Carpal Tunnel SyndromeNCT06400433
Comparing Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose in Carpal Tunnel Syndrome
A study testing Ultrasound-guided median nerve hydrodissection in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the efficacy of ultrasonography-guided hydrodissection technique with 5% dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Median Nerve Entrapment, Entrapment Neuropathy
- What is being tested?
- Ultrasound-guided median nerve hydrodissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 30 Sep 2024
- 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
- Patients who are 18 years of age or older
- Patients who are clinically diagnosed with CTS
- Patients who have mild or moderate CTS confirmed by EMG study
- Patients unresponsive to 2-weeks of nightly volar wrist splinting
Who cannot join
- Patients who are younger than 18 years of age
- Patients with severe EMG study
- Presence of thenar atrophy
- Patients diagnosed with cervical radiculopathy, myelopathy, brachial plexopathy or polyneuropathy
- Patients diagnosed with thoracic outlet syndrome
- Patients diagnosed with inflammatory rheumatic disease
Show all 17Show fewer
- Patients diagnosed with connective tissue disease
- Patients diagnosed with neuromuscular disease
- Patients diagnosed with peripheral vascular disease
- Patients with history of malignancy
- Patients who have uncontrolled hypothyroidism, hyperthyroidism or diabetes mellitus
- Patients diagnosed with chronic renal failure
- Patients diagnosed with acromegaly
- Patients with history of surgery and/or fracture at the symptomatic upper extremity
- Patients with a history of injection into the median nerve lasting less than 6 months at the symptomatic wrist
- Patients who are pregnant
- Patients with history of chronic steroid or chronic alcohol use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa (IUC)
Istanbul, Fatih, 34744
About this study
Official title: Comparison of the Efficacy of Ultrasound-Guided Median Nerve Hydrodissection With Dexamethasone and Dextrose at Different Volumes in Patients With Carpal Tunnel Syndrome: A Prospective, Randomized, Double Blind Study
The aim of this study is to compare the efficacy of ultrasonography-guided hydrodissection technique with 5% dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment neuropathy worldwide, resulting from the compression of the median nerve in the carpal tunnel, an osteofibrous canal whose roof is formed by the flexor retinaculum and whose floor is formed by the carpal bones. CTS accounts for approximately 90% of all entrapment neuropathies, and an individual's lifetime risk of diagnosis is estimated to be 10%. It is estimated that about 5% of the population suffers from CTS. It is more common in women compared to men and at least half of the cases manifests between the ages of 40 and 60.
In clinical practice, the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve. These complaints, which initially occur and flare up at night and intermittently during the day, may become continuous and worsen in the later stages of the disease.
Taking an accurate history and clinical assessment is crucial for diagnosis. Evaluation of sensory abnormalities, loss of two point discrimination, and the strength of abductor pollicis brevis muscle can provide information about functional impairment. Tinel's sign and Phalen's manoeuvre are some of diagnostic tests. Some scales and questionnaires are used in diagnosis and assessment of functionality. Ultrasonography is a useful, inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy. Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage. Nerve conduction studies are considered the gold standard method in diagnosis, determining prognosis and making treatment decisions.
The management of CTS in patients depends on the severity of the disease. In mild and moderate circumstances conservative treatments are recommended for the patients. Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments. Conservative treatments include patient education, wrist splinting, medical treatments, physical therapy, and perineural injections.
Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS. This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid plane.Various injectates such as normal saline, 5% dextrose, and platelet-rich plasma,viscosupplements are commonly used for hydrodissection. Many studies have been conducted with the hypothesis that the injection volume, in addition to the injection preparation, would also be important in median nerve hydrodissection, and different results have been obtained.
This study aimed to compare the clinical, ultrasonographic and electrophysiological improvement in patients by applying different volumes of dexamethasone and dextrose in median nerve hydrodissection. Patients will be evaluated before and after treatment at 2nd, 4th and 12th weeks ultrasonographically, electrophysiologically and clinically with pain scores, handgrip strength assesment, two-point discrimination values, functional and disability scales.
- Being tested
- Ultrasound-guided median nerve hydrodissection
- Keywords
- Median nerve hydrodissection, Ultrasound guided injection
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided median nerve hydrodissectionProcedure or surgery
Injected wrist will be supinated and slightly dorsiflexed. The transducer of the ultrasound will be placed transversely at the proximal carpal inlet. After sterile preparation, a 22 gauge needle will be inserted using the short-axis technique, in-plane ulnar approach. During hydrodissection, separation of either between the median nerve and flexor retinaculum or between the median nerve and the underlying flexor tendons will be visually confirmed.
| Study group | Role | What they receive |
|---|---|---|
| 5 ml of %5 dextrose | Active comparator | The physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week.
Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 5 ml of %5 dextrose solution. Receives: Procedure: Ultrasound-guided median nerve hydrodissection |
| 10 ml of %5 dextrose | Active comparator | The physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week.
Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 10 ml of %5 dextrose solution. Receives: Procedure: Ultrasound-guided median nerve hydrodissection |
| 2 ml of 8 mg dexamethasone + 3 ml normal saline | Active comparator | The physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week.
Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 2 ml of 8 mg dexamethasone + 3 ml %0,9 NaCl solution (normal saline). Receives: Procedure: Ultrasound-guided median nerve hydrodissection |
| 2 ml of 8 mg dexamethasone + 8 ml normal saline | Active comparator | The physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week.
Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 2 ml of 8 mg dexamethasone + 8 ml %0,9 NaCl solution (normal saline). Receives: Procedure: Ultrasound-guided median nerve hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement measured by change in Numeric Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. Scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". Higher scores related to worse outcome.
Measured: Baseline, 2nd week, 4th week, 12th week
Functional and clinical improvement measured by change in Quick- Disabilities of Arm, Shoulder and Hand Questionnaire (Q-DASH) Scores
The Q-DASH questionnaire, which is a shortened version of the DASH questionnaire, consists of 11 items to measure physical functions and symptoms of the upper extremity. In order for the Q-DASH score to be calculated, at least 10 of the 11 topics must be answered. All items are scored between 1-5. In this scoring, 1 point indicates not having any difficulty during the activity, while 5 points indicates not being able to do the activity at all. Calculating the total score as 0 (zero) indicates no disability, while the highest score of 100 indicates the highest disability.
In our study, the investigator will use the Turkish form of the Q-DASH questionnaire, whose validity and reliability has been demonstrated.
Measured: Baseline, 2nd week, 4th week, 12th week
Change in median nerve cross-sectional area values
The median nerve cross-sectional area value will be measured by ultrasound at the proximal inlet of the carpal tunnel at the level of the os pisiforme and os hamatum.
Measured: Baseline, 2nd week, 4th week, 12th week
Functional and clinical improvement measured by change in Boston Carpal Tunnel Questionnaire (BCTQ)
It is a symptom and functionality assessment questionnaire for carpal tunnel syndrome developed by Levine et al. in 1993. It consists of two parts that evaluate symptom severity (Symptom Severity Scale) and functional status (Functional Status Scale). It consists of 11 questions about symptoms and 8 questions about functional status and has 5 possible answers. Each answer is scored between 1-5. The two sections are evaluated separately and the total score obtained. Minimum Symptom Severity Scale score is 11 and maximum score is 55. Minimum Functional Status Scale score is 8 and maximum score is 40. Calculating the total score as 19 (nineteen) indicates no disability, while the highest score of 95 (ninety five) indicates the highest disability.
In our study, the investigator will use the Turkish language version of BCTQ, the validity and reliability of which has been demonstrated.
Measured: Baseline, 2nd week, 4th week, 12th week
Change in median sensory nerve latency (SNL) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in median nerve distal motor latency (DML) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in median sensory nerve action potential (SNAP) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in median nerve compound muscle action potential (CMAP) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in median motor nerve conduction velocity (MNCV) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in median sensory nerve conduction velocity (SNCV) values from the electrophysiological study
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Measured: Baseline, 12th week
Change in 6-item CTS symptoms scale scores
It consists of 6 items. A special score was created for each item. The score of each item is calculated by addition. Minimum score is 0 (zero), maximum score is 26 (twenty six). Patients who score 12 points or more in total are highly expected to have CTS.
Measured: Baseline, 2nd week, 4th week, 12th week
Secondary outcomes (2)
Change in hand grip strength values
Measured by Jamar hand dynomometry, scored in kilograms, higher scores indicate better outcomes
Measured: Baseline, 2nd week, 4th week, 12th week
Change in two point discrimination test values
Measured 4-8 mm, higher than 5 mm score considered abnormal discrimination and higher scores indicates worse outcomes
Measured: Baseline, 2nd week, 4th week, 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 May 2024
- Study start13 May 2024
- Primary completion23 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Selin Kurtoglu, Istanbul University - Cerrahpasa
- Investigators
- Sevgi S Kurtoglu, MD, Principal investigator, Istanbul University - CerrahpasaKenan Akgun, MD, Study director, Istanbul University - CerrahpasaRana Terlemez, MD, Study chair, Istanbul University - CerrahpasaJale Zare, MD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400433
- Sponsor's protocol ID
- IstanbulUC-SKurtoglu-01
- Status last verified
- Jan 2025
- First submitted
- 1 May 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
PubMed 27751557Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
PubMed 11805259Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.
PubMed 10411196Padua L, Padua R, Lo Monaco M, Aprile I, Tonali P. Multiperspective assessment of carpal tunnel syndrome: a multicenter study. Italian CTS Study Group. Neurology. 1999 Nov 10;53(8):1654-9. doi: 10.1212/wnl.53.8.1654.
PubMed 10563608Wong SM, Griffith JF, Hui AC, Lo SK, Fu M, Wong KS. Carpal tunnel syndrome: diagnostic usefulness of sonography. Radiology. 2004 Jul;232(1):93-9. doi: 10.1148/radiol.2321030071. Epub 2004 May 20.
PubMed 15155897Fowler JR, Gaughan JP, Ilyas AM. The sensitivity and specificity of ultrasound for the diagnosis of carpal tunnel syndrome: a meta-analysis. Clin Orthop Relat Res. 2011 Apr;469(4):1089-94. doi: 10.1007/s11999-010-1637-5. Epub 2010 Oct 21.
PubMed 20963527Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
PubMed 9325471Padua L, LoMonaco M, Aulisa L, Tamburrelli F, Valente EM, Padua R, Gregori B, Tonali P. Surgical prognosis in carpal tunnel syndrome: usefulness of a preoperative neurophysiological assessment. Acta Neurol Scand. 1996 Nov;94(5):343-6. doi: 10.1111/j.1600-0404.1996.tb07077.x.
PubMed 8947287Jablecki CK, Andary MT, So YT, Wilkins DE, Williams FH. Literature review of the usefulness of nerve conduction studies and electromyography for the evaluation of patients with carpal tunnel syndrome. AAEM Quality Assurance Committee. Muscle Nerve. 1993 Dec;16(12):1392-414. doi: 10.1002/mus.880161220.
PubMed 8232399Ostergaard PJ, Meyer MA, Earp BE. Non-operative Treatment of Carpal Tunnel Syndrome. Curr Rev Musculoskelet Med. 2020 Apr;13(2):141-147. doi: 10.1007/s12178-020-09616-0.
PubMed 32124335Malone DG, Clark TB, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new technique. J Appl Res. (2010) 10:117.
Evers S, Thoreson AR, Smith J, Zhao C, Geske JR, Amadio PC. Ultrasound-guided hydrodissection decreases gliding resistance of the median nerve within the carpal tunnel. Muscle Nerve. 2018 Jan;57(1):25-32. doi: 10.1002/mus.25723. Epub 2017 Jul 6.
PubMed 28622409Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.
PubMed 33391002Buntragulpoontawee M, Chang KV, Vitoonpong T, Pornjaksawan S, Kitisak K, Saokaew S, Kanchanasurakit S. The Effectiveness and Safety of Commonly Used Injectates for Ultrasound-Guided Hydrodissection Treatment of Peripheral Nerve Entrapment Syndromes: A Systematic Review. Front Pharmacol. 2021 Mar 5;11:621150. doi: 10.3389/fphar.2020.621150. eCollection 2020.
PubMed 33746745
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound-Guided Median Nerve Hydrodissection With Dexamethasone and Dextrose at Different Volumes in Patients With Carpal Tunnel Syndrome: A Prospective, Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT06400433
- Acronym / sponsor ID
- IstanbulUC-SKurtoglu-01
- Keywords
- Median nerve hydrodissection, Ultrasound guided injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 May 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 the efficacy of ultrasonography-guided hydrodissection technique with 5% dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment neuropathy worldwide, resulting from the compression of the median nerve in the carpal tunnel, an osteofibrous canal whose roof is formed by the flexor retinaculum and whose floor is formed by the carpal bones. CTS accounts for approximately 90% of all entrapment neuropathies, and an individual's lifetime risk of diagnosis is estimated to be 10%. It is estimated that about 5% of the population suffers from CTS. It is more common in women compared to men and at least half of the cases manifests between the ages of 40 and 60.
In clinical practice, the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve. These complaints, which initially occur and flare up at night and intermittently during the day, may become continuous and worsen in the later stages of the disease.
Taking an accurate history and clinical assessment is crucial for diagnosis. Evaluation of sensory abnormalities, loss of two point discrimination, and the strength of abductor pollicis brevis muscle can provide information about functional impairment. Tinel's sign and Phalen's manoeuvre are some of diagnostic tests. Some scales and questionnaires are used in diagnosis and assessment of functionality. Ultrasonography is a useful, inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy. Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage. Nerve conduction studies are considered the gold standard method in diagnosis, determining prognosis and making treatment decisions.
The management of CTS in patients depends on the severity of the disease. In mild and moderate circumstances conservative treatments are recommended for the patients. Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments. Conservative treatments include patient education, wrist splinting, medical treatments, physical therapy, and perineural injections.
Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS. This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid plane.Various injectates such as normal saline, 5% dextrose, and platelet-rich plasma,viscosupplements are commonly used for hydrodissection. Many studies have been conducted with the hypothesis that the injection volume, in addition to the injection preparation, would also be important in median nerve hydrodissection, and different results have been obtained.
This study aimed to compare the clinical, ultrasonographic and electrophysiological improvement in patients by applying different volumes of dexamethasone and dextrose in median nerve hydrodissection. Patients will be evaluated before and after treatment at 2nd, 4th and 12th weeks ultrasonographically, electrophysiologically and clinically with pain scores, handgrip strength assesment, two-point discrimination values, functional and disability scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 ml of %5 dextrose | Active comparator | Procedure: Ultrasound-guided median nerve hydrodissectionThe physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week. Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 5 ml of %5 dextrose solution. |
| 10 ml of %5 dextrose | Active comparator | Procedure: Ultrasound-guided median nerve hydrodissectionThe physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week. Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 10 ml of %5 dextrose solution. |
| 2 ml of 8 mg dexamethasone + 3 ml normal saline | Active comparator | Procedure: Ultrasound-guided median nerve hydrodissectionThe physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week. Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 2 ml of 8 mg dexamethasone + 3 ml %0,9 NaCl solution (normal saline). |
| 2 ml of 8 mg dexamethasone + 8 ml normal saline | Active comparator | Procedure: Ultrasound-guided median nerve hydrodissectionThe physical examination, handgrip strength values, two-point discrimination, pain scoring (numeric rating scale), Q-DASH, BCTQ, CTS-6 scores, and ultrasonographically measured median nerve cross-sectional area values of the patients in this group will be evaluated and recorded by the first physician before the treatment and at the second, fourth, and twelfth weeks. The nerve conduction study will be examined by the second physician before the treatment and at the twelfth week. Patients in this group will be treated with ultrasound-guided median nerve hydrodissection by in-plane technique with 2 ml of 8 mg dexamethasone + 8 ml %0,9 NaCl solution (normal saline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 18 years of age or older
- Patients who are clinically diagnosed with CTS
- Patients who have mild or moderate CTS confirmed by EMG study
- Patients unresponsive to 2-weeks of nightly volar wrist splinting
Key exclusion criteria (17 listed)
- Patients who are younger than 18 years of age
- Patients with severe EMG study
- Presence of thenar atrophy
- Patients diagnosed with cervical radiculopathy, myelopathy, brachial plexopathy or polyneuropathy
- Patients diagnosed with thoracic outlet syndrome
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 median nerve hydrodissectionInjected wrist will be supinated and slightly dorsiflexed. The transducer of the ultrasound will be placed transversely at the proximal carpal inlet. After sterile preparation, a 22 gauge needle will be inserted using the short-axis technique, in-plane ulnar approach. During hydrodissection, separation of either between the median nerve and flexor retinaculum or between the median nerve and the underlying flexor tendons will be visually confirmed. | Procedure or surgery | 10 ml of %5 dextrose, 2 ml of 8 mg dexamethasone + 3 ml normal saline, 2 ml of 8 mg dexamethasone + 8 ml normal saline, 5 ml of %5 dextrose |
Primary outcome
Clinical improvement measured by change in Numeric Rating Scale
Time frame: Baseline, 2nd week, 4th week, 12th week
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. Scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". Higher scores related to worse outcome.
Functional and clinical improvement measured by change in Quick- Disabilities of Arm, Shoulder and Hand Questionnaire (Q-DASH) Scores
Time frame: Baseline, 2nd week, 4th week, 12th week
The Q-DASH questionnaire, which is a shortened version of the DASH questionnaire, consists of 11 items to measure physical functions and symptoms of the upper extremity. In order for the Q-DASH score to be calculated, at least 10 of the 11 topics must be answered. All items are scored between 1-5. In this scoring, 1 point indicates not having any difficulty during the activity, while 5 points indicates not being able to do the activity at all. Calculating the total score as 0 (zero) indicates no disability, while the highest score of 100 indicates the highest disability. In our study, the investigator will use the Turkish form of the Q-DASH questionnaire, whose validity and reliability has been demonstrated.
Change in median nerve cross-sectional area values
Time frame: Baseline, 2nd week, 4th week, 12th week
The median nerve cross-sectional area value will be measured by ultrasound at the proximal inlet of the carpal tunnel at the level of the os pisiforme and os hamatum.
Functional and clinical improvement measured by change in Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Baseline, 2nd week, 4th week, 12th week
It is a symptom and functionality assessment questionnaire for carpal tunnel syndrome developed by Levine et al. in 1993. It consists of two parts that evaluate symptom severity (Symptom Severity Scale) and functional status (Functional Status Scale). It consists of 11 questions about symptoms and 8 questions about functional status and has 5 possible answers. Each answer is scored between 1-5. The two sections are evaluated separately and the total score obtained. Minimum Symptom Severity Scale score is 11 and maximum score is 55. Minimum Functional Status Scale score is 8 and maximum score is 40. Calculating the total score as 19 (nineteen) indicates no disability, while the highest score of 95 (ninety five) indicates the highest disability. In our study, the investigator will use the Turkish language version of BCTQ, the validity and reliability of which has been demonstrated.
Change in median sensory nerve latency (SNL) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median nerve distal motor latency (DML) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median sensory nerve action potential (SNAP) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median nerve compound muscle action potential (CMAP) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median motor nerve conduction velocity (MNCV) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median sensory nerve conduction velocity (SNCV) values from the electrophysiological study
Time frame: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in 6-item CTS symptoms scale scores
Time frame: Baseline, 2nd week, 4th week, 12th week
It consists of 6 items. A special score was created for each item. The score of each item is calculated by addition. Minimum score is 0 (zero), maximum score is 26 (twenty six). Patients who score 12 points or more in total are highly expected to have CTS.
2 secondary outcomes
Change in hand grip strength values
Time frame: Baseline, 2nd week, 4th week, 12th week
Change in two point discrimination test values
Time frame: Baseline, 2nd week, 4th week, 12th week
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 31 Jan 2025.
- Background: PubMed 27751557Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
- Background: PubMed 11805259Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
- Background: PubMed 10411196Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.
- Background: PubMed 10563608Padua L, Padua R, Lo Monaco M, Aprile I, Tonali P. Multiperspective assessment of carpal tunnel syndrome: a multicenter study. Italian CTS Study Group. Neurology. 1999 Nov 10;53(8):1654-9. doi: 10.1212/wnl.53.8.1654.
- Background: PubMed 15155897Wong SM, Griffith JF, Hui AC, Lo SK, Fu M, Wong KS. Carpal tunnel syndrome: diagnostic usefulness of sonography. Radiology. 2004 Jul;232(1):93-9. doi: 10.1148/radiol.2321030071. Epub 2004 May 20.
- Background: PubMed 20963527Fowler JR, Gaughan JP, Ilyas AM. The sensitivity and specificity of ultrasound for the diagnosis of carpal tunnel syndrome: a meta-analysis. Clin Orthop Relat Res. 2011 Apr;469(4):1089-94. doi: 10.1007/s11999-010-1637-5. Epub 2010 Oct 21.
- Background: PubMed 9325471Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
- Background: PubMed 8947287Padua L, LoMonaco M, Aulisa L, Tamburrelli F, Valente EM, Padua R, Gregori B, Tonali P. Surgical prognosis in carpal tunnel syndrome: usefulness of a preoperative neurophysiological assessment. Acta Neurol Scand. 1996 Nov;94(5):343-6. doi: 10.1111/j.1600-0404.1996.tb07077.x.
- Background: PubMed 8232399Jablecki CK, Andary MT, So YT, Wilkins DE, Williams FH. Literature review of the usefulness of nerve conduction studies and electromyography for the evaluation of patients with carpal tunnel syndrome. AAEM Quality Assurance Committee. Muscle Nerve. 1993 Dec;16(12):1392-414. doi: 10.1002/mus.880161220.
- Background: PubMed 32124335Ostergaard PJ, Meyer MA, Earp BE. Non-operative Treatment of Carpal Tunnel Syndrome. Curr Rev Musculoskelet Med. 2020 Apr;13(2):141-147. doi: 10.1007/s12178-020-09616-0.
- BackgroundMalone DG, Clark TB, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new technique. J Appl Res. (2010) 10:117.
- Background: PubMed 28622409Evers S, Thoreson AR, Smith J, Zhao C, Geske JR, Amadio PC. Ultrasound-guided hydrodissection decreases gliding resistance of the median nerve within the carpal tunnel. Muscle Nerve. 2018 Jan;57(1):25-32. doi: 10.1002/mus.25723. Epub 2017 Jul 6.
- 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.
Sevgi S Kurtoglu, MD principal investigator
Istanbul University - Cerrahpasa
Kenan Akgun, MD study director
Istanbul University - Cerrahpasa
Rana Terlemez, MD study chair
Istanbul University - Cerrahpasa
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 median nerve hydrodissection in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Istanbul University - Cerrahpasa 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 17 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 31 Jan 2025. 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?
Clinical improvement measured by change in Numeric Rating Scale (time frame: Baseline, 2nd week, 4th week, 12th week). The study lists 11 primary outcomes in all. 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 NCT06400433, which also lists 14 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 31 Jan 2025.