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Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)

Primary Purpose

Osteoarthritis, Knee, Arthritis, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMPI Select TENS
Placebo EMPI Select TENS
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total Knee Arthroplasty (TKA), Transcutaneous Electrical Nerve Stimulation (TENS), Pain, Function, Knee Osteoarthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing unilateral primary total knee arthroplasty
  • Patients who are between the ages of 18-85 years
  • Patient has signed informed consent

Exclusion Criteria:

  • Patients who live >100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195)
  • Patients who will not receive a femoral nerve catheter for surgery
  • Patients who are not planned to be discharged directly home following surgery
  • Patients who have used a TENS device in the past
  • Preoperative daily use of narcotics (i.e., high tolerance)
  • Already enrolled in another research study, including the present study for contralateral knee
  • Patients with a history of epilepsy
  • Patients with a cardiac pacemaker
  • Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device
  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active TENS

Placebo TENS

Arm Description

Active TENS (EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.

Placebo TENS (Placebo EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.

Outcomes

Primary Outcome Measures

Narcotic Usage
Morphine Equivalent dose, mg/kg

Secondary Outcome Measures

Visual Analog Pain Score (VAS)
Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
Functional Assessments
Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
General Health Outcome - SF-12 Physical Component Summary
Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.

Full Information

First Posted
June 19, 2012
Last Updated
March 2, 2018
Sponsor
The Cleveland Clinic
Collaborators
DJO Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01641471
Brief Title
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)
Official Title
Prospective Evaluation of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief Following Total Knee Arthroplasty (TKA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
DJO Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
Detailed Description
A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an active TENS unit and the other 58 patients will be randomly selected to be treated with the placebo TENS unit (control group). Patients will be enrolled at two sites within the Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and control groups will receive a femoral nerve catheter, standard during a primary TKA. It is hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic usage, reduce pain, and allow for a quicker return to function following TKA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Arthritis, Pain
Keywords
Total Knee Arthroplasty (TKA), Transcutaneous Electrical Nerve Stimulation (TENS), Pain, Function, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Experimental
Arm Description
Active TENS (EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
Arm Title
Placebo TENS
Arm Type
Placebo Comparator
Arm Description
Placebo TENS (Placebo EMPI Select TENS) in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Intervention Type
Device
Intervention Name(s)
EMPI Select TENS
Intervention Description
The unit is capable of 0-60 milliamps of output current.
Intervention Type
Device
Intervention Name(s)
Placebo EMPI Select TENS
Intervention Description
The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.
Primary Outcome Measure Information:
Title
Narcotic Usage
Description
Morphine Equivalent dose, mg/kg
Time Frame
Through 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Visual Analog Pain Score (VAS)
Description
Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
Time Frame
6 weeks (+/- 3 days) postoperative
Title
Functional Assessments
Description
Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Time Frame
6 weeks (+/- 3 days) postoperative
Title
General Health Outcome - SF-12 Physical Component Summary
Description
Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.
Time Frame
6 weeks (+/- 3 days) postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing unilateral primary total knee arthroplasty Patients who are between the ages of 18-85 years Patient has signed informed consent Exclusion Criteria: Patients who live >100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195) Patients who will not receive a femoral nerve catheter for surgery Patients who are not planned to be discharged directly home following surgery Patients who have used a TENS device in the past Preoperative daily use of narcotics (i.e., high tolerance) Already enrolled in another research study, including the present study for contralateral knee Patients with a history of epilepsy Patients with a cardiac pacemaker Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael K Barsoum, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6332127
Citation
Cornell PE, Lopez AL, Malofsky H. Pain reduction with transcutaneous electrical nerve stimulation after foot surgery. J Foot Surg. 1984 Jul-Aug;23(4):326-33.
Results Reference
background
PubMed Identifier
3490659
Citation
Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06.
Results Reference
background
PubMed Identifier
12600800
Citation
Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
Results Reference
background
PubMed Identifier
14716650
Citation
Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.
Results Reference
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Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)

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