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Trial registered on ANZCTR


Registration number
ACTRN12622000912785
Ethics application status
Approved
Date submitted
16/06/2022
Date registered
27/06/2022
Date last updated
27/06/2022
Date data sharing statement initially provided
27/06/2022
Date results information initially provided
27/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pragmatic Equivalence Trial to Investigate the Effectiveness of Ultrasound Guided Ethanol Ablation & Radiofrequency Ablation for the Treatment of Chronic Morton’s Neuroma
Scientific title
A Pragmatic Equivalence Trial to Investigate the Effectiveness of Ultrasound Guided Ethanol Ablation & Radiofrequency Ablation for the Treatment of Chronic Morton’s Neuroma
Secondary ID [1] 307366 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morton's Neuroma 326677 0
Condition category
Condition code
Musculoskeletal 323917 323917 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323795 0
Treatment: Other
Comparator / control treatment
Radiofrequency ablation: Under ultrasound guidance, a sterile radiofrequency needle probe (20g 6cm needle with 10mm electrode tip) was inserted between the toes into the affected webspace and the Morton’s neuroma. Three cycles with each cycle of two minutes duration were applied, with the probe tip maintaining a temperature of 80-85 and 90 degrees Celsius respectively on each cycle, using Bayliss Pain Management Generator. A second application may be applicable for those with partial pain relief.
Radiofrequency was administered by an Interventional Radiologist who was trained in such techniques. Up to 2 sessions may be required pending symptomatic response, Radiologist determines the need for further injection.
Control group
Active

Outcomes
Primary outcome [1] 331724 0
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.
Timepoint [1] 331724 0
One week, four weeks, three months and six months post intervention commencement.
Primary endpoint of six-months.
Primary outcome [2] 331725 0
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.
Timepoint [2] 331725 0
One week, four weeks, three months and six months post intervention commencement.
Primary endpoint of six-months.
Primary outcome [3] 331726 0
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.
Timepoint [3] 331726 0
One week, four weeks, three months and six months post intervention commencement.
Primary endpoint of six-months.
Secondary outcome [1] 410873 0
Not applicable
Timepoint [1] 410873 0
Nil

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent was obtained, and randomisation for group allocation was performed with a computer generated sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data were analysed using SPSS (v.19, SPSS for Windows, Armonk, NY: IBM Corp) for windows. Data analysis followed an intention to treat analysis, where all randomised participants were included. For missing data, predictive mean matching was applied. This method imputes missing values by means of the nearest neighbour donor with distance expected on the expected values of the missing variables conditional on the observed covariates. This allows for sufficient power and reduction in Type 1 errors. During the six month follow-up period there were incidence of missing variables due to non-completion. All data was analysed to determine the pattern of missing values. Baseline descriptive information (gender, age, weight, height, waist to hip ratio, duration of symptoms, previous treatment, foot posture index) was displayed as means and standard deviations (SD). All data were assessed for normal distribution using Levene's Test for Equality of Variances. Within-group analysis was performed using paired sampled t-tests at three and six months, and between-group analysis employed independent t-tests at three and six months. P-values were set at 0.05

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
25/05/2015
Date of last participant enrolment
Anticipated
Actual
30/07/2016
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
132
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311648 0
Commercial sector/Industry
Name [1] 311648 0
Imaging Central
Country [1] 311648 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Imaging Central
Address
345 Stirling Highway, Claremont WA 6010
Country
Australia
Secondary sponsor category [1] 313092 0
None
Name [1] 313092 0
Address [1] 313092 0
Country [1] 313092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311104 0
University of Western Australia Research Ethics Committee
Ethics committee address [1] 311104 0
35 Stirling Highway, Nedlands WA 6009
Ethics committee country [1] 311104 0
Australia
Date submitted for ethics approval [1] 311104 0
17/12/2014
Approval date [1] 311104 0
22/05/2015
Ethics approval number [1] 311104 0
RA/4/1/7299

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119958 0
Dr Renee Silvester
Address 119958 0
Podiatric Medicine and Surgery Division
School of Allied Health
1 Crawley Ave, Nedlands WA 6009
Country 119958 0
Australia
Phone 119958 0
+61438222454
Fax 119958 0
Email 119958 0
renee.silvester@uwa.edu.au
Contact person for public queries
Name 119959 0
Dr Renee Silvester
Address 119959 0
Podiatric Medicine and Surgery Division
School of Allied Health
1 Crawley Ave, Nedlands WA 6009
Country 119959 0
Australia
Phone 119959 0
+61438222454
Fax 119959 0
Email 119959 0
renee.silvester@uwa.edu.au
Contact person for scientific queries
Name 119960 0
Dr Renee Silvester
Address 119960 0
Podiatric Medicine and Surgery Division
School of Allied Health
1 Crawley Ave, Nedlands WA 6009
Country 119960 0
Australia
Phone 119960 0
+61438222454
Fax 119960 0
Email 119960 0
renee.silvester@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent was not obtained for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16403Ethical approval    384225-(Uploaded-16-06-2022-17-24-48)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.