Is Achilles tendinopathy pain education with or without exercise, more effective than usual care, in improving pain cognitions in those with midportion Achilles tendinopathy? A pilot and feasibility study

This three-arm parallel group feasibility trial will compare three interventions: Arm 1: Achilles Tendinopathy Pain Education (ATPE) Arm 2: Achilles Tendinopathy Pain Education plus Exercise (ATPE+Ex). Arm 3. Usual Care (Exercise + Advice). Each of these three groups will receive one-on-one treatment from a qualified physiotherapist. The ATPE will be based on a previously published protocol.(1) A flexible clinical reasoning approach adopted from cognitive functional therapy has been described in the literature and will be applied to augment this previously published education intervention protocol.(2) This will include: giving space for the participant to provide their story, flexible communication and asking the patient to identify key concerns/priorities and goals.(1) Education will be standardized via pre-recorded modules presented through Microsoft PowerPoint and, also available as a printable pdf document. Whilst education content will be standardized, there will be opportunity for individualized clarification throughout the presentation, as these will be watched in session, alongside the interventionist physiotherapist. Following the slide presentation, the physiotherapist will encourage the patient participant to reflect on the educational content and how it can be applied to their own situation and goals, aligning with the cognitive functional therapy approach.(2) Both the enactment of this self-reflection and the quality of the participants engagement will be assessed as part of the intervention's delivery and receipt fidelity assessment. Interventions: Participants will be randomly allocated to one of the 3 intervention arms (Arm 1 - ATPE, Arm 2 - ATPE+Ex or Arm 3 - usual care) by random number generation. All intervention groups: All interventions will be delivered by AHPRA registered physiotherapists with greater than 5 years' experience. Participants will attend their designated physiotherapist for one session per week for 6 weeks. Interventionist physiotherapists (and their affiliated private practice) will be designated only one treatment arm to prevent between-group contamination. The initial treatment visit will be 30 minutes (ATPE; Usual Care) and 45 minutes (ATPE+Ex) with follow up appointments 20 and 30 minutes respectively. ATPE arm The education intervention will combine elements from pain neuroscience education and cognitive functional therapy and will cover 6 key pain neuroscience elements and 3 cognitive functional therapy elements: The 6 key pain neuroscience elements from Post et al (1) will include: 1. The concept of load and load intolerance in Achilles tendinopathy 2. How to improve Achilles load capacity by progressive exercise & the difference between Achilles tendinopathy & rupture 3. Understanding common Achilles imaging findings 4. Neurobiological pain mechanisms and psychological factors 5. Nervous system sensitivity in persistent pain 6. Benefits of exercise for chronic musculoskeletal pain and Australian Government Physical Activity guidelines Cognitive Functional therapy elements from Kent et al (2): 1. Making sense of pain 2. Exposure with control/graded exposure 3. Lifestyle modifications Achilles Tendinopathy Pain Education (ATPE) as a stand-alone intervention will be a comparator to determine whether any benefits of the combined intervention group are due to the education component or the exercise component. We also wish to determine how well ATPE performs on its own. Session attendance and patient completion of reflective questions will be recorded. ATPE+Ex group All participants assigned to the ATPE+Ex group will receive the same education component delivered to the ATPE group, described above. ATPE+Ex participants will receive an additional 15 minutes of clinical intervention to accommodate the exercise component. Session attendance and patient adherence to their home exercise program will be recorded via the Physitrack App. ATPE+Ex participants will be prescribed an exercise program in accordance with the TEAch protocol. (1) These will be instructed by the same physiotherapist for each session. Exercises will be reinforced by video demonstrations using the Physitrack App (Physitrack PLC, United Kingdom). The exercise intervention will be delivered through three phases: Isometric (for example isometric single leg standing heel raises), isotonic (for example standing or seated heel raises) and plyometric (for example alternating leg hops).(1) Criteria-based progression will occur based on the TEAch protocol (1) Participants will be prescribed there exercise program within this session based on the TEAch protocol. Prescribed isometric exercises will be prescribed 1/day 7/week. Prescribed isotonic exercises will be prescribed 1/day 3/week and plyometric exercises 1/day 2/week. Each home-based exercise session will take approximately 10 minutes. Achilles Tendinopathy Pain Education (ATPE) as a stand-alone intervention will be a comparator to determine whether any benefits of the combined intervention group are due to the education component or the exercise component. We also wish to determine how well ATPE performs on its own. References: 1. Post AA, Rio EK, Sluka KA, Lorimer Moseley G, Bayman EO, Hall MM, et al. Effect of pain education and exercise on pain and function in chronic achilles tendinopathy: Protocol for a double-blind, placebo-controlled randomized trial. JMIR Research Protocols. [Article]. 2020;9(11). 2. Kent P, Haines T, O'Sullivan P, Smith A, Campbell A, Schutze R, et al. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial. Lancet. [Article]. 2023;401(10391):1866-77.