None listed
Conditions
Brief summary
This is the first pragmatic randomised trial to comparatively investigate Ethanol ablation and Radiofrequency ablation for the treatment of chronic Morton’s neuroma. This study was deemed necessary as no prospective studies compare Ethanol ablation with Radiofrequency ablation or focus on patient recorded outcome measures, specifically measuring pain, foot health, function and ability.
Interventions
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
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.
Sponsors
Imaging Central
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 six months. 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.
Exclusion criteria
Participants were excluded from the study if they had a diagnosis of a chronic condition that may affect levels of pain and foot function, such as; foot or ankle osteoarthritis; inflammatory arthropathy; peripheral vascular disease; diabetes; neurological abnormalities; malignancies; sciatica or chronic pain conditions; active infection of the foot in the skin, soft tissues or bone; open wounds/sores on foot in the area where the injection is to be applied; history of recent foot trauma, foot surgery, stress fracture or tendon rupture including surgery for Morton’s neuroma; double neuromas; inability to understand instructions or complete a questionnaire.
Outcome results
None listed