Non-Invasive Targeted Electronic Pain Control Device ("Biowave System") Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Low back pain is a common condition, which extols a large cost to society from lost wages

      The Biowave System was developed by Biowave Corporation (Biowave), Norwalk, CT. Two wires
      emanate from the unit. The feed wire is attached to a large disposable input pad ("Feed
      Electrode"). The return wire is attached to a smaller pad ("Return Electrode") over the
      source of the pain (the treatment site).

      The device sends a premixed modulated envelope of two high frequency electronic wave forms
      ("Feed Signal") between the two electrodes. The beat frequency of the modulated envelope
      ("d-Frequency") is equal to the difference in frequency of the two feed signals. The location
      of beat frequency formation is dependent on the size and location of the two electrodes. With
      the configuration used in the study, the beat frequency signal is believed to form
      immediately ventrally to the Return electrode. The size of the volume of tissue affected can
      be changed and is dependent upon electrode geometry and the amplitude of the Feed Signal. The
      beat frequency is a low frequency blocking signal which is believed to cause a demodulation
      in the nerve cells and a reduction of the sodium/potassium ion exchange. As a result, the
      charge polarity of the nerve cell wall is prevented from changing and is therefore unable to
      transmit pain impulses. The size of the volume of tissue affected can be changed and is
      dependent upon electrode geometry and the amplitude of the Feed Signal.

      The objective of this study is to compare the Biowave System with TENS (a currently available
      treatment) and to further evaluate its efficacy for the relief of pain in patients with
      chronic low back pain.
    

Detailed description: 
      Background-Low back pain is a common, costly & often chronic condition, estimated to affect
      85% of people in their lifetime. A form of electronic pain control currently in use is TENS.
      Although the exact mechanism is not completely understood, it is proposed that its
      effectiveness is based on the gate control theory. Biowave has developed new patentable
      technology & a related device in the field of electromedicine. The device delivers a precise
      electrical signal to a specific volume of tissue in the body, which blocks the transmission
      of pain impulses.

      Treatment Plan-Treatment will be initiated with device indicated by the order to which the
      pt. was randomized. Pts. will be connected to one of two devices hidden from view by
      application of two small round two-inch diameter electrodes to the lower back.

      Baseline-A complete medical history & a physical examination will be performed. The pt. will
      complete a BPI questionnaire & be randomized to one of two treatment orders: 1) Biowave
      device followed by TENS device or 2) TENS device followed by Biowave Device. 2 treatment
      sessions will be separated by at least 72 hours.

      Treatment-Prior to each treatment session, pt. will complete initial VAS evaluations. Pt.'s
      ROM will be assessed & vital signs will be obtained. Pts. will complete VAS & categorical
      pain assessments at end of the 20 minute treatment period.

      Post-treatment-Pts. will repeat ROM test after device has been turned off & electrodes
      removed. VAS pain evaluations will be completed by the pt. at 30 & 60 minutes, vital signs &
      patient global impression of change will be obtained at 60 minutes following discontinuation
      of therapy. Pts. will be given VAS & categorical pain assessments to be completed at 4, 6,
      12, 24 and 48 hours & 1 week after treatment (to be returned by mail/fax) to assess possible
      long-term analgesic effects.
    

Intervention name(s): Biowave Targeted Non-Invasive Electronic Pain Control Device; TENS (Transcutaneous Electrical Nerve Stimulation) device
Intervention type(s): Device; Device
Intervention description(s): This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms ("Feed Signals") between two electrodes.; This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.
Other intervention name(s): Biowave; Empi's (St. Paul, MN) Epix XL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low Back Pain