Carpal Tunnel SyndromeNCT02809261
The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome
A study testing Ultrasound-guided perineural injection with 5% dextrose, Ultrasound-guided perineural injection with normal saline and Normal Saline 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 with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Ultrasound-guided perineural injection with 5% dextrose, Ultrasound-guided perineural injection with normal saline and Normal Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2016to 30 Mar 2017
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-85 year-old.
- Diagnosis was confirmed using an electrophysiological study and ultrasonography
Who cannot join
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886
About this study
Official title: The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
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. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.
Read the detailed description
After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound-guided perineural injection with 5% dextrose, Ultrasound-guided perineural injection with normal saline, Normal Saline, 5% Dextrose
- Keywords
- Carpal Tunnel Syndrome, Perineural injection, Dextrose
- 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.
Ultrasound-guided perineural injection with 5% dextroseProcedure or surgery
Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Ultrasound-guided perineural injection with normal salineProcedure or surgery
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Normal SalineDrug
Normal saline is safe for perineural injection.
5% DextroseDrug
5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
| Study group | Role | What they receive |
|---|---|---|
| Perineural injection with 5% dextrose | Experimental | Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve. Receives: Procedure: Ultrasound-guided perineural injection with 5% dextrose; Drug: 5% Dextrose |
| Perineural injection with normal saline | Placebo comparator | Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve. Receives: Procedure: Ultrasound-guided perineural injection with normal saline; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th 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, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary outcomes (2)
Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th 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, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Measured: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th 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 posted22 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809261
- Sponsor's protocol ID
- TSGHIRB No: 2-105-05-033
- Status last verified
- Dec 2017
- First submitted
- 10 Jun 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
PubMed 21623291Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.
PubMed 15138901Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.
PubMed 15920223Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
PubMed 28778254
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
- ClinicalTrials.gov ID
- NCT02809261
- Acronym / sponsor ID
- TSGHIRB No: 2-105-05-033
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Perineural injection, Dextrose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 22 Jun 2016 (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 with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.
Detailed description
After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural injection with 5% dextrose | Experimental | Procedure: Ultrasound-guided perineural injection with 5% dextrose, Drug: 5% DextroseUltrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve. |
| Perineural injection with normal saline | Placebo comparator | Procedure: Ultrasound-guided perineural injection with normal saline, Drug: Normal SalineUltrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-85 year-old.
- Diagnosis was confirmed using an electrophysiological study and ultrasonography
Key exclusion criteria (8 listed)
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
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 |
|---|---|---|
| Ultrasound-guided perineural injection with 5% dextroseUltrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection. | Procedure or surgery | Perineural injection with 5% dextrose |
| Ultrasound-guided perineural injection with normal salineUltrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection. | Procedure or surgery | Perineural injection with normal saline |
| Normal SalineNormal saline is safe for perineural injection. | Drug | Perineural injection with normal saline |
| 5% Dextrose5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation. | Drug | Perineural injection with 5% dextrose |
Primary outcome
Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Time frame: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
2 secondary outcomes
Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Time frame: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Time frame: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th 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 19 Dec 2017.
- Results publication: PubMed 21623291Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
- Results publication: PubMed 15138901Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.
- Results publication: PubMed 15920223Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.
- Derived from this study: PubMed 28778254Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
- Individual participant dataSharing planned: Yes
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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.
Yung-Tsan Wu, MD principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided perineural injection with 5% dextrose, Ultrasound-guided perineural injection with normal saline and Normal Saline 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 2 inclusion and 8 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 19 Dec 2017. 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. Some participants in this study may receive a placebo. 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 on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. (time frame: Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th 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 NCT02809261, which also lists 4 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 19 Dec 2017.