Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2006-11-30
2009-06-30
Brief Summary
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Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with movement resulting in increased function.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High frrequency TENS
100 Hz TENS, 100 usec
High Frequency TENS
100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes
Low frequency TENS
4 Hz, 100 usec TENS
Low frequency TENS
100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes
Placebo TENS
100 Hz, 100 usec, set at motor minus 10% then ramps to off in 45 sec, 40 minutes
Placebo TENS
100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds
Control
Age matched controls, no intervention
No interventions assigned to this group
Interventions
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High Frequency TENS
100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes
Low frequency TENS
100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes
Placebo TENS
100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 injection in the last four weeks
* serious medical condition, uncontrolled diabetes mellitus, hypertension
* dementia or cognitive impairment
* permanent lower extremity sensory
* prior TENS use
30 Years
95 Years
ALL
Yes
Sponsors
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University of Iowa
OTHER
Responsible Party
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University of Iowa
Principal Investigators
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Barbarb A Rakel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa College of Nursing
Kathleen A Sluka, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Physical Therapy and Rehabilitation Science Graduate Program
Locations
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University of Iowa
Iowa City, Iowa, United States
Department of Physical Therapy Federal university of Sergipe
Aracaju, , Brazil
Health and Rehabilitation Science Research Institute, University of Ulster , UK
Newtownabbey, Northern Ireland, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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TENS/tops/sluka/rakel
Identifier Type: -
Identifier Source: org_study_id
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