The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

NCT ID: NCT02218229

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-05-31

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.

Conditions

Carpal Tunnel Syndrome

Keywords

shock wave; carpal tunnel syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Shock waves

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.

Group Type: EXPERIMENTAL

Shock wave

Intervention Type: 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

Night splint

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shock wave

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

Intervention Type: DEVICE

Other Intervention Names

E-SWT, Elettronica Pagani, Italy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yung-Tsan Wu

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yung-Tsan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Taipei, Neihu, Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 3336444 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11793180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11711214 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18002469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21856074 (View on PubMed)

Other Identifiers

TSGHIRB: 1-102-05-122

Identifier Type: -

Identifier Source: org_study_id