The Effect of ESWT for Cubital Tunnel Syndrome

The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Device: extracorporeal shock wave therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neihu District
    • Taipei, Neihu District, Taiwan, 886
      • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-sessions of ESWT; ESWT was given once a week for 3 weeks.	Device: 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).
Active Comparator: One-session of ESWT; Single ESWT was given.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment	Visual analog scale (VAS)	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks	Using the Disabilities of the Arm, Shoulder and Hand to measure the symptoms and functional status before treatment and multiple time frame after treatment.	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks	electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Syndrome; Cubital Tunnel Syndrome
• Other Study ID Numbers: TSGHIRB: 2-105-05-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes