Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TENS Effectiveness and Knee Osteoarthritis in Humans (TOPS)

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01354054
First received: May 9, 2011
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Procedure: High Frequency TENS
Procedure: Low frequency TENS
Procedure: Placebo TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Pressure pain threshold [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: November 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High frrequency TENS
100 Hz TENS, 100 usec
Procedure: High Frequency TENS
100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes
Other Name: Electrical stimulation
Experimental: Low frequency TENS
4 Hz, 100 usec TENS
Procedure: Low frequency TENS
100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes
Other Name: Electrical stimulation
Experimental: Placebo TENS
100 Hz, 100 usec, set at motor minus 10% then ramps to off in 45 sec, 40 minutes
Procedure: 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 Name: Placebo electrical stimulation
No Intervention: Control
Age matched controls, no intervention

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

Ages Eligible for Study:   30 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354054

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Brazil
Department of Physical Therapy Federal university of Sergipe
Aracaju, Brazil
United Kingdom
Health and Rehabilitation Science Research Institute, University of Ulster , UK
Newtownabbey, Northern Ireland, United Kingdom
Sponsors and Collaborators
University of Iowa
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Rakel, PhD, University of Iowa
ClinicalTrials.gov Identifier: NCT01354054     History of Changes
Other Study ID Numbers: TENS/tops/sluka/rakel
Study First Received: May 9, 2011
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Knee OA
TENS

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014