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Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection in patients with CTS.
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd and 3rd month after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline hydrodissection | Experimental | Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve. |
|
| Normal saline | Placebo Comparator | Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided hydrodissection | Procedure | Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection | Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis. | Pre-treatment, 2nd week, 1st, 2nd and 3rd month after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of pain on 2nd week, 1st, 2nd and 3rd month after injection | Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain. | Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yung-Tsan Wu, MD | Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital | Taipei | Neihu District | 886 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18809959 | Result | Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485. | |
| 21234632 | Result | DeLea SL, Chavez-Chiang NR, Poole JL, Norton HE, Sibbitt WL Jr, Bankhurst AD. Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand. Clin Rheumatol. 2011 Jun;30(6):805-13. doi: 10.1007/s10067-010-1653-6. Epub 2011 Jan 15. |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000077324 | Crystalloid Solutions |
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| Placebo ultrasound-guided injection | Procedure | Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel |
|
| Ultrasound | Device |
|
| Normal Saline | Drug |
|
| Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd and 3rd month after injection |
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment. |
| Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection |
| Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd and 3rd month after injection | Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection |
| Change from baseline of finger pinch on 2nd week, 1st, 2nd and 3rd month after injection | The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch | Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection |
| 25932413 | Result | Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24. |
| 26218266 | Result | Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available. |
| 30339737 | Derived | Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |