Morton's Neuroma: Manipulation Versus Steroid Injection
United Kingdom64 participantsStarted 2015-10
Plain-language summary
The aim of this study is to establish which of two treatment options is the preferred intervention in the treatment of Morton's Neuroma.
A randomised controlled trial shall be performed. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, manipulation shall be compared to a control group receiving a steroid injection in an equality randomised controlled trial.
Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS of 20mm above the other group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.
There is limited research evidence to support the management of Morton's neuroma with steroid injection although its efficacy has only been demonstrated in the short term.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion criteria shall be any positive clinical sign together with a positive diagnostic ultrasound giving rise to a diagnosis of Morton's neuroma/plantar digital neuritis.
* A VAS score of no less than 25/100 will also be required.
* All subjects must be over 18 years of age and able to offer informed consent.
Exclusion Criteria:
* Absolute exclusion criteria will include Rheumatoid Arthritis, recent (less than 3 months) fracture to the affected foot, peripheral neuropathy, localised infection, pregnancy, allergy to Methylprednisolone.
* Allergy to local anaesthetic.
* Further exclusion criteria include Active infection
* Diabetes mellitus
* Ulcerative colitis
* Diverticulitis
* Hypothyroidism
* Osteoporosis
* Renal impairment
* Hepatic impairment and Coagulation disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual analogue pain scale
Timeframe: baseline then every 3 months until one year after randomisation