Skip to main content
OpenTrials
Completed

NCT Number: NCT05707572

Morton's Neuroma: Manipulation Versus Steroid Injection

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morton Neuroma Foot Diseases Joint Diseases Metatarsalgia Musculoskeletal Diseases Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Podiatry Department NHS Lothian

Edinburgh, Lothian, EH3 9AU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

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

manual manipulation

Procedure

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

Other names: adjustment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Dundee Podiatry Clinic

Other

Collaborators

  • Queen Margaret University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.