Optimisating corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A randomised control trial with placebo comparison.

INTERVENTION: All participants in the study will be warned that pain‐provoking activities should be avoided, especially if the provoked pain persists for longer than several minutes. They will also be advised that complete rest is extremely detrimental to musculoskeletal disorders and that activity that does not create pain in the elbow should be encouraged. There will be four groups: (a) corticosteroid injection only, (b) corticosteroid injection plus physiotherapy, (c) saline injection, and (d) saline injection and physiotherapy. The corticosteroid injection and physiotherapy are described here and saline below in the comparator condition. Corticosteroid injection: This involves the placement of the corticosteroid injection into the most‐tender palpable point(s) of the lateral elbow in the region of the lateral humeral epicondyle. The single injection consists of a 1 ml quantity of 1% lignocaine with 10mg of triaminolone acetonide in 1 ml. Participants will be advised to gradually return to normal activities and not to aggressively pursue return of normal activities even if they were pain free. Prior to the injection the practitioner will perform a routine clinical examination as would be regarded best clinical practice. The protocol has been previously followed in Bisset et al (2006, BMJ 333(7575): 939‐41). Physiotherapy: Physiotherapy will be as recently evaluated by Bisset et al (2006, BMJ 333(7575): 939‐41), which consists of specific elbow manipulation know as mobilisation with movement and a customized therapeutic exercise program (Vicenzino 2003 Manual Therapy 8(2): 66‐79) under the guidance of a physiotherapist over 8 thirty minute sessions in 8 weeks (Vicenzino and Bisset 2007, EBM 12: 37‐8). Participants are required to perform a home program of exercises and self manipulation twice daily, each session lasting approximately 20 minutes for the duration of the study. The program will be taught by the therapist and progressed at the physiotherapy treatment sessions, as per a standardised protocol, which is based on the status of the condition and its response to the previously prescribed exercise and self manipulation. Program adherence will be facilitated by attendance at the regular therapist sessions, as well as the provision of exercise equipment (e.g., elasticised resistance exercise band(s)) and an exercise booklet. Timing of measures: The injection will be performed within 10 days of randomisation. Participants receiving physiotherapy will commence their first session prior to injection and second session one week following injection, with the remaining 6 sessions completed by 8 weeks post randomisation. Hence participants receiving injection alone will complete their treatment with 10 days, while those receiving injection with physiotherapy will complete treatment by 8 weeks. CONDITION: Lateral Epicondylalgia Tennis Elbow PRIMARY OUTCOME: General improvement (6‐point scale: completely recovered, much improved, improved, no change, worse, much worse) Pain‐free Grip Force INCLUSION CRITERIA: Lateral elbow pain of greater than 6 weeks duration and satisfying widely accepted diagnostic criteria for tennis elbow: (a) pain over the lateral humeral epicondylar region, (b) pain that is provoked by gripping activities, (c) reduced grip strength, and (d) increased sensitivity to manual palpation over the lateral epicondylar region. Reproduction of pain with stretching of the forearm extensor muscles or with specific resisted static contraction of extensor carpi radialis brevis is also usually present. SECONDARY OUTCOME: Contingent valuation will be performed at baseline using a willingness to pay questionnaire and structured interview to elicit a participants' monetary valuation of a healthcare intervention, standardised by use of a hypothetical scenario. Starting bids will be randomised according to a computerised number generation to minimise bias. Costs will be measured from a societal perspective by a standardised telephone interview requesting information about expenses incurred over the preceding month. Data will include including a) direct health care costs, such as visits to doctors, therapists, investigations and prescribed medication; b) direct non‐health care costs, such as costs of over‐the‐counter medication, hours of paid and unpaid household help, transportation and other out‐of‐pocket expenses; c) indirect costs, such as absence from work, housekeeping and other daily activities. Elbow Flexion and Extension Isometric Strength will be measured in standing with the elbow positioned in 90 degrees flexion and neutral shoulder and forearm pronation/supination. A dynamometer attached to a frame will allow measurement of force applied at the wrist during either flexion or extension (in kilograms). Participants will be instructed to maintain upright position (no formal fixation of posture will occur). As gripping is pain provoking in participants with lateral epicondylalgia, participants will be instructed to avoid making a fist during the test. European Quality of Life Measurement (EuroQol) Hospital Anxiety and Depression Scale (HADS) Patient‐rated tennis elbow evaluation questionnaire (PRTEE) Pressure Pain Threshold will be measured using a Somedic algometer with 1cm2 probe size applied at a rate of 40kPa/s immediately anterior to the lateral epicondyle. The end point of this test is when the participant willl press a button when the sensation of pressure changes to one of pressure and pain. Triplicate measures will be performed. Severity of resting pain and worst pain and functional capacity measured on an 10cm pain visual analogue scale Tampa Scale of Kinesiophobia (TSK): will be administered at baseline to assess the degree of kinesiophobia, also known as fear of movement or (re)injury. Thermal (heat and cold) Pain Threshold will be measured using a Somedic Thermotest system which will adjust the temperature of the probe applied to the lateral epicondyle region at a rate of 1‐2degrees/second. The end point of this test is when the participant first notes the sensation of pain by pressing a button.