Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
6 juli 2012 uppdaterad av: Amp Orthopedics, Inc.
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial
The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF), a type of electromagnetic field treatment with the Ivivi Torino II for reducing post-operative narcotic use in patients recovering from Total Knee Arthroplasty.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.
The purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.
Studietyp
Interventionell
Inskrivning (Faktisk)
23
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Virginia
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Alexandria, Virginia, Förenta staterna, 22306
- Anderson Orthopaedic Research Institute
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 40 to 80 years
- Primary diagnosis of knee OA
- Appropriate candidate for TKA
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study product and methods including follow-up
Exclusion Criteria:
- Body mass index > 40 kg/m2
- Scheduled for bilateral TKA
- Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
- Use of narcotic pain medication for any condition in the last 1 month prior to surgery
- Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
- Pregnant or lactating female
- Participation in any clinical trial in the past 30 days
- Vulnerable populations including prisoners and nursing home residents
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Sham Comparator: Bluff
|
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Andra namn:
Sham treatment for 4 weeks post-surgery
Andra namn:
|
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Aktiv komparator: Targeted pulsed electromagnetic field
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Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Andra namn:
Sham treatment for 4 weeks post-surgery
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
Tidsram: 2-week follow-up period from surgery
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2-week follow-up period from surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
Tidsram: 1 and 4 weeks post-surgery
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1 and 4 weeks post-surgery
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Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
Tidsram: At intervals over the 4-week follow-up period
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Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation
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At intervals over the 4-week follow-up period
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The measurement of knee joint circumference
Tidsram: Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients
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Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
|
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Range of motion of the knee joint, assessed using the knee flexion technique
Tidsram: Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
|
Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.
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Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
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OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
Tidsram: 4 weeks post-surgery
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Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
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4 weeks post-surgery
|
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Adverse Events collected and analyzed for confirmation of device safety
Tidsram: Randomization to 4 weeks post-surgery
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Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs).
Adverse events will be recorded daily.
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Randomization to 4 weeks post-surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Gerard A. Engh, M.D., Anderson Orthopaedic Research Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2011
Primärt slutförande (Faktisk)
1 juli 2012
Avslutad studie (Faktisk)
1 juli 2012
Studieregistreringsdatum
Först inskickad
17 november 2011
Först inskickad som uppfyllde QC-kriterierna
17 november 2011
Första postat (Uppskatta)
21 november 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 juli 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2012
Senast verifierad
1 juli 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IOH-TKA-001
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