- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02575729
Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
October 12, 2015 updated by: Chang Gung Memorial Hospital
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inject betamethasone by sonography
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.
|
Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
Other Names:
|
Active Comparator: Inject betamethasone directly
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.
|
Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QuickDASH
Time Frame: Change from Baseline data at 6 weeks
|
Change from Baseline data at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS
Time Frame: Change from Baseline data at 6 weeks
|
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
|
Change from Baseline data at 6 weeks
|
|
Semmes-Weinstein Monofilament test(SWMT)
Time Frame: Change from Baseline data at 6 weeks
|
Change from Baseline data at 6 weeks
|
|
2-Point Discrimination test on 2nd digit
Time Frame: Change from Baseline data at 6 weeks
|
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
|
We will record the latency, amplitude and conduction velocity retrieved from nerve conduction study of both motor neurons and sensory neuron
|
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
|
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.
|
Change from Baseline data at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huisstede 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.
- Piazzini 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.
- Oztas 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.
- Jarvik 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.
- 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.
- Armstrong 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.
- Dammers 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.
- Irvine 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.
- Weintraub 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.
- Breuer 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.
- Chang 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.
- Hui 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.
- Wong 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.
- Sevim 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.
- Kasten 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.
- Linskey ME, Segal R. Median nerve injury from local steroid injection in carpal tunnel syndrome. Neurosurgery. 1990 Mar;26(3):512-5. doi: 10.1097/00006123-199003000-00021.
- Wang LY, Leong CP, Huang YC, Hung JW, Cheung SM, Pong YP. Best diagnostic criterion in high-resolution ultrasonography for carpal tunnel syndrome. Chang Gung Med J. 2008 Sep-Oct;31(5):469-76.
- Mondelli M, Filippou G, Aretini A, Frediani B, Reale F. Ultrasonography before and after surgery in carpal tunnel syndrome and relationship with clinical and electrophysiological findings. A new outcome predictor? Scand J Rheumatol. 2008 May-Jun;37(3):219-24. doi: 10.1080/03009740801914850.
- Gelberman RH, Aronson D, Weisman MH. Carpal-tunnel syndrome. Results of a prospective trial of steroid injection and splinting. J Bone Joint Surg Am. 1980 Oct;62(7):1181-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
September 17, 2015
First Submitted That Met QC Criteria
October 12, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Wounds and Injuries
- Disease
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Syndrome
- Carpal Tunnel Syndrome
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Glucocorticoids
Other Study ID Numbers
- NMRPG8A0051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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