- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02320500
Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks.
The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.
The Secondary outcomes will include:
(Comparisons between and/or within groups where appropriate):
- Pain score biweekly up to 8 weeks, at 3 months and 6 months
- Decision to proceed with surgery (yes/no)-to assess the alteration in the need for TKA
- Decision to continue treatment-(yes/no) is treatment beneficial?
- Function -Biodex, 6 min.walk test, Timed up and go- Measured at baseline and 3 months following last therapy session for standard vs. myofascial -is myofascial therapy better for function?
- Brief Pain Interference (BPI) short form- Baseline, 2 weeks and 8 weeks- to assess pain interference
- Oxford knee scores-Baseline, 2 and 8 weeks- reported functional disability (compare groups and to objective measures)
- McGill SF pain questionnaire at Baseline, 2 weeks and 8 weeks-to assess pain quality
- SF-12 at Baseline, 2 weeks and 8 weeks-to assess quality of life
- Analgesics consumed at Baseline, 2 weeks, 8 weeks, 6 months-to assess pain levels
- Compare the X-ray osteoarthritis (OA) grade with initial assessment of MTPs-Does presence of myofascial trigger points (MTPs) explain discordance between OA grade and pain?
- Pain scores on a 10 cm visual analogue scale at Baseline, 2 weeks, 6 months- assess change in pain intensity
- Surgery by 6 month follow-up? Yes/No, If so, when? - postponed or eliminated need for TKA?
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Kingston, Ontario, Canada
- Hôtel Dieu Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- diagnosis of bi or unilateral knee OA
- knee pain attributed to knee OA
- referral to orthopedics as a potential candidate for knee total knee arthroplasty
- ability to comprehend/sign consent, independent mobility without assistive devices
Exclusion Criteria:
- allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
- infections of clinical abnormalities other than knee OA that could cause the knee pain
- other diagnosed chronic pain syndrome for which they are taking regular pain medications
- pregnancy or breast-feeding
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: standard physiotherapy
Standard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA)
|
standard of care physiotherapy once every 2 weeks for 8 weeks
|
Experimenteel: Myofascial-specific therapy
Patient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks)
|
Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Pain scores on visual analogue scale (VAS)
Tijdsspanne: 8 weeks
|
8 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Brief pain inventory (BPI)
Tijdsspanne: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
Oxford knee score
Tijdsspanne: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
McGill short pain questionnaire
Tijdsspanne: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
timed up and go (TUG)
Tijdsspanne: Baseline, 3 months
|
Baseline, 3 months
|
6 minute walk test
Tijdsspanne: Baseline, 3 months
|
Baseline, 3 months
|
Biodex functional tests
Tijdsspanne: Baseline, 3 months
|
Baseline, 3 months
|
total knee arthroplasty? If so, when
Tijdsspanne: 6 month
|
6 month
|
VAS pain scores
Tijdsspanne: biweekly up to 8 weeks, then 3 months & 6 months
|
biweekly up to 8 weeks, then 3 months & 6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Richard Henry, MD, FRCPC, Queens University/Kingston General Hospital
- Hoofdonderzoeker: Gavin Wood, MD, FRCSC, Queens University/Kingston General Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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
- ANAE-217-12
- NOL 158909 (Andere identificatie: Health Canada)
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 Artrose, knie
-
ACE Running LLCAir ForceNog niet aan het werven
-
Smith & Nephew, Inc.VoltooidJourney II BCS Total Knee-systeemVerenigde Staten, België, Nieuw-Zeeland
-
Université Catholique de LouvainActief, niet wervend
-
Smith & Nephew, Inc.Nor Consult, LLCVoltooidJourney II XR Total Knee-systeemVerenigde Staten
-
Smith & Nephew, Inc.Nor ConsultVoltooidJourney II CR Total Knee-systeemVerenigde Staten
-
Cartiva, Inc.BeëindigdOSTEOARTHRITISVerenigde Staten
-
Federal University of Rio Grande do SulVoltooid
-
Jiangsu XinChen-Techfields Pharma Co., LTD.VoltooidKNIE OSTEOARTHRITISChina
-
Riphah International UniversityVoltooidRunner's KneePakistan
-
Federal University of São PauloVoltooidKNIE OSTEOARTHRITISBrazilië
Klinische onderzoeken op Standard Physiotherapy
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR)Actief, niet wervend
-
Sunnybrook Health Sciences CentreActief, niet wervendRotator cuff pathologieCanada
-
Compedica IncProfessional Education and Research InstituteWervingDiabetische voetzweerVerenigde Staten, Canada
-
NYU Langone HealthVoltooidMultiple scleroseVerenigde Staten
-
Brian W. NoehrenU.S. Army Medical Research and Development CommandWervingFemorale breuk | Tibiale fracturenVerenigde Staten
-
Medical University of South CarolinaIcahn School of Medicine at Mount SinaiVoltooidIschemische cerebrovasculair accidentVerenigde Staten
-
OrganogenesisVoltooidVeneuze zweerVerenigde Staten
-
Coloplast A/SBeëindigdHuid conditie | LekkageDenemarken, Frankrijk, Duitsland, IJsland
-
Nohla Therapeutics, Inc.BeëindigdLeukemie, myeloïde, acuutVerenigde Staten, Korea, republiek van, Australië
-
Hospital Universitario Ramon y CajalOnbekendCardiogene shockSpanje