Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pulsed Radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Pulsed radiofrequency, Ultrasound-guided, Carpal tunnel syndrome
Eligibility Criteria
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
Sites / Locations
- Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pulsed Radiofrequency
Night splint
Arm Description
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 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT02217293
First Posted
August 12, 2014
Last Updated
August 13, 2014
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02217293
Brief Title
Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
Official Title
Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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:
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.
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ).
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.
Sensory nerve conduction velocity (SNCV) of median nerve.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Pulsed radiofrequency, Ultrasound-guided, Carpal tunnel syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Radiofrequency
Arm Type
Active Comparator
Arm Description
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
Arm Title
Night splint
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pulsed Radiofrequency
Other Intervention Name(s)
Neurotherm NT1000, Neurotherm Inc., USA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Title
Change from baseline in cross-sectional area of the median nerve on 1st, 4th, 8th and 12th weeks after treatment.
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Time Frame
Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Title
Change from baseline in conduction velocity, ampliture of median nerve on 1st, 4th, 8th and 12th weeks after treatment.
Description
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.
Time Frame
Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Title
Change from baseline in finger pinch on 1st, 4th, 8th and 12th weeks after treatment.
Description
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
Time Frame
Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Cheng Chen, MD, MS
Organizational Affiliation
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
City
Taipei
State/Province
Neihu
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
10815392
Citation
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.
Results Reference
background
PubMed Identifier
12535461
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;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
Results Reference
background
PubMed Identifier
9708386
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. doi: 10.1016/S0363-5023(98)80058-0. Erratum In: J Hand Surg [Am] 1999 Jan;24(1):201.
Results Reference
background
PubMed Identifier
21116663
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.
Results Reference
background
PubMed Identifier
12169318
Citation
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.
Results Reference
result
PubMed Identifier
17987099
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.
Results Reference
result
PubMed Identifier
12124876
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. doi: 10.1002/art.10385.
Results Reference
result
PubMed Identifier
26067628
Citation
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.
Results Reference
derived
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Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
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