- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00865046
Periosteal Stimulation for Knee Osteoarthritis (PST)
22. januar 2015 opdateret af: US Department of Veterans Affairs
Efficacy of Periosteal Stimulation and Boosters for Advanced Knee OA Pain
185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST).
Participants will be divided into three groups.
They will receive PST or a control condition once a week for 10 weeks.
Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months.
Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain.
The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST.
Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST.
In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months.
Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy).
Monthly telephone calls will assess pain, interim illness and physical activity.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
190
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15206
- Geriatric Research, Education, and Clinical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 89 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- English speaking,
- Knee pain on most days of the past 3 months that is more severe than pain in other parts of the lower body,
- Advanced knee OA by x-ray,
- age 50-89
Exclusion Criteria:
- Non-ambulatory or severely impaired mobility (i.e., require the use of a walker),
- Folstein MMSE < 24,
- Severe uncorrected visual or hearing impairment,
- Knee pain due to factors other than OA,
- Large knee effusion,
- History of corticosteroid or hyaluronic acid injection in the affected knee(s) during the preceding 3 months,
- Acute or terminal illness,
- Immune suppression,
- Anticoagulation therapy,
- Pacemaker,
- Prior PST treatment
- Active participation in other studies currently
- Age >89
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PST + PST boosters
PST once a week for 10 weeks, then tapering over 6 months
|
Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue.
All needles are stimulated with 100 Hz current.
The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Aktiv komparator: PST + control-PST boosters
PST once a week for 10 weeks, then control-PST tapering over 6 months
|
Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue.
All needles are stimulated with 100 Hz current.
The stimulation of the needles in the soft tissue is discontinued after one minute.
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Placebo komparator: Control-PST
control-PST for 10 weeks
|
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain (WOMAC)
Tidsramme: 9 months following baseline
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome) |
9 months following baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Debra K. Weiner, MD, Geriatric Research, Education, and Clinical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. september 2013
Datoer for studieregistrering
Først indsendt
17. marts 2009
Først indsendt, der opfyldte QC-kriterier
18. marts 2009
Først opslået (Skøn)
19. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A6614-R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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