Clinical trial NCT02800187: The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Official title: The Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
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 dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed description: The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.

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 CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third 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 CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

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 cross-sectional area in median nerve 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: Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b.