The Effect of Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of Hydrodissection for Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991001
• Other study ID #: Hydrodissection for CTS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: July 2018
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 20-80 year-old.

• Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

• Cancer

• Coagulopathy

• Pregnancy

• Inflammation status

• Cervical radiculopathy

• Polyneuropathy, brachial plexopathy

• Thoracic outlet syndrome

• Previously undergone wrist surgery or steroid injection for CTS

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Ultrasound-guided hydrodissection
Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
• Placebo ultrasound-guided injection
Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Device:
• Ultrasound

Drug:
• Normal Saline

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Chang KV, Hung CY, Özçakar 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. — View Citation

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 201 — View Citation

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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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