Clinical trial NCT01354054: TENS Effectiveness and Knee Osteoarthritis in Humans
Official title: Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee OA
TENS
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of medial compartment knee osteoarthritis
* 18 and 60 years of age
* being able to ambulate to the mail box and back
* stable medication schedule over the last three weeks
* pain rating \> 3 on a 0-10 scale when verbally asked to rate knee pain in the weight bearing position
* normal L1-S2 dermatomal screen and normal great toe and thumb proprioception.

Exclusion Criteria:

* Knee surgery in the last six months
* Knee injection in the last four weeks
* serious medical condition, uncontrolled diabetes mellitus, hypertension
* dementia or cognitive impairment
* permanent lower extremity sensory
* prior TENS use

Primary outcomes:
measure: Pressure pain threshold
timeFrame: 3 hours
measure: Timed Up and Go test
timeFrame: 3 hours
measure: Pain Intensity measures
timeFrame: 3 hours
measure: Thermal Pain threshold (HPT) and Temporal summation (HTS)
timeFrame: 3 hours
measure: Cutaneous Mechanical Pain testing
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Aracaju
country: Brazil
facility: Department of Physical Therapy Federal university of Sergipe
city: Newtownabbey
country: United Kingdom
facility: Health and Rehabilitation Science Research Institute, University of Ulster , UK
state: Northern Ireland
Study officials:
affiliation: University of Iowa College of Nursing
name: Barbarb A Rakel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Physical Therapy and Rehabilitation Science Graduate Program
name: Kathleen A Sluka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
citation: Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.