Musculoskeletal DiseasesNCT06243848
Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome
A study testing Minimal Incision Surgery for median nerve decompression and Ultrasound-guided perineural injection with 5 cc 5% Dextrose in people with Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome
- What is being tested?
- Minimal Incision Surgery for median nerve decompression and Ultrasound-guided perineural injection with 5 cc 5% Dextrose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 24 May 2026
- Phase
- Interventional
- 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
Who may be able to join
- The presence of symptoms such as nocturnal, posture-related, or movement-related paresthesias, along with possible pain, in the area supplied by the median nerve in the hand, lasting for more than 3 months.
- Confirmation of mild, moderate or severe CTS through electrophysiological testing.
- Numbness and loss of sensation in the hand's regions innervated by the median nerve, as well as weakness in the thenar muscles innervated by the median nerve.
- Positive results on either the Phalen test and/or Tinel sign.
Who cannot join
- Individuals who may exhibit symptoms mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- Patients who have received a previous injection into the carpal tunnel within the past 6 months.
- Thenar muscle atrophy.
- A history of prior carpal tunnel surgery.
- Regular usage of systemic nonsteroidal anti-inflammatory drugs and corticosteroids.
- Pregnancy
Show all 9Show fewer
- Patients diagnosed with rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, or polymyositis.
- Malignancy.
- Active infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
Ali İzzet AKÇİN, MD, +905469347374, dr.akcin93@gmail.com
Nuran EYVAZ, MD, +905334262442, n_eyvaz@hotmail.com
About this study
Official title: Comparison of Ultrasound-Guided Injection With Traditional Median Nerve Decompression Surgery in Patients With Carpal Tunnel Syndrome: Randomized Controlled Study
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome represents the most prevalent type of entrapment neuropathy. Anatomically, the carpal tunnel is formed by the carpal bones and lies beneath the transverse carpal ligament, housing nine tendon sheaths of the forearm flexors along with the median nerve. From a clinical perspective, individuals with carpal tunnel syndrome typically experience sensory symptoms such as paresthesia and hypoesthesia, as well as motor impairments and pain within the region supplied by the median nerve, all resulting from mechanical compression and localized ischemia.
In the classification of CTS, participants are diagnosed with mild, moderate, or severe CTS, and various treatment options are available for each category. Treatment options aimed at alleviating symptoms include physical therapy, splinting, wrist injections, and surgical procedures Ultrasound-guided injections of peripheral nerves are typically more advantageous than blind injections because minimize the risk of damaging crucial vascular structures in the adjacent tissue alongside the nerves and decrease the likelihood of intraneural injections.
CTS can also be treated surgically, although the literature has not provided sufficient evidence to establish the superiority of one surgical technique over another. However, these procedures are known to be effective by reducing the volume of the carpal tunnel, thereby relieving pressure on the median nerve. In CTS surgery, following a mini-incision, the dissection proceeds through fat and fascial tissue until the flexor retinaculum is reached, ensuring decompression of the median nerve. The advantages of the mini-incision technique include the preservation of neurovascular structures, a low risk of complications, and a high level of patient satisfaction, making it a prominent surgical approach.
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with the classic minimal incision surgical technique for median nerve decompression in participants diagnosed with mild, moderate, and severe carpal tunnel syndrome.
- Conditions
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Surgery
- Being tested
- Minimal Incision Surgery for median nerve decompression, Ultrasound-guided perineural injection with 5 cc 5% Dextrose
- Keywords
- Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Median Nerve Decompression
- Medical subject headings
- Musculoskeletal Diseases, Median Neuropathy, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Incision Surgery for median nerve decompressionProcedure or surgery
Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Ultrasound-guided perineural injection with 5 cc 5% DextroseProcedure or surgery
The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Incision Surgery for median nerve decompression | Active comparator | Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome. Receives: Procedure: Minimal Incision Surgery for median nerve decompression |
| Ultrasound-guided perineural injection with 5 cc 5% Dextrose | Experimental | The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve. Receives: Procedure: Ultrasound-guided perineural injection with 5 cc 5% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week
Pain intensity was assessed using a visual analogue scale for pain, ranging from 0 to 10 mm, where 0 indicates the absence of pain and 10 signifies intense pain. This scale is widely recognized for its strong reliability and validity in measuring musculoskeletal pain.
Measured: baseline and 12th week
Secondary outcomes (5)
Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th and 12th week
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a commonly used questionnaire for CTS, comprising two main components. It assesses severity using two categories: a symptom severity scale with 11 questions and a functional status scale with 8 questions. Each question is rated on a scale of 0 to 5, where 0 indicates no difficulties during the activity, and 5 indicates extremely severe dysfunction.
Measured: baseline and 12th week
Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th and 12th week
The median nerve's cross-sectional area (CSA) will be assessed at the scaphoid-pisiform level using an ultrasound. Three measurements will be taken, and the analysis will utilize the average of these three measurements.
CSA values increase as clinical findings worsen.
Measured: baseline and 12th week
Change from baseline Electrophysiological Evaluation at 4th and 12th week
Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be assessed for all patients. These measurements will be performed three times, and the resulting average value will be considered. CTS will be identified as mild, modarate or severe by electrophysiologic evaluations.
Measured: baseline and 12th week
Change from baseline Hand Grip Strength Assessment at 4th and 12th week
The participants' hand grip strength will be assessed using the "Jamar Hydrolic Hand Dynamometer." . Patients will be instructed to exert maximum force, and each measurement will be repeated three times, with the averages recorded in kilograms. Higher scores indicate better grip strength.
Measured: baseline and 12th week
Change from baseline Finger Grip Strength Assessment at 4th and 12th week
Finger grip strength will be evaluated using the "Jamar Digital Pinchmeter." Measurements will be taken bilaterally in three different hand positions: lateral, palmar, and fingertip grips. Higher average scores indicate better finger grip strength. The maximum force exerted during each trial in kilograms will be recorded.
Measured: baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start25 Jan 2024
- Primary completion24 Apr 2026 (estimated)
- Study completion24 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Eyvaz, Afyonkarahisar Health Sciences University
- Investigators
- Nuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityAli İzzet AKÇİN, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243848
- Sponsor's protocol ID
- CTSHDvsOP
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
PubMed 36980446Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.
PubMed 34065073Pace V, Marzano F, Placella G. Update on surgical procedures for carpal tunnel syndrome: What is the current evidence and practice? What are the future research directions? World J Orthop. 2023 Jan 18;14(1):6-12. doi: 10.5312/wjo.v14.i1.6. eCollection 2023 Jan 18.
PubMed 36686281
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Injection With Traditional Median Nerve Decompression Surgery in Patients With Carpal Tunnel Syndrome: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06243848
- Acronym / sponsor ID
- CTSHDvsOP
- Conditions
- Musculoskeletal Diseases, Median Nerve Disease, Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Surgery
- Keywords
- Carpal Tunnel Syndrome, Ultrasound-Guided Injection, Median Nerve Decompression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 May 2026 (estimated)
- First posted
- 6 Feb 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.
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome represents the most prevalent type of entrapment neuropathy. Anatomically, the carpal tunnel is formed by the carpal bones and lies beneath the transverse carpal ligament, housing nine tendon sheaths of the forearm flexors along with the median nerve. From a clinical perspective, individuals with carpal tunnel syndrome typically experience sensory symptoms such as paresthesia and hypoesthesia, as well as motor impairments and pain within the region supplied by the median nerve, all resulting from mechanical compression and localized ischemia.
In the classification of CTS, participants are diagnosed with mild, moderate, or severe CTS, and various treatment options are available for each category. Treatment options aimed at alleviating symptoms include physical therapy, splinting, wrist injections, and surgical procedures Ultrasound-guided injections of peripheral nerves are typically more advantageous than blind injections because minimize the risk of damaging crucial vascular structures in the adjacent tissue alongside the nerves and decrease the likelihood of intraneural injections.
CTS can also be treated surgically, although the literature has not provided sufficient evidence to establish the superiority of one surgical technique over another. However, these procedures are known to be effective by reducing the volume of the carpal tunnel, thereby relieving pressure on the median nerve. In CTS surgery, following a mini-incision, the dissection proceeds through fat and fascial tissue until the flexor retinaculum is reached, ensuring decompression of the median nerve. The advantages of the mini-incision technique include the preservation of neurovascular structures, a low risk of complications, and a high level of patient satisfaction, making it a prominent surgical approach.
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with the classic minimal incision surgical technique for median nerve decompression in participants diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Incision Surgery for median nerve decompression | Active comparator | Procedure: Minimal Incision Surgery for median nerve decompressionClassic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome. |
| Ultrasound-guided perineural injection with 5 cc 5% Dextrose | Experimental | Procedure: Ultrasound-guided perineural injection with 5 cc 5% DextroseThe median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The presence of symptoms such as nocturnal, posture-related, or movement-related paresthesias, along with possible pain, in the area supplied by the median nerve in the hand, lasting for more than 3 months.
- Confirmation of mild, moderate or severe CTS through electrophysiological testing.
- Numbness and loss of sensation in the hand's regions innervated by the median nerve, as well as weakness in the thenar muscles innervated by the median nerve.
- Positive results on either the Phalen test and/or Tinel sign.
Key exclusion criteria (9 listed)
- Individuals who may exhibit symptoms mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- Patients who have received a previous injection into the carpal tunnel within the past 6 months.
- Thenar muscle atrophy.
- A history of prior carpal tunnel surgery.
- Regular usage of systemic nonsteroidal anti-inflammatory drugs and corticosteroids.
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 |
|---|---|---|
| Minimal Incision Surgery for median nerve decompressionClassic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome. | Procedure or surgery | Minimal Incision Surgery for median nerve decompression |
| Ultrasound-guided perineural injection with 5 cc 5% DextroseThe median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve. | Procedure or surgery | Ultrasound-guided perineural injection with 5 cc 5% Dextrose |
Primary outcome
Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week
Time frame: baseline and 12th week
Pain intensity was assessed using a visual analogue scale for pain, ranging from 0 to 10 mm, where 0 indicates the absence of pain and 10 signifies intense pain. This scale is widely recognized for its strong reliability and validity in measuring musculoskeletal pain.
5 secondary outcomes
Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline Electrophysiological Evaluation at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline Hand Grip Strength Assessment at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline Finger Grip Strength Assessment at 4th and 12th week
Time frame: baseline and 12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 36980446Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
- Background: PubMed 34065073Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.
- Background: PubMed 36686281Pace V, Marzano F, Placella G. Update on surgical procedures for carpal tunnel syndrome: What is the current evidence and practice? What are the future research directions? World J Orthop. 2023 Jan 18;14(1):6-12. doi: 10.5312/wjo.v14.i1.6. eCollection 2023 Jan 18.
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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.
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
Ali İzzet AKÇİN, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Incision Surgery for median nerve decompression and Ultrasound-guided perineural injection with 5 cc 5% Dextrose in people with Musculoskeletal Diseases and Median Nerve Disease, run by Afyonkarahisar Health Sciences University 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 4 inclusion and 9 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 12 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?
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 Ali İzzet AKÇİN, MD (+905469347374, dr.akcin93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week (time frame: baseline and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243848, which also lists 3 linked publications.
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 12 Mar 2026.