Background: Total knee arthroplasty (TKA) is considered an effective treatment for pain relief and improved physical performances in end-stage knee osteoarthritis. However, several studies have reported less favorable outcomes after TKA with chronic pain rates of approximately 20%. Exercise might be an effective treatment strategy for chronic pain following TKA, but no randomized controlled trials have evaluated its effect. Therefore, the purpose of this randomized controlled trial is to investigate whether a 12-week neuromuscular exercise (NEuroMuscular EXercise training program for patients with knee or hip osteoarthritis assigned for total joint replacement; NEMEX-TJR) program combined with pain neuroscience education (PNE) provides greater pain relief and improvement in physical performances than PNE alone at 12 months follow-up in a population of patients with chronic pain after primary TKA. Methods: For this randomized controlled superiority trial, 120 patients with moderate-to-severe chronic pain after TKA are recruited from Aalborg University Hospital, Denmark. Patients are randomly assigned in a 1:1 ratio to one of two interventions: (a) NEMEX-TJR twice weekly for 12 weeks combined with two sessions of PNE or (b) two sessions of PNE given over 6 weeks. Assessment is performed at baseline before intervention and at 3, 6, and 12 months after initiation of the intervention. Outcome assessors are blinded toward group allocation. The primary outcome is the change in the Knee Injury and Osteoarthritis Outcome Score 4 (KOOS 4), defined as the mean score for the KOOS subscales pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include all KOOS subscale scores and scores for PainDETECT, the Fear-Avoidance Beliefs Questionnaire, Global Perceived Effect, the Pain Catastrophizing Scale, pain intensities, temporal summation, conditioned pain modulation, and pressure pain thresholds. Physical performances are measured with walking, stair climbing, and chair standing tests as well as tests of muscle strength and power.
AbstractBackground and aimsConditioned pain modulation (CPM) is of considerable interest within pain research. Often CPM testing is conducted in experimental settings using complicated instrumentation, thus challenging the implementation in clinical settings. Being able to assess CPM in a fast and reliable way in clinical settings could lead to a new diagnostic tool allowing improved profiling of pain patients.MethodsA test-retest reliability study and a methodological development study were conducted based on different populations. The reliability study included 22 healthy subjects, mean age 23.6 years (SD: 2.4) and the methodological study included 29 healthy subjects, mean age 21.5 years (SD: 1.6). As painful phasic test stimulus, a 6–10 kg handheld, spring-based pressure algometer was applied perpendicularly to the muscle belly of the tibialis anterior muscle for 10 s and as painful tonic conditioning stimulus, 1–2 standard clamps, inducing a force of 1.3 kg, were applied extra-segmentally at the ipsilateral earlobe for 60–120 s. Four different test protocols were evaluated, of which one protocol was investigated for reliability. Test protocol 1 used a 6 kg pressure algometer as painful phasic test stimulus and a single clamp applied for 60 s as painful tonic conditioning stimulus. Test protocol 2 used a 10 kg pressure algometer as painful phasic test stimulus, and two clamps applied for 60 s as painful tonic conditioning stimulus. Test protocol 3 used a 10 kg pressure algometer as painful phasic test stimulus and a single clamp applied for 120 s as painful tonic conditioning stimulus. Test protocol 4 used a 6 kg pressure algometer as painful phasic test stimulus and a single clamp applied for 120 s as painful tonic conditioning stimulus.ResultsNone of the stimuli caused any adverse events, e.g. bruises. In the reliability study (test protocol (1), non-significant CPM effects of 0.3 (SD: 1.6) and 0.2 (SD: 1.0) were observed in session 1 and 2, respectively. The intra-class correlations were 0.67 and 0.72 (p = < 0.01) and limits of agreement (LoA) ranged from −2.76 to 3.31. Non-significant CPM effects of 0.2 (SD: 1.0), −0.1 (SD: 1.1), and 0.0 (SD: 1.2) were observed for test protocol 2, 3, and 4, respectively).ConclusionsThe bedside test developed for investigating CPM was feasible and easy to use in healthy volunteers. No significant CPM effects were measured and a large variation in CPM effect ranging from −0.14 to 0.32 was observed. Intra-class correlation (ICC) values for the pressure algometer were interpreted as “good relative reliability” (test protocol 1), and LoA revealed a somewhat low absolute reliability.ImplicationsThe pressure algometer provided reproducible measurements and was useful for inducing phasic test stimuli. Since no significant CPM effects were detected, no recommendations for the bedside test can yet be made. Further examinations will have to establish if the “one size fits all” application of both test and conditioning stimuli is useful. Future bedside studies involving patient populations are warranted to determine the usefulness of the method.
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