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Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The device does not produce heat or any sensation. There are two basic requirements to use the device, switching it on via an on/off switch, and affixing the device over the target area of the body. The area of treatment is confined to the area within the 11.5-cm diameter loop antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be shaped to fit the area/location being treated as required. The device can be used up to 24 h per day and is placed over the area of localized pain either using medical tape or a specifically designed wrap.
In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with placebo. Additionally, pain tolerance and physical health improved in PainGear -treated patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic therapy. No adverse events were detected.
Studietype
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Chronic musculoskeletal pain of more than 6 month duration
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Male or female ages 18-80 years old
- A current VAS pain rating ≥5/10
- Able to complete and tolerate treatment for the study period.
Exclusion Criteria:
- Pregnant Woman
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
- Patients using personal home based electrical stimulation devices
- Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
- Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).
- Scheduled elective surgery or other procedures requiring general anesthesia during the trial.
- Participant with life expectancy of less than 6 months, or inappropriate for placebo medication.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who are not able to understand verbal or written English, and for whom adequate translation/interpretation cannot be readily obtained
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To assess difference in subjective pain with the use of PainGear for 2 weeks.
Tijdsspanne: 2 weeks
|
[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]
|
2 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To record change in frequency of other analgesic modalities utilization
Tijdsspanne: 2 weeks period
|
[ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]
|
2 weeks period
|
To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Tijdsspanne: 2 weeks, recorded on 1st and 14th day
|
[ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]
|
2 weeks, recorded on 1st and 14th day
|
To assess patients satisfaction with two weeks therapy of PainGear
Tijdsspanne: 14th day
|
[Time Frame: 14th day]
|
14th day
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PE/PAINGEAR/09/2016
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Pain Gear
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Cameroon Baptist Convention HealthCarolinas Medical CenterVoltooid
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University of Texas Southwestern Medical CenterGus Gear IncWerving
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University of California, San FranciscoWervingPijn, procedureel | Sedatie Complicatie | Procedurele angstVerenigde Staten
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Kathleen FrielOnbekendNeuropatische pijn | RuggenmergletselsVerenigde Staten
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Children's Hospital Los AngelesAppliedVR Inc.WervingPijn | Allergie | Ongerustheid | Virtuele realiteit | Gastro-enterologie | Radiologie | Bloedafname | OrthopedieVerenigde Staten
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Stuart WongActief, niet wervendOrale mucositisVerenigde Staten
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Teesside UniversityConnect Health LtdVoltooid
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University Hospital MuensterPalliativnetz Muenster gGmbHOnbekendPijn | Palliatieve zorg | Virtuele realiteitDuitsland
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Pfizer's Upjohn has merged with Mylan to form Viatris...VoltooidNeuralgie | Neuropatische pijn | Zenuwpijn
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University of FloridaAgency for Healthcare Research and Quality (AHRQ)Nog niet aan het wervenMusculoskeletale pijn | Chronische pijn | Opioïde gebruik