Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome

NCT02217293 | Completed DMC

• 1 other identifier: TSGHIRB: 1-101-05-049
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived. Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce. The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.

Conditions

Carpal Tunnel Syndrome

Keywords

Pulsed radiofrequency; Ultrasound-guided; Carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.

  Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

  Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

Secondary Outcomes (4)

• Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.

  Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

• Change from baseline in cross-sectional area of the median nerve on 1st, 4th, 8th and 12th weeks after treatment.

  Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

• Change from baseline in conduction velocity, ampliture of median nerve on 1st, 4th, 8th and 12th weeks after treatment.

  Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

• Change from baseline in finger pinch on 1st, 4th, 8th and 12th weeks after treatment.

  Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.

Study Arms (2)

Pulsed Radiofrequency

ACTIVE COMPARATOR

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury

Device: Pulsed Radiofrequency

Night splint

NO INTERVENTION

The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study

Interventions

Pulsed Radiofrequency DEVICE

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. The ultrasound-guided PRF was performed before night splint in intervention group.

Also known as: Neurotherm NT1000, Neurotherm Inc., USA

Pulsed Radiofrequency

Eligibility Criteria

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

You may qualify if:

• Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled.

You may not qualify if:

• The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Taipei, Neihu, 886, Taiwan

Location

Related Publications (8)

• Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. [Prevalence for clinically proved carpal tunnel syndrome is 4 percent]. Lakartidningen. 2000 Apr 5;97(14):1668-70. Swedish.

  PMID: 10815392 BACKGROUND

• O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.

  PMID: 12535461 BACKGROUND

• Katz JN, Keller RB, Simmons BP, Rogers WD, Bessette L, Fossel AH, Mooney NA. Maine Carpal Tunnel Study: outcomes of operative and nonoperative therapy for carpal tunnel syndrome in a community-based cohort. J Hand Surg Am. 1998 Jul;23(4):697-710. doi: 10.1016/S0363-5023(98)80058-0.

  PMID: 9708386 BACKGROUND

• Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30.

  PMID: 21116663 BACKGROUND

• Werner RA, Andary M. Carpal tunnel syndrome: pathophysiology and clinical neurophysiology. Clin Neurophysiol. 2002 Sep;113(9):1373-81. doi: 10.1016/s1388-2457(02)00169-4.

  PMID: 12169318 RESULT

• Haider N, Mekasha D, Chiravuri S, Wasserman R. Pulsed radiofrequency of the median nerve under ultrasound guidance. Pain Physician. 2007 Nov;10(6):765-70.

  PMID: 17987099 RESULT

• Wong SM, Griffith JF, Hui AC, Tang A, Wong KS. Discriminatory sonographic criteria for the diagnosis of carpal tunnel syndrome. Arthritis Rheum. 2002 Jul;46(7):1914-21. doi: 10.1002/art.10385.

  PMID: 12124876 RESULT

• Chen LC, Ho CW, Sun CH, Lee JT, Li TY, Shih FM, Wu YT. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study. PLoS One. 2015 Jun 12;10(6):e0129918. doi: 10.1371/journal.pone.0129918. eCollection 2015.

  PMID: 26067628 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Pulsed Radiofrequency Treatment

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)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Liang-Cheng Chen, MD, MS

  Tri-Service General Hospital, School of Medicine, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

TW (1)