Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

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 description: 
      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 performed by single physician who was blinded for the
      randomization, and the evaluation time was performed before intervention as well as the 1st,
      4th, 8th and 12th weeks after treatment. All patients were instructed to keep away from
      getting any other treatments for their pain or discomfort resulting from CTS including
      analgesic agents, injection or acupuncture etc. during the period of follow-up. They were
      asked to notify us if they had taken these therapies.

      Outcome measurements:

        1. Visual analog scale (VAS): The severity of digital pain during any activity most time
           per day was marked down in the pain scale. Each patient reported the VAS score every day
           at the same time after the initial treatment until 2 consecutive days reaching the
           definition of onset time which was defined as the day the VAS score had declined by 40%
           or more.

        2. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ).

        3. Cross-sectional area of the median nerve: It was measured at the proximal inlet of the
           carpal tunnel (level with the pisiform bone) by the same physician.

        4. Sensory nerve conduction velocity (SNCV) of median nerve.

        5. Finger pinch. Data analysis: Demographic data were analyzed by the Mann-Whitney U test
           for continuous data and X2 test for categorical data. Wilcoxon's signed rank test was
           used to compare the outcome measures within each group of patients. The outcomes at each
           follow-up period were compared with the baseline values and differences between both
           groups were investigated using the Mann-Whitney U test. Comparability of change of VAS
           score and finger pinch measurements among the two groups was assessed using Mann-Whitney
           U test. Statistical significance was set at p < 0.05.
    

Intervention name(s): Pulsed Radiofrequency
Intervention type(s): Device
Intervention description(s): Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. The ultrasound-guided PRF was performed before night splint in intervention group.
Other intervention name(s): Neurotherm NT1000, Neurotherm Inc., USA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulsed radiofrequency; Ultrasound-guided; Carpal tunnel syndrome