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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02575729
Other study ID # NMRPG8A0051
Secondary ID
Status Completed
Phase Phase 3
First received September 17, 2015
Last updated October 12, 2015
Start date August 2011
Est. completion date July 2014

Study information

Verified date September 2015
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Linskey ME, Segal R. Median nerve injury from local steroid injection in carpal tunnel syndrome. Neurosurgery. 1990 Mar;26(3):512-5. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary QuickDASH Change from Baseline data at 6 weeks No
Secondary Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS Change from Baseline data at 6 weeks No
Secondary Record the neurological symptoms perceived by patient after injection according to their describtion Change from Baseline data at 6 weeks No
Secondary Semmes-Weinstein Monofilament test(SWMT) Change from Baseline data at 6 weeks No
Secondary 2-Point Discrimination test on 2nd digit Change from Baseline data at 6 weeks No
Secondary 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 Change from Baseline data at 6 weeks No
Secondary 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. Change from Baseline data at 6 weeks No