Morton's Neuroma: Manipulation Versus Steroid Injection

NCT ID: NCT05707572

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Morton Neuroma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

steroid injection

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

Group Type: ACTIVE_COMPARATOR

methylprednisolone

Intervention Type: DRUG

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

manual manipulation

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

Group Type: EXPERIMENTAL

manual manipulation

Intervention Type: PROCEDURE

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

Interventions

methylprednisolone

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

Intervention Type: DRUG

manual manipulation

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

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Margaret University

OTHER

Sponsor Role: collaborator

Dundee Podiatry Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David G Cashley, BSc(Hons)Pod

Role: PRINCIPAL_INVESTIGATOR

Queen Margaret University

Locations

Podiatry Department NHS Lothian

Edinburgh, Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

129586

Identifier Type: REGISTRY

Identifier Source: secondary_id

PDN001

Identifier Type: -

Identifier Source: org_study_id