The Effect of ESWT for Cubital Tunnel Syndrome

NCT ID: NCT02801461

Last Updated: 2018-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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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 cubital tunnel syndrome.

Detailed Description

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Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Conditions

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Cubital Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Three-sessions of ESWT

ESWT was given once a week for 3 weeks.

Group Type EXPERIMENTAL

extracorporeal shock wave therapy

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).

One-session of ESWT

Single ESWT was given.

Group Type ACTIVE_COMPARATOR

extracorporeal shock wave therapy

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).

Interventions

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extracorporeal shock wave therapy

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age between 20-80 year-old.
2. Typical symptoms and signs of cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria

1. Cancer
2. Coagulopathy
3. Pregnancy
4. Inflammation status
5. Patients who had conditions mimicking cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending physician of physical medicine and rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10.

Reference Type BACKGROUND
PMID: 26610183 (View on PubMed)

Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wustner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4.

Reference Type BACKGROUND
PMID: 21547883 (View on PubMed)

Other Identifiers

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TSGHIRB: 2-105-05-032

Identifier Type: -

Identifier Source: org_study_id

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