NCT02575729

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2011

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
Last Updated

October 15, 2015

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

September 17, 2015

Last Update Submit

October 12, 2015

Conditions

Carpal Tunnel Syndrome(CTS)

Keywords

carpal tunnel syndromelocal steroid injectionsonographysonography-guided

Outcome Measures

Primary Outcomes (1)

  • QuickDASH

    Change from Baseline data at 6 weeks

Secondary Outcomes (6)

  • Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS

    Change from Baseline data at 6 weeks

  • Record the neurological symptoms perceived by patient after injection according to their describtion

    Change from Baseline data at 6 weeks

  • Semmes-Weinstein Monofilament test(SWMT)

    Change from Baseline data at 6 weeks

  • 2-Point Discrimination test on 2nd digit

    Change from Baseline data at 6 weeks

  • Nerve conduction study done on the affected hand using Necolet Viking Quest

    Change from Baseline data at 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Drug: betamethasone

Interventions

betamethasoneDRUG

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

Also known as: glucocorticoid preparation
Inject betamethasone by sonographyInject betamethasone directly

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • 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.

    PMID: 16767058BACKGROUND

  • 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.

    PMID: 14694502BACKGROUND

  • 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.

    PMID: 10506042BACKGROUND

  • 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.

    PMID: 19782873BACKGROUND

  • 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.

    PMID: 15266633BACKGROUND

  • 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.

    PMID: 9862296BACKGROUND

  • 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.

    PMID: 18777606BACKGROUND

  • 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.

    PMID: 16533192BACKGROUND

  • 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.

    PMID: 9710008BACKGROUND

  • 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.

    PMID: 11482310BACKGROUND

  • 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.

    PMID: 11402116BACKGROUND

  • 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.

    PMID: 17613571BACKGROUND

  • 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.

    PMID: 20599038BACKGROUND

  • 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.

    PMID: 15221621BACKGROUND

  • 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.

    PMID: 8691185BACKGROUND

  • 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.

    PMID: 2320220BACKGROUND

  • 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.

    PMID: 19097594BACKGROUND

  • 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.

    PMID: 18465458BACKGROUND

  • 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.

    PMID: 7000789BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Pong Ya-Ping, MD

    Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

October 15, 2015

Study Start

August 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 15, 2015

Record last verified: 2015-09