Effect of TENS for Pain and Function After Total Knee Replacement

Primary Osteoarthritis of Knee Nos Clinical Trial

— TANK  

Official title:

Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364870
• Other study ID #: 200706725
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: October 24, 2017
• Start date: May 2008
• Est. completion date: May 2012

Study information

• Verified date: October 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia. Minimizing the severe pain experienced during required activities in the immediate postoperative period will promote functional recovery and prevent the development of new chronic pain syndromes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

Inclusion Criteria:

• Primary osteoarthritis of the knee

• Speak English

• Unilateral total knee replacement

Exclusion Criteria:

• No ambulation, assisted or otherwise

• Use of TENS by subject in past 5 yrs

• Current use of TENS by someone else in subject's household

• Stroke or other condition which seriously impairs sensation in legs or ability to follow directions.

• Condition that precludes use of TENS (pacemaker, allergy to nickel, etc.)

• Chronic pain (other than in surgical knee) that is currently being treated or is severe. (Do not exclude for fibromyalgia).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos
• Unilateral Primary Osteoarthritis of Knee

Intervention

Device:
• Placebo TENS
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
• Active TENS
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (µs).

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Barbara A Rakel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Pain With Movement	While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").	1 day post-op
Primary	Self-reported Pain With Walking (From Iowa Gait Test)	Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").	2 days post-op