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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217293
• Other study ID #: TSGHIRB: 1-101-05-049
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: August 13, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

Background and Purpose:

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.

Study design Duration: 2012/1/1 to 2012/12/31. Subjects: 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. 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, were all excluded. Patient number: 40. Methods: The enrolled patients were randomized into two groups as the intervention group, who received one dose of PRF and the control group, who did not received RPF treatment by using drawing sealed envelope. To provide fundamental medical care of CTS, a wrist night splint was prescribed for each subject in both groups. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. All procedures were conducted by single physician. All the measurements were performed by single physician who was blinded for the randomization, and the evaluation time was performed before intervention as well as the 1st, 4th, 8th and 12th weeks after treatment. All patients were instructed to keep away from getting any other treatments for their pain or discomfort resulting from CTS including analgesic agents, injection or acupuncture etc. during the period of follow-up. They were asked to notify us if they had taken these therapies.

Outcome measurements:

1. Visual analog scale (VAS): The severity of digital pain during any activity most time per day was marked down in the pain scale. Each patient reported the VAS score every day at the same time after the initial treatment until 2 consecutive days reaching the definition of onset time which was defined as the day the VAS score had declined by 40% or more.

2. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ).

3. Cross-sectional area of the median nerve: It was measured at the proximal inlet of the carpal tunnel (level with the pisiform bone) by the same physician.

4. Sensory nerve conduction velocity (SNCV) of median nerve.

5. Finger pinch. Data analysis: Demographic data were analyzed by the Mann-Whitney U test for continuous data and X2 test for categorical data. Wilcoxon's signed rank test was used to compare the outcome measures within each group of patients. The outcomes at each follow-up period were compared with the baseline values and differences between both groups were investigated using the Mann-Whitney U test. Comparability of change of VAS score and finger pinch measurements among the two groups was assessed using Mann-Whitney U test. Statistical significance was set at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Pulsed Radiofrequency
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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, School of Medicine, National Defense Medical Center	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Hand Surg [Am] 1999 Jan;24(1):201. — View Citation

O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;(1):CD003219. Review. — View Citation

Werner RA, Andary M. Carpal tunnel syndrome: pathophysiology and clinical neurophysiology. Clin Neurophysiol. 2002 Sep;113(9):1373-81. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.	Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.	Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.	No
Secondary	Change from baseline in cross-sectional area of the median nerve on 1st, 4th, 8th and 12th weeks after treatment.	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.	Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.	No
Secondary	Change from baseline in conduction velocity, ampliture of median nerve on 1st, 4th, 8th and 12th weeks after treatment.	The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.	Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.	No
Secondary	Change from baseline in finger pinch on 1st, 4th, 8th and 12th weeks after treatment.	The finger pinch strength was measured using Jamar 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, 1st, 4th, 8th and 12th weeks after treatment.	No