Carpal Tunnel Syndrome(CTS)Phase 3NCT02575729
Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
A Phase 3 study testing betamethasone in people with Carpal Tunnel Syndrome(CTS), run by Chang Gung Memorial Hospital.
Trial summary
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome(CTS)
- What is being tested?
- betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jul 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with >2 following symptoms :
- disrupt sleep result in nocturnal paresthesia.
- symptoms release by shaking hand.
- pain and paresthesia during grasping.
- any sensory symptom on first, 2th, 3th and partial 4th fingers.
- symptoms >1month.
- Padua's classification : minimal, mild, moderate)
- meet one of three diagnosis criteria of carpal tunnel syndrome.
Who cannot join
- any history can cause periphery nerve disease.
- affected side had fracture or paralysis.
- had accepted operation for carpal tunnel syndrome before.
- pregnant
- wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
- Padua's classification: severe, extreme.
Show all 13Show fewer
- ultrasonography show space occupying.
- patient taking anticoagulants.
- severe systemic disease.
- wrist's skin or wrist joint has infection.
- can't complete the 6 months' follow up.
- allergy to steroid.
- has cognition disorder.
About this study
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).
Read the detailed description
Material and methods: We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.
- Conditions
- Carpal Tunnel Syndrome(CTS)
- Being tested
- betamethasone
- Keywords
- carpal tunnel syndrome, local steroid injection, sonography, sonography-guided
- 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.
betamethasoneDrug
Also called glucocorticoid preparation
Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
| Study group | Role | What they receive |
|---|---|---|
| Inject betamethasone by sonography | Experimental | Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand. Receives: Drug: betamethasone |
| Inject betamethasone directly | Active comparator | Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand. Receives: Drug: betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH
Measured: Change from Baseline data at 6 weeks
Secondary outcomes (6)
Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
Measured: Change from Baseline data at 6 weeks
Record the neurological symptoms perceived by patient after injection according to their describtion
Measured: Change from Baseline data at 6 weeks
Semmes-Weinstein Monofilament test(SWMT)
Measured: Change from Baseline data at 6 weeks
2-Point Discrimination test on 2nd digit
Measured: Change from Baseline data at 6 weeks
Nerve conduction study done on the affected hand using Necolet Viking Quest
We will record the latency, amplitude and conduction velocity retrieved from nerve conduction study of both motor neurons and sensory neuron
Measured: Change from Baseline data at 6 weeks
Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table
The test will done twice and will record the average data of both the cross-section area and the bowing distance of transverse ligament of wrist.
Measured: Change from Baseline data at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome(CTS)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pong Ya-Ping, MD, Study chair, Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575729
- Sponsor's protocol ID
- NMRPG8A0051
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Premoselli S, Sioli P, Grossi A, Cerri C. Neutral wrist splinting in carpal tunnel syndrome: a 3- and 6-months clinical and neurophysiologic follow-up evaluation of night-only splint therapy. Eura Medicophys. 2006 Jun;42(2):121-6.
PubMed 16767058Armstrong 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 14694502Dammers JW, Veering MM, Vermeulen M. Injection with methylprednisolone proximal to the carpal tunnel: randomised double blind trial. BMJ. 1999 Oct 2;319(7214):884-6. doi: 10.1136/bmj.319.7214.884.
PubMed 10506042Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
PubMed 19782873Irvine J, Chong SL, Amirjani N, Chan KM. Double-blind randomized controlled trial of low-level laser therapy in carpal tunnel syndrome. Muscle Nerve. 2004 Aug;30(2):182-7. doi: 10.1002/mus.20095.
PubMed 15266633Oztas O, Turan B, Bora I, Karakaya MK. Ultrasound therapy effect in carpal tunnel syndrome. Arch Phys Med Rehabil. 1998 Dec;79(12):1540-4. doi: 10.1016/s0003-9993(98)90416-6.
PubMed 9862296Weintraub MI, Cole SP. A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome. Pain Med. 2008 Jul-Aug;9(5):493-504. doi: 10.1111/j.1526-4637.2007.00324.x.
PubMed 18777606Breuer B, Sperber K, Wallenstein S, Kiprovski K, Calapa A, Snow B, Pappagallo M. Clinically significant placebo analgesic response in a pilot trial of botulinum B in patients with hand pain and carpal tunnel syndrome. Pain Med. 2006 Jan-Feb;7(1):16-24. doi: 10.1111/j.1526-4637.2006.00084.x.
PubMed 16533192Chang MH, Chiang HT, Lee SS, Ger LP, Lo YK. Oral drug of choice in carpal tunnel syndrome. Neurology. 1998 Aug;51(2):390-3. doi: 10.1212/wnl.51.2.390.
PubMed 9710008Hui AC, Wong SM, Wong KS, Li E, Kay R, Yung P, Hung LK, Yu LM. Oral steroid in the treatment of carpal tunnel syndrome. Ann Rheum Dis. 2001 Aug;60(8):813-4. doi: 10.1136/ard.60.8.813. No abstract available.
PubMed 11482310Wong SM, Hui AC, Tang A, Ho PC, Hung LK, Wong KS, Kay R, Li E. Local vs systemic corticosteroids in the treatment of carpal tunnel syndrome. Neurology. 2001 Jun 12;56(11):1565-7. doi: 10.1212/wnl.56.11.1565.
PubMed 11402116Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. doi: 10.1177/0269215507077294.
PubMed 17613571Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):981-1004. doi: 10.1016/j.apmr.2010.03.022.
PubMed 20599038Sevim S, Dogu O, Camdeviren H, Kaleagasi H, Aral M, Arslan E, Milcan A. Long-term effectiveness of steroid injections and splinting in mild and moderate carpal tunnel syndrome. Neurol Sci. 2004 Jun;25(2):48-52. doi: 10.1007/s10072-004-0229-0.
PubMed 15221621Kasten SJ, Louis DS. Carpal tunnel syndrome: a case of median nerve injection injury and a safe and effective method for injecting the carpal tunnel. J Fam Pract. 1996 Jul;43(1):79-82.
PubMed 8691185
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02575729
- Acronym / sponsor ID
- NMRPG8A0051
- Conditions
- Carpal Tunnel Syndrome(CTS)
- Keywords
- carpal tunnel syndrome, local steroid injection, sonography, sonography-guided
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Oct 2015 (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.
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).
Detailed description
Material and methods: We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inject betamethasone by sonography | Experimental | Drug: betamethasoneUse 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand. |
| Inject betamethasone directly | Active comparator | Drug: betamethasoneUse 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- with >2 following symptoms :
- symptoms >1month.
- Padua's classification : minimal, mild, moderate)
- meet one of three diagnosis criteria of carpal tunnel syndrome.
Key exclusion criteria (13 listed)
- any history can cause periphery nerve disease.
- affected side had fracture or paralysis.
- had accepted operation for carpal tunnel syndrome before.
- pregnant
- wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
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 |
|---|---|---|
| betamethasoneAlso: glucocorticoid preparationInject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly. | Drug | Inject betamethasone by sonography, Inject betamethasone directly |
Primary outcome
QuickDASH
Time frame: Change from Baseline data at 6 weeks
6 secondary outcomes
Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
Time frame: Change from Baseline data at 6 weeks
Record the neurological symptoms perceived by patient after injection according to their describtion
Time frame: Change from Baseline data at 6 weeks
Semmes-Weinstein Monofilament test(SWMT)
Time frame: Change from Baseline data at 6 weeks
2-Point Discrimination test on 2nd digit
Time frame: Change from Baseline data at 6 weeks
Nerve conduction study done on the affected hand using Necolet Viking Quest
Time frame: Change from Baseline data at 6 weeks
Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table
Time frame: Change from Baseline data at 6 weeks
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 Oct 2015.
- Background: PubMed 16767058Premoselli S, Sioli P, Grossi A, Cerri C. Neutral wrist splinting in carpal tunnel syndrome: a 3- and 6-months clinical and neurophysiologic follow-up evaluation of night-only splint therapy. Eura Medicophys. 2006 Jun;42(2):121-6.
- Background: 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.
- Background: PubMed 10506042Dammers JW, Veering MM, Vermeulen M. Injection with methylprednisolone proximal to the carpal tunnel: randomised double blind trial. BMJ. 1999 Oct 2;319(7214):884-6. doi: 10.1136/bmj.319.7214.884.
- Background: PubMed 19782873Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
- Background: PubMed 15266633Irvine J, Chong SL, Amirjani N, Chan KM. Double-blind randomized controlled trial of low-level laser therapy in carpal tunnel syndrome. Muscle Nerve. 2004 Aug;30(2):182-7. doi: 10.1002/mus.20095.
- Background: PubMed 9862296Oztas O, Turan B, Bora I, Karakaya MK. Ultrasound therapy effect in carpal tunnel syndrome. Arch Phys Med Rehabil. 1998 Dec;79(12):1540-4. doi: 10.1016/s0003-9993(98)90416-6.
- Background: PubMed 18777606Weintraub MI, Cole SP. A randomized controlled trial of the effects of a combination of static and dynamic magnetic fields on carpal tunnel syndrome. Pain Med. 2008 Jul-Aug;9(5):493-504. doi: 10.1111/j.1526-4637.2007.00324.x.
- Background: PubMed 16533192Breuer B, Sperber K, Wallenstein S, Kiprovski K, Calapa A, Snow B, Pappagallo M. Clinically significant placebo analgesic response in a pilot trial of botulinum B in patients with hand pain and carpal tunnel syndrome. Pain Med. 2006 Jan-Feb;7(1):16-24. doi: 10.1111/j.1526-4637.2006.00084.x.
- Background: PubMed 9710008Chang MH, Chiang HT, Lee SS, Ger LP, Lo YK. Oral drug of choice in carpal tunnel syndrome. Neurology. 1998 Aug;51(2):390-3. doi: 10.1212/wnl.51.2.390.
- Background: PubMed 11482310Hui AC, Wong SM, Wong KS, Li E, Kay R, Yung P, Hung LK, Yu LM. Oral steroid in the treatment of carpal tunnel syndrome. Ann Rheum Dis. 2001 Aug;60(8):813-4. doi: 10.1136/ard.60.8.813. No abstract available.
- Background: PubMed 11402116Wong SM, Hui AC, Tang A, Ho PC, Hung LK, Wong KS, Kay R, Li E. Local vs systemic corticosteroids in the treatment of carpal tunnel syndrome. Neurology. 2001 Jun 12;56(11):1565-7. doi: 10.1212/wnl.56.11.1565.
- Background: PubMed 17613571Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. doi: 10.1177/0269215507077294.
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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.
Pong Ya-Ping, MD study chair
Rehabilitation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing betamethasone in people with Carpal Tunnel Syndrome(CTS), run by Chang Gung Memorial Hospital.
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 8 inclusion and 13 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
QuickDASH (time frame: Change from Baseline data at 6 weeks). 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 NCT02575729, which also lists 19 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 Oct 2015.