Morton's Neuroma: Manipulation Versus Steroid Injection

Study Overview
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Brief Summary
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This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.

Detailed Description
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The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection 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.

Official Title
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Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma

Conditions
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Morton Neuroma

Intervention / Treatment
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* Drug: methylprednisolone
* Procedure: manual manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of morton's neuroma over 18 years of age presenting VAS score > 30mm Exclusion Criteria: diabetes, rheumatoid arthritis fibromyalgia. Those currently taking Statins or analgesics previous neuroma surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: steroid injection<br>1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine | Drug: methylprednisolone<br>* a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine<br>* Other names: Depo-Medrone with Lidocaine (40mg + 10mg)/ml;|
| Experimental: manual manipulation<br>weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks | Procedure: manual manipulation<br>* The lesser MTPJs of the affected foot will be manually manipulated using a high velocity, low amplitude thrust technique.<br>* Other names: adjustment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain scale | Measuring changes in self reported pain over time. 100mm scale with anchored prompts of no pain at 0mm and worst pain ever at 100mm | pre treatment at each clinic visit and then 3,6,9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algometric pressure threshold meter | Measuring changes in pressure tolerance over time. A meter which reads how much change in pressure a joint can withstand before it registers discomfort | pre treatment at each clinic visit and then 3,6,9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manipulation, plantar digital neuritis, morton's neuroma, nerve entrapment, foot