The Effect of Hydrodissection for Carpal Tunnel Syndrome

NCT02991001 | Completed DMC

• 1 other identifier: Hydrodissection for CTS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

Hydrodissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline of pain on 2nd week, 1st, 2nd and 3rd month after injection

  Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection

• Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd and 3rd month after injection

  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

  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

  Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection

Study Arms (2)

Normal saline hydrodissection

EXPERIMENTAL

Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.

Procedure: Ultrasound-guided hydrodissection; Device: Ultrasound; Drug: Normal Saline

Normal saline

PLACEBO COMPARATOR

Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region

Procedure: Placebo ultrasound-guided injection; Device: Ultrasound; Drug: Normal Saline

Interventions

Ultrasound-guided hydrodissection PROCEDURE

Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.

Normal saline hydrodissection

Placebo ultrasound-guided injection PROCEDURE

Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Normal saline

Ultrasound DEVICE

Normal saline; Normal saline hydrodissection

Normal Saline DRUG

Normal saline; Normal saline hydrodissection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-80 year-old.
• Diagnosis was confirmed using an electrophysiological study

You may not qualify if:

• Cancer
• Coagulopathy
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid injection for CTS

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 18809959 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.

  PMID: 21234632 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.

  PMID: 25932413 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.

  PMID: 26218266 RESULT

• 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.

  PMID: 30339737 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography; Saline Solution

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: January 1, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)