Efficacy of Tendon Strip Injections compared to sham following failure of conservative therapy for Achilles tendinopathy

INTERVENTION: A single TSI or sham injection will be delivered by a radiology nurse and experienced musculoskeletal radiologist.Three injection groups (i) Tendon strip injection with steroid: The TSI consists of five syringes, the first with exactly 10 mL of 0.5% bupivacaine hydrochloride and 25 mg of hydrocortisone (the syringe will be large enough to take both the local anaesthetic and steroid), followed by four syringes with 10 mL each of normal saline. The TSI will be injected into the interface between Kager’s fat and the Achilles tendon. The local anaesthetic + the steroid, followed by the four saline syringes are injected consecutively by using a connecting tube (allows consecutive syringes to be attached). The position of the needle is monitored continuously by ultrasound and the needle is moved gently across the anterior aspect of the tendon to ensure uniform effect over the pathological area. Including our preliminary trials and the prior case series on TSI there are over 175 participants who have had this procedure, with no reports of serious complications (e.g. tendon rupture, infection). (ii) Tendon strip injection without steroid: This injection is identical to the TSI with steroid, but the first syringe will only contain exactly 10 mL of 0.5% bupivacaine hydrochloride (no steroid). (iii) Sham injection: The sham injection consists of five syringes like the tendon strip injection. The first contains 2‐3 mL of 0.5% bupivacaine hydrochloride. The subsequent four syringes contain 0.25mL of normal saline (i.e a few drops). Total volume is 3‐4mL. The sham will be injected under image guidance by the same expert radiologist, deep to the tendon and away from the interface between Kager’s fat and the Achilles tendon (at last 5mm away). The sham injection will result in a numbing effect, like the TSI. Immediately post injection participants will be asked which injection they believe they received to assess the success of participant blinding. Post injection trea CONDITION: Achilles Tendinopathy; ; Achilles Tendinopathy Injuries and Accidents ‐ Other injuries and accidents Musculoskeletal ‐ Other muscular and skeletal disorders SECONDARY OUTCOME: Achilles tendon thickness and Doppler signal: An experienced musculoskeletal ultrasonographer blind to treatment allocation will assess Achilles tendon thickness and Doppler signal (a marker of the degree of neurovascular ingrowth) on ultrasound imaging using reliable methods. Doppler signal will be assessed by quantifying pixel count. ; ; It's a composite secondary outcome.[baseline, 6, 12, 26 and 52 weeks] Adverse event: An adverse event is defined as any unfavourable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention (e.g. tendon rupture, fall, injury, or change in medical status). ; It will be measured using an Adverse events questionnaire, which was designed specifically for this study.[every 4 weeks from week 4 to 52 via online questionnaire (if not coinciding with an assessment visit time). ; INCLUSION CRITERIA: • Previously trialled first line recommended treatment • Aged 18 years or above • more than 3 months of pain in the mid‐portion Achilles area proximal to the Achilles tendon insertion in the calcaneum) • Primary complaint of mid‐portion Achilles pain on one or both lower limbs • VISA‐A <75 points • Clinical diagnosis of mid‐portion Achilles tendinopathy based on the following criteria: o Gradual onset pain in the relevant area; o Midportion Achilles pain during or after Achilles tendon loading activities (e.g. walking, running) • Ankle joint examination, and especially passive plantar‐flexion is essentially normal, • Confirm diagnosis with ultrasound imaging of the Achilles tendon. One or more of the PRIMARY OUTCOME: Primary outcome: Pain and function will be assessed with the VISA‐A, a well validated, reliable and disease‐specific tool. This outcome includes pain, function and activity domains that are clinically relevant to patients with Achilles tendinopathy. Scores range from 0 to 100, with 100 indicating no symptoms or function/activity limitations. ; The final two question of the VISA‐A were designed for sporting populations and will be modified in our study to relate to our mixed sporting and non‐sporting population. Question 7 will be modified from ‘Are you currently undertaking sport or other physical activity?’ to ‘Are you currently undertaking sport or other physical activity, including walking?’. Question 8 asks about pain and disability during Achilles tendon loading sport. ‘Achilles tendon loading sport’ will be changed to ‘weight‐bearing activity’. Both versions of question 8 will be included so that responsiveness of both versions of the VISA‐A can be evaluated. ; ; It's a composite primary outcome.[baseline, 6, 12, 26 and 52 weeks] ; It's a composite secondary outcome.[baseline, 6, 12, 26 and 52 weeks] Overall pain intensity: Measured using the 100 mm visual analogue scale (VAS), participants will rate the worst pain during the last week (zero = no pain; 100 = worst pain possible). [baseline, 6, 12, 26 and 52 weeks] Pain self efficacy: Assessed with the pain self‐efficacy questionnaire (PSEQ). The PSEQ measures how confident a patient is in undertaking a range of activities despite their pain. [baseline, 6, 12, 26 and 52 weeks] Productivity (including absenteeism and presentism) will be measured using the ‘iMTA Productivity Cost Questionnaire’. [every 4 weeks from week 4 to 52 via online questionnaire (if not coinciding with an assessment visit time).] The Global Rating of Change Scale (GROC) is an 11‐point scale in which the participant is asked to rate their perceived overall change in their Achilles tendinopathy condition from the time that they began the study until the present, as Worse, No Change, or Better. If they indicate worse, the patient will then be asked how much worse on a five‐point scale from Very Much Worse to Slightly Worse, and if they are better, they will be asked how much better on a five‐point scale from Slightly Better to Very Much Better.[6, 12, 26 and 52 weeks] The level of physical activity in the previous week: Evaluated using the 7‐day Recall Physical Activity Questionnaire, a valid and reliable tool. Participants will be asked to recall time spent sleeping and doing physical activity (work, leisure, household activities) over the past 7 days. [baseline, 6, 12, 26 and 52 weeks] following features present in the mid‐portion area: (i) hypoechoic regions; and/or (ii) Doppler signal indicative of vascularisation. ; ] Catastrophising: The Pain Catastrophising Scale is a validated questionnaire used to measure pain catastrophisation.. [baseline, 6, 12, 26 and 52 weeks] Exercise adherence: Participants will record the number of exercise sessions completed each week over the previous four weeks (adherence is the percentage of prescribed sessions that are completed). [every 4 weeks from week 4 to 52 via online questionnaire (if not coinciding with an assessment visit time).] Fear avoidance: The Tampa Kinesiophobia Scale is a validated questionnaire used to measure fear‐avoidance. [baseline, 6, 12, 26 and 52 weeks] Health‐related quality of life: Measured with the EuroQol 5D‐5L, a validated and reliable tool, including five domains (mobility, self‐care, usual activities, pain/discomfort and anxiety/depression), and a rating of overall health state from 0 (worst health state imaginable) to 100 (best imaginable health state) using a VAS. [baseline, 6, 12, 26 and 52 weeks] Healthcare use: Medicare Benefits Schedule and Pharmaceutical Benefits Schedule data will be extracted to measure use of subsidised healthcare services. [At 12 months for the preceeding 12 months] Healthcare use: Participants will be asked to answer yes or no to whether they have used any health services or co‐interventions over the last 4 weeks. if they answer yes details will becollected via a follow up telephone call. [every 4 weeks from week 4 to 52 via online questionnaire (if not coinciding with an assessment visit time).] Maximal voluntary isometric contraction (MVIC) and rate of force development (RFD): Seated calf raise rate of force development (RFD) and maximal voluntary isometric contraction (MVIC). Standard strength (MVIC and RFD) tests will be performed on a custom chair equipped with a force plate that measures plantarflexor force. Participants will have an adequate warm up (>5 minutes of cycling at a moderate intensity, based on a reported Borg Scale rating of perceived exertion of 6‐7/10) and then perform 4 practice and 2 recorded trials. The instructions will be 'push as hard and fast as possible'.