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Morton's Neuroma: Manipulation Versus Steroid Injection

NCT02304094 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-03-29

No results posted yet for this study

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.

Conditions

  • Neuroma, Human Forefoot

Interventions

DRUG

methylprednisolone

the steroid group shall receive a single injection of 1 mL methylprednisolone \[40 mg\] and 1 mL 2% lignocaine

OTHER

Manual manipulation

the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique

Sponsors & Collaborators

  • Queen Margaret University

    lead OTHER

Principal Investigators

  • Derek Santos, PhD · Queen Margaret University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2017-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304094 on ClinicalTrials.gov