Morton's Neuroma: Manipulation Versus Steroid Injection

Morton Neuroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707572
• Other study ID #: PDN001
• Secondary ID: 129586
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2023
• Source: Dundee Podiatry Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

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

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

Locations

Country	Name	City	State
United Kingdom	Podiatry Department NHS Lothian	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
Dundee Podiatry Clinic	Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot function index questionnaire	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
Other	Manchester Oxford Foot Pain Questionnaire	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
Other	Short Form 36 pain and disability Questionnaire	A quality of life questionnaire	pre treatment at each clinic visit and then 3,6,9 and 12 months
Primary	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	pre treatment at each clinic visit and then 3,6,9 and 12 months
Secondary	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	pre treatment at each clinic visit and then 3,6,9 and 12 months