TENS Effectiveness and Knee Osteoarthritis in Humans
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      TENS is a non pharmacological intervention to control pain. Both high (>50 Hz) and low (<10
      Hz) frequency TENS are used in the clinic and it is thought that each type works through
      different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased
      response to a noxious stimuli, is one component of pain and occurs both at the site of
      injury, primary hyperalgesia, and outside the site of injury, secondary hyperalgesia. Recent
      studies in animals with arthritis of the knee show that low and high frequency TENS
      differentially modulate primary and secondary hyperalgesia.

      Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with
      movement resulting in increased function.
    

Detailed description: 
      The following specific aims will address this hypothesis:

      Specific Aim 1 will compare the effect of high frequency TENS, low frequency TENS, and
      placebo TENS in patients with osteoarthritis on a variety of outcome measures: primary and
      secondary hyperalgesia, subjective pain scores, and function.

      Specific Aim 2 will determine the relationships among these multiple pain measures in people
      with osteoarthritis, and compare to age matched controls.

      Specific Aim 3 will determine the genetic variability as it relates to osteoarthritis pain
      and response to TENS treatment

      Specific Aim 4 will determine how body composition (BMI, fat mass, percent fat, lean mass,
      and bone mass) impacts the effectiveness of TENS

      One of the long-term goals of the investigators is to determine the clinical effectiveness of
      non-pharmacological treatments for pain, like TENS. These studies will begin to address this
      issue by examining effects of TENS on a variety of outcome measures in patients with a
      specific controlled condition (i.e., knee osteoarthritis). This research is innovative
      because it will be the first to systematically examine the effects of TENS on a variety of
      physiological parameters (primary and secondary hyperalgesia) and clinical outcome measures
      (resting pain, movement-evoked pain, function) in a common, painful and limiting condition
      that is frequently seen in physical therapy clinics. These studies will further allow us to
      translate basic science experiments previously performed in animal models of arthritis to the
      clinic. This information is expected to assist the clinician in the treatment choice for a
      particular patient and guide future clinical research.
    

Intervention name(s): High Frequency TENS; Low frequency TENS; Placebo TENS
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes; 100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes; 100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds
Other intervention name(s): Electrical stimulation; Electrical stimulation; Placebo electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee OA; TENS