A Pragmatic Equivalence Trial to Investigate the Effectiveness of Ultrasound Guided Ethanol Ablation & Radiofrequency Ablation for the Treatment of Chronic Morton’s Neuroma

INTERVENTION: Ethanol Ablation: Under ultrasound guidance, a solution of 0.1mL of 96% ethyl alcohol diluted in 0.7mL of 0.5% bupivacaine (total = 0.8 mL of 12% ethyl alcohol was slowly injected into the Morton's Neuroma. This was repeated up to four occasions every two weeks. Ethanol was administered by an Interventional Radiologist who was trained in such techniques. Total dosage, 4 injections were required 2 weeks apart. No strategies to monitor adherence, all participants completed dosage. Total duration of procedure up to 45 minutes. CONDITION: Morton's Neuroma; ; Morton's Neuroma Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: 1. Foot Health Status Questionnaire (FHSQ); A self‐administered form with 13 questions spanning eight domains of foot health: foot pain, foot function, shoe, general foot health, general health, physical activity, social capacity and vigour was provided to each participant. The participant indicated their response to the question on a five‐point Likert scale. The FHSQ has been validated (content, criterion and construct validity) and is excellent for test‐retest reliability with an intraclass coefficient of 0.86. The effect of each intervention can be individually determined against each domain. [One week, four weeks, three months and six months post intervention commencement. ; Primary endpoint of six‐months. ] 2. Visual analogue scale (VAS) ; This is a self‐administered form that is assessed on a 100mm VAS. The participant indicated the severity of pain within the last 24 hours. The scale is a continuum starting at 0mm, indicating no pain (left side), to 100mm, indicating the worst pain imaginable (right side). The VAS is a commonly used tool that is valid and reliable. [One week, four weeks, three months and six months post intervention commencement. ; Primary endpoint of six‐months. ] 3. Foot and Ankle Ability Measure (FAAM); The FAAM is a self‐administered tool used to evaluate a participant's ability to perform activities of daily living. This tool is specific for musculoskeletal conditions affecting the foot, ankle and lower limb. Participants were required to indicate their current level on a scale of six criteria ranging from; no difficulty to unable to perform. The FAAM is a reliable, valid and responsive measure of self‐reported physical ability. [One week, four weeks, three months and six months post intervention commencement. ; Primary endpoint of six‐months. ] SECONDARY OUTCOME: Not applicable [Nil] INCLUSION CRITERIA: Participants were included in the study if they were 18 years old and over and had a confirmed diagnosis of Morton’s neuroma as determined by the clinical assessment and diagnostic ultrasound with symptom duration greater than or equal to si Xmonths. Failed conservative treatments, which may include corticosteroid injections, footwear modification and orthotics, was another inclusion criterion. Participants also needed to have an ability to speak, read and write English and be capable of walking 50 meters with the aid of support and able to attend all scheduled appointments.