TENS Effectiveness and Knee Osteoarthritis in Humans
TOPS
Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis
1 other identifier
interventional
100
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Nov 2006
Typical duration for not_applicable knee-osteoarthritis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedMay 16, 2011
May 1, 2011
2.6 years
May 9, 2011
May 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Pressure pain threshold
A handheld digital pressure algometer (Somedic AB, Farsta, Sweden), was used to assess PPT with the 1 cm2 circular probe. Pressure was applied at 40 kPa/s and patients were instructed to press the hand held response switch when the sensation first became painful. Familiarization with the proceedure was accomplished with testing on the non-dominant forearm of each subject. Following this familiarization procedure, PPTs were assessed at the knee and anterior tibialis muscle bilaterally. An average of the three trials at each test site was used for analysis.
3 hours
Timed Up and Go test
The TUG is a standardized test where on command subjects arise from a chair with no arm rest, ambulate 9.8 feet as quickly and safely as possible, turn, ambulate back, turn and return to sitting in the chair. The walking distance was measured in advance and marked on the floor with tape marks well visualized by subjects. Subjects were timed in a standardized fashion from the moment the upper back left the chair until return to full sitting position with back in contact with the chair.
3 hours
Pain Intensity measures
Subjects were asked to rate their pain intensity on a horizontal 100 mm Visual Analog Scale (VAS). The anchors utilized were "no pain" and "worst imaginable pain". VAS measures were taken at rest, during the TUG, during the HTS, and cutaneous mechanical pain testing.
3 hours
Thermal Pain threshold (HPT) and Temporal summation (HTS)
The TSA II NeuroSensory Analyzer was used to assess (HPT)and (HTS). For both measures, the 5 cm2 probe was placed and initial temperature was set at 37oC, and increased at 1 °C/s to a maximum of 52 oC. Subjects indicated when they first felt pain by using the remote patient switch which recorded the temperature . For temporal summation (HTS), a tonic heat stimulus of 45.5 oC was applied for 20 s. After building to the 45.5 oC in the first 5 s, subjects rated pain caused by this stimulus on a 10 cm visual analog scale every 5s for 15s.
3 hours
Cutaneous Mechanical Pain testing
Cutaneous mechanical pain thresholds were assessed with a series of von Frey filaments (North Coast Medical, Gilroy, CA) applied in ascending order from 0.008 to 300 g (0.008, 0.02, 0.04, 0.07, 0.16, 0.4, 0.6, 1.0, 1.4, 2, 4, 6, 8, 10, 15, 26, 60, 100, 180, 300 g). In addition, the subjects rated their pain on a 100 mm VAS in response to application of a 6 g von Frey filament at the six sites bilaterally.
3 hours
Study Arms (4)
High frrequency TENS
EXPERIMENTAL100 Hz TENS, 100 usec
Low frequency TENS
EXPERIMENTAL4 Hz, 100 usec TENS
Placebo TENS
EXPERIMENTAL100 Hz, 100 usec, set at motor minus 10% then ramps to off in 45 sec, 40 minutes
Control
NO INTERVENTIONAge matched controls, no intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- diagnosis of medial compartment knee osteoarthritis
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Iowa
Iowa City, Iowa, 52242, 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
Related Publications (2)
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.
PMID: 14622708BACKGROUNDVance 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.
PMID: 22466027DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbarb A Rakel, PhD
University of Iowa College of Nursing
- PRINCIPAL INVESTIGATOR
Kathleen A Sluka, PhD
University of Iowa Physical Therapy and Rehabilitation Science Graduate Program
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 16, 2011
Study Start
November 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 16, 2011
Record last verified: 2011-05