Carpal Tunnel SyndromeNCT02217293
Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
A study testing Pulsed Radiofrequency in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Pulsed Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Taipei, Neihu, 886
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Pulsed Radiofrequency
- Keywords
- Pulsed radiofrequency, Ultrasound-guided, Carpal tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RadiofrequencyDevice
Also called Neurotherm NT1000, Neurotherm Inc., USA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Measured: 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.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Measured: 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.
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.
Measured: 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.
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
Measured: Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
- Investigators
- Liang-Cheng Chen, MD, MS, Principal investigator, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217293
- Sponsor's protocol ID
- TSGHIRB: 1-101-05-049
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10815392O'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.
PubMed 12535461Katz 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.
PubMed 9708386Chua 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.
PubMed 21116663Werner 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.
PubMed 12169318Haider N, Mekasha D, Chiravuri S, Wasserman R. Pulsed radiofrequency of the median nerve under ultrasound guidance. Pain Physician. 2007 Nov;10(6):765-70.
PubMed 17987099Wong 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.
PubMed 12124876Chen 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.
PubMed 26067628
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02217293
- Acronym / sponsor ID
- TSGHIRB: 1-101-05-049
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Pulsed radiofrequency, Ultrasound-guided, Carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency | Active comparator | Device: Pulsed RadiofrequencyPulsed 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 |
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed RadiofrequencyAlso: Neurotherm NT1000, Neurotherm Inc., USAPulsed 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. | Device | Pulsed Radiofrequency |
Primary outcome
Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.
Time frame: Pre-treatment, 1st, 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.
4 secondary outcomes
Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Background: PubMed 10815392Atroshi 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.
- Background: PubMed 12535461O'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.
- Background: PubMed 9708386Katz 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.
- Background: PubMed 21116663Chua 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 publication: PubMed 12169318Werner 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 publication: PubMed 17987099Haider 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 publication: PubMed 12124876Wong 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.
- Derived from this study: PubMed 26067628Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Cheng Chen, MD, MS principal investigator
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment. (time frame: Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217293, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.