Clinical trial NCT02801461: The Effect of ESWT for Cubital Tunnel Syndrome
Official title: The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 cubital tunnel syndrome.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
measure: Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
References:
citation: 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.
citation: 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.