Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
6. april 2021 opdateret af: Orthopaedic Research Foundation
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis.
Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace.
Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
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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Indiana
-
Greenwood, Indiana, Forenede Stater, 46143
- OrthoIndy
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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
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject is being treated for knee joint pain
- Subject is willing and able to comply with the evaluation schedule
Exclusion Criteria:
- Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
- Subject has current alcohol, opioid, or other drug dependence
- Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
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 |
|---|---|
|
Aktiv komparator: Exercise Only
Home exercise program.
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This group will be given a set of 2 exercises to complete at home.
The exercises are designed to strengthen the quadriceps muscle group.
|
|
Aktiv komparator: Brace Only
Reaction Web brace.
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This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
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Aktiv komparator: Bracing + Exercises
Reaction Web brace and home exercises.
|
This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of Pain Using the Visual Analog Scale
Tidsramme: Baseline and 3-month Visit
|
The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends.
Participants will be asked to mark on the line where their pain is in relation to the two extremes.
Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100.
The difference between the baseline score and score at the 3-month study visit was compared between study arms.
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Baseline and 3-month Visit
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quadriceps Force
Tidsramme: Baseline and 3-month Visit
|
Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline.
Averages are stratified by study arm.
Negative values indicate a reduction in quadriceps force from baseline to 3-month.
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Baseline and 3-month Visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Frank R Kolisek, MD, study principal investigator
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. marts 2015
Primær færdiggørelse (Faktiske)
31. december 2016
Studieafslutning (Faktiske)
31. december 2016
Datoer for studieregistrering
Først indsendt
4. marts 2015
Først indsendt, der opfyldte QC-kriterier
9. marts 2015
Først opslået (Skøn)
17. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FRKDJO-RWB-15
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared, only averages and summaries where all participant data is combined.
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 .