Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To assess difference in subjective pain with the use of PainGear for 2 weeks.
Lasso di tempo: 2 weeks
|
[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]
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2 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To record change in frequency of other analgesic modalities utilization
Lasso di tempo: 2 weeks period
|
[ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]
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2 weeks period
|
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To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Lasso di tempo: 2 weeks, recorded on 1st and 14th day
|
[ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]
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2 weeks, recorded on 1st and 14th day
|
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To assess patients satisfaction with two weeks therapy of PainGear
Lasso di tempo: 14th day
|
[Time Frame: 14th day]
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14th day
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Collaboratori e investigatori
Sponsor
Collaboratori
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PE/PAINGEAR/09/2016
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .