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Morton's Neuroma: Manipulation Versus Steroid Injection

Primary Purpose

Morton Neuroma

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

methylprednisolone

manual manipulation

About this trial

This is an interventional treatment trial for Morton Neuroma focused on measuring manipulation, plantar digital neuritis, morton's neuroma, nerve entrapment, foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Podiatry Department NHS Lothian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

steroid injection

manual manipulation

Arm Description

1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine

weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05707572

First Posted

July 24, 2018

Last Updated

January 29, 2023

Sponsor

Dundee Podiatry Clinic

Collaborators

Queen Margaret University

1. Study Identification

Unique Protocol Identification Number

NCT05707572

Brief Title

Morton's Neuroma: Manipulation Versus Steroid Injection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

September 2014 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dundee Podiatry Clinic

Collaborators

Queen Margaret University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morton Neuroma

Keywords

manipulation, plantar digital neuritis, morton's neuroma, nerve entrapment, foot

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

steroid injection

Arm Type

Active Comparator

Arm Description

1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine

Arm Title

manual manipulation

Arm Type

Experimental

Arm Description

weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Other Intervention Name(s)

Depo-Medrone with Lidocaine (40mg + 10mg)/ml

Intervention Description

a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine

Intervention Type

Procedure

Intervention Name(s)

manual manipulation

Other Intervention Name(s)

adjustment

Intervention Description

The lesser MTPJs of the affected foot will be manually manipulated using a high velocity, low amplitude thrust technique.

Primary Outcome Measure Information:

Title

Visual analogue pain scale

Description

Measuring changes in self reported pain over time. 100mm scale with anchored prompts of "no pain" at 0mm and "worst pain ever" at 100mm

Time Frame

pre treatment at each clinic visit and then 3,6,9 and 12 months

Secondary Outcome Measure Information:

Title

Algometric pressure threshold meter

Description

Measuring changes in pressure tolerance over time. A meter which reads how much change in pressure a joint can withstand before it registers discomfort

Time Frame

pre treatment at each clinic visit and then 3,6,9 and 12 months

Other Pre-specified Outcome Measures:

Title

Foot function index questionnaire

Description

A questionnaire to establish subjects level of function, pain and mobility changes over time

Time Frame

pre treatment at each clinic visit and then 3,6,9 and 12 months

Title

Manchester Oxford Foot Pain Questionnaire

Description

Patient reported outcome measurement tool to measure changes in foot pain over time

Time Frame

pre treatment at each clinic visit and then 3,6,9 and 12 months

Title

Short Form 36 pain and disability Questionnaire

Description

A quality of life questionnaire

Time Frame

pre treatment at each clinic visit and then 3,6,9 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David G Cashley, BSc(Hons)Pod

Organizational Affiliation

Queen Margaret University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Podiatry Department NHS Lothian

City

Edinburgh

State/Province

Lothian

ZIP/Postal Code

EH3 9AU

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Morton's Neuroma: Manipulation Versus Steroid Injection

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