The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

NCT02218229 | Completed DMC

• 1 other identifier: TSGHIRB: 1-102-05-122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

shock wave; carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

  Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

Secondary Outcomes (4)

• Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

• Change from baseline in cross-sectional area of the median nerve on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

• Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

• Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

Study Arms (2)

Shock waves

EXPERIMENTAL

Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.

Device: Shock wave

Night splint

NO INTERVENTION

The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study

Interventions

Shock wave DEVICE

Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis

Also known as: E-SWT, Elettronica Pagani, Italy

Shock waves

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Taipei, Neihu, 886, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 3336444 BACKGROUND

• 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.

  PMID: 11793180 BACKGROUND

• 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.

  PMID: 11711214 BACKGROUND

• 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.

  PMID: 18002469 BACKGROUND

• 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.

  PMID: 21856074 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yung-Tsan Wu, MD

  Tri-Service General Hospital, School of Medicine, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

TW (1)