Morton's Neuroma: Manipulation Versus Steroid Injection

Sponsor

Dundee Podiatry Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT05707572

Collaborator

Queen Margaret University (Other)

Enrollment

Location

Arms

60.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Morton Neuroma	Drug: methylprednisolone Procedure: manual manipulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual analogue pain scale [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 Outcome Measures

Algometric pressure threshold meter [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 Outcome Measures

Foot function index questionnaire [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
Manchester Oxford Foot Pain Questionnaire [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
Short Form 36 pain and disability Questionnaire [pre treatment at each clinic visit and then 3,6,9 and 12 months]
A quality of life questionnaire