Carpal Tunnel SyndromeNCT02990962
The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
A study testing 5% dextrose and 1cc 2% Xylocaine+4cc Triamcinolone (40mg) 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 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- 5% dextrose and 1cc 2% Xylocaine+4cc Triamcinolone (40mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to 1 Apr 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- 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 Versus Steroid in Patients With Carpal Tunnel Syndrome
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 including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.
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 steroid. 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 week, 1st, 2nd, 3rd and 6 month after the treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- 5% dextrose, 1cc 2% Xylocaine+4cc Triamcinolone (40mg)
- Keywords
- perineural injection, ultrasound-guided, dextrose, steroid
- 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.
5% dextroseDrug
Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.
1cc 2% Xylocaine+4cc Triamcinolone (40mg)Drug
Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.
| Study group | Role | What they receive |
|---|---|---|
| Perineural injection with 5% dextrose | Experimental | Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve. Receives: Drug: 5% dextrose |
| Perineural injection with steroid | Active comparator | Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve. Receives: Drug: 1cc 2% Xylocaine+4cc Triamcinolone (40mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary outcomes (3)
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the 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 week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Measured: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 54 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
- NCT02990962
- Sponsor's protocol ID
- PIT for CTS
- Status last verified
- Apr 2018
- First submitted
- 9 Dec 2016
- Last updated
- 24 Apr 2018
- 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 15920223Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.
PubMed 8482993Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.
PubMed 14694502
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02990962
- Acronym / sponsor ID
- PIT for CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- perineural injection, ultrasound-guided, dextrose, steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 13 Dec 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 including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.
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 steroid. 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 week, 1st, 2nd, 3rd and 6 month 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 | Drug: 5% dextroseUltrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve. |
| Perineural injection with steroid | Active comparator | Drug: 1cc 2% Xylocaine+4cc Triamcinolone (40mg)Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| 5% dextroseUltrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection. | Drug | Perineural injection with 5% dextrose |
| 1cc 2% Xylocaine+4cc Triamcinolone (40mg)Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection. | Drug | Perineural injection with steroid |
Primary outcome
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
3 secondary outcomes
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
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 24 Apr 2018.
- 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.
- Results publication: PubMed 8482993Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.
- Results publication: PubMed 14694502Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.
- 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 5% dextrose and 1cc 2% Xylocaine+4cc Triamcinolone (40mg) 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 24 Apr 2018. 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 on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment. (time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection). 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 NCT02990962, which also lists 5 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 24 Apr 2018.