Unilateral Primary Osteoarthritis of Knee, Primary Osteoarthritis of Knee Nos
Conditions
Keywords
Knee OA, TENS, Total knee replacement, Knee arthroplasty, total unilateral knee replacement
Brief 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.
Interventions
DEVICEPlacebo 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.
DEVICEActive 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).
Sponsors
Barbara A Rakel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Pain With Movement | 1 day post-op | 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). |
| Self-reported Pain With Walking (From Iowa Gait Test) | 2 days post-op | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intense 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).
Intense TENS (EMPI Select 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). | 122 |
| 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. | 123 |
| Standard Care Subjects randomized to Standard Care will be given no TENS unit. | 72 |
| Total | 317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 6 | 4 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 24 | 10 |
Baseline characteristics
| Characteristic | Total | Standard Care | Placebo TENS | Intense TENS |
|---|---|---|---|---|
| Age, Continuous | 62.3 Years | 62.2 Years | 61.9 Years | 62.7 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 310 Participants | 71 Participants | 121 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Gait Speed Test | 61.9 feet in 15 seconds | 60.5 feet in 15 seconds | 62.7 feet in 15 seconds | 61.9 feet in 15 seconds |
| Heat Pain Threshold | 43.4 Degrees Celsius | 43.6 Degrees Celsius | 43.3 Degrees Celsius | 43.3 Degrees Celsius |
| Heat Pain Tolerance | 47.1 Degrees Celsius | 47.1 Degrees Celsius | 46.8 Degrees Celsius | 47.4 Degrees Celsius |
| Knee Range of Motion: Extension | -5.3 Degrees | -6.5 Degrees | -4.8 Degrees | -5 Degrees |
| Pain at rest | 3.28 scores on a scale | 3.76 scores on a scale | 3.35 scores on a scale | 2.92 scores on a scale |
| Pain with knee range of motion: Extension | 7.13 scores on a scale | 8.03 scores on a scale | 7.03 scores on a scale | 6.69 scores on a scale |
| Pain with walking | 6.52 scores on a scale | 7.65 scores on a scale | 6.29 scores on a scale | 6.1 scores on a scale |
| Pressure Pain Threshold | 255.16 kilopascal (kPa) | 247 kilopascal (kPa) | 251.02 kilopascal (kPa) | 264.08 kilopascal (kPa) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 3 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 299 Participants | 68 Participants | 117 Participants | 114 Participants |
| Range of motion: Flextion | 113 Degrees | 109.8 Degrees | 115.4 Degrees | 112.5 Degrees |
| Sex: Female, Male Female | 172 Participants | 42 Participants | 65 Participants | 65 Participants |
| Sex: Female, Male Male | 145 Participants | 30 Participants | 58 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 123 | 0 / 72 |
| other Total, other adverse events | 4 / 122 | 7 / 123 | 2 / 72 |
| serious Total, serious adverse events | 7 / 122 | 3 / 123 | 6 / 72 |
Outcome results
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).
Time frame: 1 day post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intense TENS | Self-Reported Pain With Movement | 9.5 scores on a scale |
| Placebo TENS | Self-Reported Pain With Movement | 10 scores on a scale |
| Standard Care | Self-Reported Pain With Movement | 14 scores on a scale |
Comparison: There were instances of missing data due to patient time restraints and patient refusal.p-value: 0.016Kruskal-Wallis
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).
Time frame: 2 days post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intense TENS | Self-reported Pain With Walking (From Iowa Gait Test) | 8 scores on a scale |
| Placebo TENS | Self-reported Pain With Walking (From Iowa Gait Test) | 10 scores on a scale |
| Standard Care | Self-reported Pain With Walking (From Iowa Gait Test) | 10 scores on a scale |
Comparison: There were instances of missing data due to patient time restraints and patient refusal.p-value: 0.008Kruskal-Wallis