title: Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial.
abstract: Wedged insoles are believed to be of clinical benefit to individuals with knee osteoarthritis by reducing the knee adduction moment (KAM) during gait. However, previous clinical trials have not specifically controlled for KAM reduction at baseline, thus it is unknown if reduced KAMs actually confer a clinical benefit. Forty-eight participants with medial knee osteoarthritis were randomly assigned to either a control group where no footwear intervention was given, or a wedged insole group where KAM reduction was confirmed at baseline. KAMs, Knee Injury and Osteoarthritis Outcome Score (KOOS) and Physical Activity Scale for the Elderly (PASE) scores were measured at baseline. KOOS and PASE surveys were re-administered at three months follow-up. The wedged insole group did not experience a statistically significant or clinically meaningful change in KOOS pain over three months (p=0.173). Furthermore, there was no association between change in KAM magnitude and change in KOOS pain over three months within the wedged insole group (R2=0.02, p=0.595). Improvement in KOOS pain for the wedged insole group was associated with worse baseline pain, and a change in PASE score over the three month study (R2=0.57, p=0.007). As an exploratory comparison, there was no significant difference in change in KOOS pain (p=0.49) between the insole and control group over three months. These results suggest that reduced KAMs do not appear to provide any clinical benefit compared to no intervention over a follow-up period of three months. ClinicalTrials.gov ID Number: NCT02067208.
authors: Schulich School of Engineering, University of Calgary, Calgary, Alberta, Canada; Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada. Electronic address: lewinson@ucalgary.ca.
authors: Ryan T
authors: RT
authors: Lewinson
authors: Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors: Isabelle A
authors: IA
authors: Vallerand
authors: Schulich School of Engineering, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: Kelsey H
authors: KH
authors: Collins
authors: Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: J Preston
authors: JP
authors: Wiley
authors: Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: Victor M Y
authors: VMY
authors: Lun
authors: Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors: Chirag
authors: C
authors: Patel
authors: Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.
authors: Linda J
authors: LJ
authors: Woodhouse
authors: Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: Raylene A
authors: RA
authors: Reimer
authors: Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada; Nike Sport Research Laboratory, Nike Inc., Beaverton, OR, USA.
authors: Jay T
authors: JT
authors: Worobets
authors: Schulich School of Engineering, University of Calgary, Calgary, Alberta, Canada; Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: Walter
authors: W
authors: Herzog
authors: Schulich School of Engineering, University of Calgary, Calgary, Alberta, Canada; Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
authors: Darren J
authors: DJ
authors: Stefanyshyn
mesh_terms: D000368:Aged; D018771:Arthralgia / Q000209:etiology / Q000534:rehabilitation*; D001696:Biomechanical Phenomena; D015444:Exercise; D005260:Female; D061826:Foot Orthoses; D005684:Gait; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D020370:Osteoarthritis, Knee / Q000150:complications / Q000503:physiopathology / Q000534:rehabilitation*; D010146:Pain; D012775:Shoes; D016037:Single-Blind Method
keywords: Biomechanics; Clinical trial; Footwear; Gait; Loading; Wedged insole