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    The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial. Holsgaard-Larsen A,Clausen B,Søndergaard J,Christensen R,Andriacchi T P,Roos E M Osteoarthritis and cartilage OBJECTIVE:To investigate the effect of a neuro-muscular exercise (NEMEX) therapy program compared with instructions in optimized analgesics and anti-inflammatory drug use (PHARMA), on measures of knee-joint load in people with mild to moderate knee osteoarthritis (OA). We hypothesized that knee joint loading during walking would be reduced by NEMEX and potentially increased by PHARMA. DESIGN:Single-blind, randomized controlled trial (RCT) comparing NEMEX therapy twice a week with PHARMA. Participants with mild-to-moderate medial tibiofemoral knee OA were randomly allocated (1:1) to one of two 8-week treatments. Primary outcome was change in knee load during walking (Knee Index, a composite score from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes were frontal plane peak knee adduction moment (KAM), Knee Injury and Osteoarthritis Outcome Scores (KOOS) and functional performance tests. RESULTS:Ninety three participants (57% women, 58 ± 8 years with a body mass index [BMI] of 27 ± 4 kg/m (mean ± standard deviation [SD])) were randomized to NEMEX group (n = 47) or PHARMA (n = 46); data from 44 (94%) and 41 (89%) participants respectively, were available at follow-up. 49% of the participants in NEMEX and only 7% in PHARMA demonstrated good compliance. We found no difference in the primary outcome as evaluated by the Knee Index -0.07 [-0.17; 0.04] Nm/%BW HT. Secondary outcomes largely supported this finding. CONCLUSIONS:We found no difference in the primary outcome; knee joint load change during walking from a NEMEX program vs information on the recommended use of analgesics and anti-inflammatory drugs. ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012). Ethical Committee: S-20110153. 10.1016/j.joca.2016.10.022
    Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. Villadsen Allan,Overgaard Søren,Holsgaard-Larsen Anders,Christensen Robin,Roos Ewa M The Journal of rheumatology OBJECTIVE:Knowledge about the effects of exercise in severe and endstage osteoarthritis (OA) is limited. The aim was to evaluate the efficacy of a neuromuscular exercise program in patients with clinically severe hip or knee OA. METHODS:This was a randomized controlled assessor-blinded trial. Patients received an educational package (care-as-usual) only, or care-as-usual plus an 8-week neuromuscular exercise intervention (NEMEX-TJR). NEMEX-TJR was supervised by a physiotherapist, twice weekly for 1 h. The primary outcome was Activities of Daily Living (ADL) subscale from the Hip disability and Osteoarthritis Outcome Score (HOOS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. The secondary outcomes were the HOOS/KOOS subscales Pain, Symptoms, Sport and Recreation, and Joint-related Quality of Life. Exploratory outcomes were functional performance measures and lower limb muscle power. RESULTS:Included were 165 patients, 56% female, average age 67 years (SD ± 8), and a body mass index of 30 (SD ± 5), who were scheduled for primary hip or knee replacement. The postintervention difference between mean changes in ADL was 7.2 points (95% CI 3.5 to 10.9, p = 0.0002) in favor of NEMEX-TJR compared with control. Second, there were statistically significant differences between groups in favor of NEMEX-TJR on all self-reported outcomes and most functional performance tests (walk, chair stands, and 1-leg knee bends). Stratified analyses according to joint revealed moderate effect size for ADL for hip patients (0.63, 95% CI 0.26 to 1.00). Corresponding effect size for knee patients was small (0.23 95% CI -0.14 to 0.60). CONCLUSION:Feasibility of neuromuscular exercise was confirmed in patients about to have total joint replacement. Self-reported activities of daily living and objective performance were improved and pain reduced immediately following 8 weeks of neuromuscular exercise. While the effects were moderate in hip OA, they were only small in knee OA. ClinicalTrials.gov Identifier: NCT01003756. 10.3899/jrheum.130642
    One year effectiveness of neuromuscular exercise compared with instruction in analgesic use on knee function in patients with early knee osteoarthritis: the EXERPHARMA randomized trial. Holsgaard-Larsen A,Christensen R,Clausen B,Søndergaard J,Andriacchi T P,Roos E M Osteoarthritis and cartilage OBJECTIVE:To test long-term effectiveness of neuromuscular exercise (NEMEX) with instructions in optimized pharmacological treatment (PHARMA) on activities of daily living (ADL) in patients with early knee osteoarthritis. DESIGN:12-months follow-up from a randomized controlled trial. Participants with mild-to-moderate medial tibiofemoral knee osteoarthritis were randomly allocated to 8 weeks NEMEX or PHARMA. The primary outcome measure was the ADL-subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcome measures included the other four KOOS-subscales, the University of California Activity Score (UCLA) and the European Quality of Life-5 Dimensions. RESULTS:Ninety-three patients (57% women, 58 ± 8 years, body mass index 27 ± 4 kg/m) were randomized to NEMEX (n = 47) or PHARMA group (n = 46) with data from 85% being available at 12-months follow-up. Good compliance was achieved for 49% of the participants in NEMEX (≥12 sessions) and 7% in PHARMA (half the daily dose of acetaminophen/NSAIDs ≥ 28 days). Within-group improvements in NEMEX were considered to be clinically relevant (≥10 points) for all KOOS-subscales, except Sport/Rec whereas, no between-groups difference in the primary outcome KOOS ADL (3.6 [-2.1 to 9.2]; P = 0.216) was observed. For KOOS Symptoms, a statistically significant difference of 7.6 points (2.6-12.7; P = 0.004) was observed in favor of NEMEX with 47% improving ≥10 points. CONCLUSIONS:No difference in improvement in difficulty with ADL was observed. NEMEX improved knee symptoms to a greater extent with half of patients reporting clinically relevant improvements. CLINICALTRIALS. GOV IDENTIFIER:NCT01638962 (July 3, 2012). ETHICAL COMMITTEE:S-20110153. 10.1016/j.joca.2017.10.015
    The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial). Clausen Brian,Holsgaard-Larsen Anders,Søndergaard Jens,Christensen Robin,Andriacchi Thomas P,Roos Ewa M Trials BACKGROUND:Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis. METHOD/DESIGN:One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life. DISCUSSION:These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012). 10.1186/1745-6215-15-444