Comparing Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose in Carpal Tunnel Syndrome

NCT06400433 | Completed

• 1 other identifier: IstanbulUC-SKurtoglu-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; Median Nerve Entrapment; Entrapment Neuropathy

Keywords

Median nerve hydrodissection; Ultrasound guided injection

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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.

  Baseline, 2nd week, 4th week, 12th week

Secondary Outcomes (2)

• Change in hand grip strength values

  Baseline, 2nd week, 4th week, 12th week

• Change in two point discrimination test values

  Baseline, 2nd week, 4th week, 12th week

Study Arms (4)

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.

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.

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).

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).

Procedure: Ultrasound-guided median nerve hydrodissection

Interventions

Ultrasound-guided median nerve hydrodissection PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa (IUC)

Istanbul, Fatih, 34744, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 27751557 BACKGROUND

• Mondelli 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.

  PMID: 11805259 BACKGROUND

• Atroshi 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.

  PMID: 10411196 BACKGROUND

• Padua 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.

  PMID: 10563608 BACKGROUND

• Wong 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.

  PMID: 15155897 BACKGROUND

• Fowler 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.

  PMID: 20963527 BACKGROUND

• Padua 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.

  PMID: 9325471 BACKGROUND

• Padua 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.

  PMID: 8947287 BACKGROUND

• Jablecki 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.

  PMID: 8232399 BACKGROUND

• Ostergaard 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.

  PMID: 32124335 BACKGROUND

• Malone 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

• 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.

  PMID: 28622409 BACKGROUND

• Lin 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.

  PMID: 33391002 BACKGROUND

• Buntragulpoontawee 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.

  PMID: 33746745 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Sevgi S Kurtoglu, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Kenan Akgun, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Rana Terlemez, MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Jale Zare, MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient, the administering physician, the physician conducting the clinical and ultrasonographic evaluation, and the physician performing the electrophysiological examination will not be informed about the injection materials assigned to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency doctor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: May 13, 2024
• Primary Completion: September 23, 2024
• Study Completion: September 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)