TENS Effectiveness and Knee Osteoarthritis in Humans

Knee Osteoarthritis Clinical Trial

— TOPS  

Official title:

Effects of a Single Treatment of High or Low Frequency TENS on Pain, Hyperalgesia and Function in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354054
• Other study ID #: TENS/tops/sluka/rakel
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 12, 2011
• Start date: November 2006
• Est. completion date: June 2009

Study information

• Verified date: May 2011
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy Federal university of Sergipe	Aracaju
United Kingdom	Health and Rehabilitation Science Research Institute, University of Ulster , UK	Newtownabbey	Northern Ireland
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Countries where clinical trial is conducted

United States,  Brazil,  United Kingdom, 

References & Publications (1)

Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No