Morton's Neuroma: Manipulation Versus Steroid Injection

January 29, 2023 updated by: Dundee Podiatry Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH3 9AU
        • Podiatry Department NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue pain scale
Time Frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
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
Time Frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot function index questionnaire
Time Frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
A questionnaire to establish subjects level of function, pain and mobility changes over time
pre treatment at each clinic visit and then 3,6,9 and 12 months
Manchester Oxford Foot Pain Questionnaire
Time Frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
Patient reported outcome measurement tool to measure changes in foot pain over time
pre treatment at each clinic visit and then 3,6,9 and 12 months
Short Form 36 pain and disability Questionnaire
Time Frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
A quality of life questionnaire
pre treatment at each clinic visit and then 3,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dundee Podiatry Clinic

Collaborators

Queen Margaret University

Investigators

  • Principal Investigator: David G Cashley, BSc(Hons)Pod, Queen Margaret University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDN001
  • 129586 (REGISTRY: Integrated Reasearch Application System)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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