Knee OsteoarthritisTOPSNCT01354054
TENS Effectiveness and Knee Osteoarthritis in Humans
A study testing High Frequency TENS and Low frequency TENS in people with Knee Osteoarthritis, run by University of Iowa at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High Frequency TENS and Low frequency TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Department of Physical Therapy Federal university of Sergipe
Aracaju
United Kingdom1 site
Health and Rehabilitation Science Research Institute, University of Ulster , UK
Newtownabbey, Northern Ireland
About this study
Official title: Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- High Frequency TENS, Low frequency TENS, Placebo TENS
- Keywords
- Knee OA, TENS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency TENSProcedure or surgery
Also called Electrical stimulation
100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes
Low frequency TENSProcedure or surgery
Also called Electrical stimulation
100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes
Placebo TENSProcedure or surgery
Also called Placebo electrical stimulation
100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| High frrequency TENS | Experimental | 100 Hz TENS, 100 usec Receives: Procedure: High Frequency TENS |
| Low frequency TENS | Experimental | 4 Hz, 100 usec TENS Receives: Procedure: Low frequency TENS |
| Placebo TENS | Experimental | 100 Hz, 100 usec, set at motor minus 10% then ramps to off in 45 sec, 40 minutes Receives: Procedure: Placebo TENS |
| Control | No intervention | Age matched controls, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- Barbarb A Rakel, PhD, Principal investigator, University of Iowa College of NursingKathleen A Sluka, PhD, Principal investigator, University of Iowa Physical Therapy and Rehabilitation Science Graduate Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354054
- Sponsor's protocol ID
- TENS/tops/sluka/rakel
- Acronym
- TOPS
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14622708Vance 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.
PubMed 22466027
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01354054
- Acronym / sponsor ID
- TOPS / TENS/tops/sluka/rakel
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee OA, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High frrequency TENS | Experimental | Procedure: High Frequency TENS100 Hz TENS, 100 usec |
| Low frequency TENS | Experimental | Procedure: Low frequency TENS4 Hz, 100 usec TENS |
| Placebo TENS | Experimental | Procedure: Placebo TENS100 Hz, 100 usec, set at motor minus 10% then ramps to off in 45 sec, 40 minutes |
| Control | No intervention | –Age matched controls, no intervention |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency TENSAlso: Electrical stimulation100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes | Procedure or surgery | High frrequency TENS |
| Low frequency TENSAlso: Electrical stimulation100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes | Procedure or surgery | Low frequency TENS |
| Placebo TENSAlso: Placebo electrical stimulation100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds | Procedure or surgery | Placebo TENS |
Primary outcome
Pressure pain threshold
Time frame: 3 hours
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.
Timed Up and Go test
Time frame: 3 hours
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.
Pain Intensity measures
Time frame: 3 hours
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.
Thermal Pain threshold (HPT) and Temporal summation (HTS)
Time frame: 3 hours
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.
Cutaneous Mechanical Pain testing
Time frame: 3 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
- Background: PubMed 14622708Sluka 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.
- Derived from this study: PubMed 22466027Vance 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbarb A Rakel, PhD principal investigator
University of Iowa College of Nursing
Kathleen A Sluka, PhD principal investigator
University of Iowa Physical Therapy and Rehabilitation Science Graduate Program
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency TENS and Low frequency TENS in people with Knee Osteoarthritis, run by University of Iowa at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Brazil, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: 3 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.