Clinical trial NCT02218229: The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome
Official title: The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: shock wave
carpal tunnel syndrome
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed description: Recently, many studies show the potential effect of shock wave for the reinnervation for peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the number of cases is relatively too small to make a conclusive remark. Large and well-designed study would expand the new field.

Eligibility criteria: Inclusion Criteria:

Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled.

Exclusion Criteria:

The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS, were all excluded.

Primary outcomes:
measure: Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Secondary outcomes:
measure: Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
measure: Change from baseline in cross-sectional area of the median nerve on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
measure: Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
measure: Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, School of Medicine, National Defense Medical Center
state: Neihu
Study officials:
affiliation: Tri-Service General Hospital, School of Medicine, National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens JC, Sun S, Beard CM, O'Fallon WM, Kurland LT. Carpal tunnel syndrome in Rochester, Minnesota, 1961 to 1980. Neurology. 1988 Jan;38(1):134-8. doi: 10.1212/wnl.38.1.134.
citation: Orhan Z, Alper M, Akman Y, Yavuz O, Yalciner A. An experimental study on the application of extracorporeal shock waves in the treatment of tendon injuries: preliminary report. J Orthop Sci. 2001;6(6):566-70. doi: 10.1007/s007760100013.
citation: Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, Wada Y, Takahashi K, Yamagata M, Moriya H. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001 Nov 23;315(1-2):57-60. doi: 10.1016/s0304-3940(01)02320-5.
citation: Wu YH, Lun JJ, Chen WS, Chong FC. The electrophysiological and functional effect of shock wave on peripheral nerves. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:2369-72. doi: 10.1109/IEMBS.2007.4352803.
citation: Romeo P, d'Agostino MC, Lazzerini A, Sansone VC. Extracorporeal shock wave therapy in pillar pain after carpal tunnel release: a preliminary study. Ultrasound Med Biol. 2011 Oct;37(10):1603-8. doi: 10.1016/j.ultrasmedbio.2011.07.002. Epub 2011 Aug 19.