None listed
Conditions
Brief summary
Osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in older adults. The prevalence of knee OA is as high as 50-90% a decade after anterior cruciate ligament injury, irrespective of conservative or surgical management (ACL reconstruction). Our recent magnetic resonance imaging (MRI) data has revealed evidence of OA as early as one year post-ACLR in up to one-third of younger adults – “young people with old knees.” This early-onset OA is frequently associated with pain, reduced physical function, and ultimately, decreased quality of life (QoL) in people aged less than 50 years.Therefore, interventions with potential to reduce pain, improve function and optimise QoL in this population are urgently required. It is known that individuals most at risk of persistent and worsening knee symptoms after ACLR were those with poor knee function 12 months post-and these individuals are more likely to have deteriorating quality of life over the following two years. Post-operative ACLR rehabilitation programs typically aim to decrease pain and improve function to ultimately facilitate a return to competitive sport during the first 12 months post-surgery. There is strong evidence that rehabilitation programs, including progressive resistance and neuromuscular training, have beneficial effects on pain and knee function in patients following rupture of the ACL. However, optimal function and return to sport is not restored in many individuals at 12 months post ACLR, potentially reflecting inadequate rehabilitation participation, and/or insufficient strength/neuromuscular exercise progression. The 12-months post-surgical milestone provides an ideal window to identify those with functional impairments who are at risk of symptomatic deterioration and for interventions that target this group to be implemented. No studies have examined either the feasibility or effectiveness of physiotherapy treatment that aims to enhance self-reported outcomes by targeting specific dysfunction in patients who have persistent functional impairments following ACLR. We hypothesise that a targeted physiotherapy program will improve outcomes in those that are at risk of deteriorating symptoms and early OA following ACLR compared to a control group, who do not receive targeted physiotherapy. The outcomes that we are interested in improving are self reported symptoms, function/return to sport, and quality of life. We will also be assessing whether gains can be made in strength and neuromuscular control at this 12-month post ACLR stage, and whether this is related to improvements in the self reported outcomes. We hypothesise that both groups will improve, however the targeted physiotherapy group will have significantly more gains.
Interventions
The targeted physiotherapy intervention group will complete eight 1:1 physiotherapy sessions (duration = 30 minutes) over 16 weeks, (1 x week for 4 weeks, then every 3 weeks for 12 weeks). These sessions will be conducted at BodySystem sports medicine clinic by two experienced physiotherapists (>5 years clinical experience in treating lower limb musculoskeletal conditions). This will occur immediately following a baseline assessment session with investigator BH at 12 months post ACLR.
Physioth
The targeted physiotherapy intervention group will complete eight 1:1 physiotherapy sessions (duration = 30 minutes) over 16 weeks, (1 x week for 4 weeks, then every 3 weeks for 12 weeks). These sessions will be conducted at BodySystem sports medicine clinic by two experienced physiotherapists (>5 years clinical experience in treating lower limb musculoskeletal conditions). This will occur immediately following a baseline assessment session with investigator BH at 12 months post ACLR. Physiotherapy in this pilot RCT will have a distinct focus on functional retraining split into “progressive phases”. These phases are similar to a neuromuscular retraining intervention that has led to clinically meaningful changes in self-reported QoL in knee injury populations (articular cartilage lesions) with ongoing functional deficits following a similar period of routine rehabilitation. There are 7 main "tasks" or exercises: 1. Balance 2. Functional strength 3. One Leg Rise 4. Posterior chain strength 5. Power 6. Multidirectional Movement 7. Sport Specific/Cardiovascular exercise Each task, will have progressive phases within it. For example, "one leg rise" will start at phase one of a bilateral sit to stand, then once the pass criteria is met (x 30 to 90 degrees, nil pain or response in the knee), they move to an assisted one leg rise, then to an unassisted one leg rise, then to a single leg squat, then to a star excursion exercise. The 7th category of "sport specific/cardiovascular exercise," is also phased. For example, they may not have began running, so phase 1 starts at walking/bike/swimming, then once they have passed the criteria (range of strength, control and balance tests) they may move to running. See attached document for working examples of the above described Tasks – One Leg Rise and Sport Specific/Cardiovascular. The 1:1 physiotherapy sessions will be used to review the rehabilitation program. They will be given the appropriate exercises from each of the 7 tasks to perform at home. These home exercise sessions will be approximately 30 -45 minutes depending on the level of the patient. Tasks 1-5 must be completed at a minimum of 3 times per week, maximum of 5, at the discretion of the physiotherapist and patient. For tasks 6 and 7, as this may involve some agility exercises, running or sport specific drills, this will completed in addition to Tasks 1 -5 and up to the discretion of the physiotherapist, pending on the level of the patient. If the patient is at a lower level then they may be doing bike in Task 7, and therefore this could be completed at the same time as their exercises in Tasks 1 – 5, i.e. minimum 3 times a week, maximum of 5, at discretion of physiotherapist. However, if the patient is at the higher level, they may perform exercises (Task 1 -5) 3 x week, and then perform x 2 running and agility sessions on top of this. The duration and frequency of these sessions will vary depending on the level of the patient, and will be up to the discretion of the treating physiotherapist. Participants will be required to keep a "log book" to measure compliance of their home exercise program via the app on their smart device/computer. They will also have the option of paper version if not able to use the app. In addition to compliance, use of medications, other treatments, and symptoms will be monitored. Physiotherapists will also mark attendance at each of the physiotherapy sessions. They will also perform standardised assessment (balance, strength, function) at each physiotherapy session, which may improve adherence, This will be recorded by the physiotherapists in a log book. Education component: - Session 1: Increased risk of OA is not decreased with ACLR and important to have strong muscles to support knee. Understanding of OA pathology and progression. Session 2: Benefits of physical activity – strength gains, decreased joint load, weight loss, evidence based conservative management for osteoarthritis. Fear avoidance addressed as appropriate. Why the exercises they are prescribed are important - Session 3: Benefits of improving diet, weight loss, neuromuscular benefits, natural anti-inflammatory foods, and role in management of joint health. Benefits of dietician management and referral advice as appropriate. - Session 4: Activity level modification advice as appropriate and return to sport/activity education – need to be >90% than other limb on certain tests. Patients’ specific goals and how to most appropriately achieve these. Benefits of psychology in returning to sport/activity and goal setting. This will be delivered via an information booklet in the first session. And then verbal discussion of each of the topics in 5 – 10 minute blocks at each of the following 1:1 physiotherapy sessions. This will also direct them to external resources such as: http://daa.asn.au/for-the-public/smart-eating-for-you/
Sponsors
Professor Kay Crossley
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
(i) aged 18-50 years; (ii) primary arthroscopic ACLR with a hamstring-tendon autograft 6 months prior; (iii) evidence of poor knee function at 12 months as defined by: < 87.5 on KOOS-QoL score AND meeting one the following three criteria: 1. <22 on the one leg rise task OR 2. <88% LSI on single leg hop for distance 3. <87 on the AKP scale Please note that patients will be recruited at 6 months post ACLR into a recruitment pool. From this point we will monitor their activity level from 6 -12 months as it has been shown significant bone and cartilage changes occur in this time point, and it has been suggested that those that participate early in cutting/impact activities may have greater changes. At 12 months, each patient who had agreed to be contacted for eligibility at 12 months will be re contacted, The patients will then be invited to attend an eligibility testing session at BodySystem clinic, of which the KOOS- QoL, one leg rise, single hop for distance and AKP scale will be administered by a physiotherapist who will not be involved in the treatment intervention. If eligible they will book an appointment for physiotherapy 1:1 session, to begin as soon as possible. Note: The patients will be informed on the possibility at 6 months that they may not be eligible for the study.
Exclusion criteria
(i) previous injury/symptoms in the ACL injured knee; (ii) >5 years between ACL injury and reconstruction; (iii) subsequent injury (for which medical treatment was sought) or follow-up surgery to the ACLR knee; (v) another condition influencing daily function; (iv) inability to understand written and spoken English.
Outcome results
None listed