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The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shock wave
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring shock wave, carpal tunnel syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shock waves

Night splint

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline in cross-sectional area of the median nerve on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.
Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

Full Information

First Posted
August 13, 2014
Last Updated
October 10, 2017
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02218229
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
shock wave, carpal tunnel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shock waves
Arm Type
Experimental
Arm Description
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.
Arm Title
Night splint
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Shock wave
Other Intervention Name(s)
E-SWT, Elettronica Pagani, Italy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Title
Change from baseline in cross-sectional area of the median nerve on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Title
Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Description
The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Title
Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital, School of Medicine, National Defense Medical Center
City
Taipei
State/Province
Neihu
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
3336444
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.
Results Reference
background
PubMed Identifier
11793180
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.
Results Reference
background
PubMed Identifier
11711214
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.
Results Reference
background
PubMed Identifier
18002469
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.
Results Reference
background
PubMed Identifier
21856074
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.
Results Reference
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The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

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