Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

NCT ID: NCT02575729

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome(CTS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

betamethasone

Intervention Type DRUG

Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.

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.

Group Type ACTIVE_COMPARATOR

betamethasone

Intervention Type DRUG

Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

betamethasone

Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

glucocorticoid preparation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* with \>2 following symptoms :

1. disrupt sleep result in nocturnal paresthesia.
2. symptoms release by shaking hand.
3. pain and paresthesia during grasping.
4. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pong Ya-Ping, MD

Role: STUDY_CHAIR

Rehabilitation

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16767058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14694502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10506042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19782873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15266633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9862296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18777606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16533192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9710008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11482310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11402116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17613571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20599038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15221621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8691185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2320220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19097594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18465458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7000789 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NMRPG8A0051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.