and local anesthetic injection + wrist splint |
| intramuscular steroid injection | Experimental | Other: Intramuscular Steroid Injection, Device: SplintingThe group of patients who received an intramuscular (gluteal) steroid and local anesthetic injection + wrist plint |
| Wrist splint | Experimental | Device: SplintingThe group of patients who received only a nighttime wrist splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Presence of typical CTS symptoms (numbness, tingling, paresthesias, or pain that may be provoked by nighttime or activity-related posture
- VAS score of ≥ 3/10
- Symptom duration longer than 12 weeks
- Positive Tinel's and/or Phalen's sign
Key exclusion criteria (15 listed)
- Patients with shoulder, elbow, wrist, or finger problems (e.g., impingement syndrome, epicondylitis, history of fractures in the wrist, de Quervain's tenosynovitis, trigger finger, Complex Regional Pain Syndrome (CRPS), Dupuytren's contracture).
- Patients with a history of trauma or surgery in the affected hand, or those with significant anatomical deformities.
- Patients with systemic diseases such as rheumatological disorders, hypothyroidism, amyloidosis, diabetes, gout, or chronic kidney failure.
- Patients with conditions that may mimic CTS, such as polyneuropathy, plexopathy, cervical radiculopathy, or thoracic outlet syndrome.
- Patients with cognitive dysfunction or communication issues.
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 |
|---|---|---|
| Ultrasound-guided local InjectionAlso: wrist splintUltrasound-Guided steroid injection and splinting in patients with carpal tunnel syndrome | Other | local steroid injection |
| Intramuscular Steroid InjectionAlso: wrist splintIntramuscular gluteal steroid injection and Splinting in Patients With Carpal Tunnel Syndrome | Other | intramuscular steroid injection |
| Splintingwrist night splint | Device | Wrist splint, intramuscular steroid injection, local steroid injection |
Primary outcome
VAS pain
Time frame: baseline, week 2 and week 6
VAS pain day and night: 0 no pain; 10 unbearable/max. pain.
The Boston Carpal Tunnel Syndrome Questionnaire
Time frame: baseline, week 2 and week 6
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
Undesirable effects
Time frame: Immediately, week 2 and week 6
Possible side effects such as nerve/vessel injury, bleeding, skin discoloration, fat atrophy, infection, allergy, steroid exacerbation (transient pain starting 24 hours after the injection and lasting a few days), hypertension, and steroid-induced edema will be questioned and recorded in the patients
10 secondary outcomes
Hand grip strength
Time frame: baseline, week 2 and week 6
Finger pinch strength
Time frame: baseline, week 2 and week 6
Ultrasonographic evaluation of the median nerve
Time frame: baseline, week 2 and week 6
Ultrasonographic evaluation of the median nerve
Time frame: baseline, week 2 and week 6
Sleep quality
Time frame: Baseline, week 2 and week 6
Electrophysiological (nerve conduction) parameters
Time frame: baseline and week 6
Electrophysiological (nerve conduction) parameters
Time frame: baseline and week 6
Electrophysiological (nerve conduction) parameters
Time frame: baseline and week 6
Electrophysiological (nerve conduction) parameters
Time frame: baseline and week 6
Patient satisfaction
Time frame: baseline, week 2 and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided local Injection, Intramuscular Steroid Injection and Splinting in people with Carpal Tunnel Syndrome (CTS) and Chronic Pain, run by Konya Beyhekim 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 19 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: baseline, week 2 and week 6). 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 19 Mar 2026.