Clinical Trial: Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome

Brief Summary:

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived.

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce.

The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.


Detailed Summary:

Background and Purpose:

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived.

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce. The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.

Study design Duration: 2012/1/1 to 2012/12/31. Subjects: 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. 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. Patient number: 40. Methods: The enrolled patients were randomized into two groups as the intervention group, who received one dose of PRF and the control group, who did not received RPF treatment by using drawing sealed envelope. To provide fundamental medical care of CTS, a wrist night splint was prescribed for each subject in both groups. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. All procedures were conducted by single physician. All the measurements were perfo
Sponsor: Tri-Service General Hospital

Current Primary Outcome: Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment. ]

Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 4th, 8th and 12th 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, 4th, 8th and 12th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 4th, 8th and 12th 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, 4th, 8th and 12th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 4th, 8th and 12th 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, 4th, 8th and 12th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 4th, 8th and 12th 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


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: August 12, 2014
Date Started: November 2012
Date Completion:
Last Updated: August 13, 2014
Last Verified: August 2014