Patterson Brooke E, Barton Christian J, Culvenor Adam G, Cooper Randall L, Crossley Kay M
La Trobe Sport & Exercise Medicine Research Centre, School of Allied Health, Humans Services and Sport, La Trobe University, Bundoora, 3086, Australia.
BMC Musculoskelet Disord. 2021 Jan 11;22(1):64. doi: 10.1186/s12891-020-03919-6.
Guided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function.
Participant- and assessor-blinded, pilot feasibility RCT.
Participant eligibility criteria: i) 12-15 months post-ACLR; ii) < 87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and either a one-leg rise test < 22 repetitions, single-hop < 90% limb symmetry; or Anterior Knee Pain Scale < 87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (> 1 in 3 screened), recruitment rate (> 4 participants/month), retention (< 20% drop-out), physiotherapy attendance and unsupervised exercise adherence (> 80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval.
47% of those screened were eligible, and 27 participants (3 participants/month; 48% men, 34±12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was > 80% for both groups but reported adherence to unsupervised exercise was low (< 55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance.
A larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect.
Prospectively registered ( ACTRN12616000564459 ).
尽管前交叉韧带重建术（ACLR）后出现不可接受症状和生活质量（QoL）问题的比例很高，但6个月后的指导性康复却很少见。我们的主要目的是确定一项随机对照试验（RCT）的可行性，该试验评估针对ACLR术后1年仍有持续症状的个体进行的物理治疗师指导干预。我们的次要目的是确定与以躯干为重点的干预相比，针对下肢的干预是否能在改善膝关节相关的生活质量、症状和功能方面观察到有价值的治疗效果。
参与者和评估者双盲的试点可行性随机对照试验。
参与者纳入标准：i）ACLR术后12 - 15个月；ii）膝关节损伤和骨关节炎结局评分（KOOS）生活质量子量表得分<87.5/100；单腿抬高试验<22次重复、单跳<肢体对称性的90%；或前膝疼痛量表<87/100。参与者被随机分配到下肢或躯干重点的运动和教育组。两种干预均包括在16周内进行8次面对面物理治疗。通过纳入率（>1/3筛查者）、招募率（>4名参与者/月）、保留率（<20%退出）、物理治疗出勤率和无监督运动依从性（>80%）来评估可行性。使用膝关节相关生活质量（KOOS - QoL、ACL - QoL）、症状（KOOS - Pain、KOOS - Symptoms）和功能（KOOS - Sport、功能性能测试）的组间差异来验证95%置信区间内是否包含有价值的效果（大于每个测量指标的最小可检测变化）。
47%的筛查者符合条件，27名参与者（3名参与者/月；48%为男性，34±12岁）被随机分组。2人未开始治疗，2人失访（16%退出）。两组物理治疗出勤率均>80%，但报告的无监督运动依从性较低（<55%）。两种干预对KOOS - QoL和ACL - QoL均有潜在的有价值效果，而针对下肢的干预对KOOS - Sport、KOOS - Pain和功能性能可能有更大效果。
有必要进行更大规模的随机对照试验。所有可行性标准均已满足，或可提出合理建议以便在未来试验中达到这些标准。需要增加招募率和运动依从性的策略。膝关节相关生活质量、症状和功能的潜在有价值效果表明，一项充分有力的随机对照试验可能检测到具有临床意义的效果。
前瞻性注册（ACTRN12616000564459）
