Morton's Neuroma: Manipulation Versus Steroid Injection

NCT05707572 | Completed

• 2 other identifiers: PDN001129586
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morton Neuroma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Algometric pressure threshold meter

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

Other Outcomes (3)

• Foot function index questionnaire

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

• Manchester Oxford Foot Pain Questionnaire

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

• Short Form 36 pain and disability Questionnaire

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

Study Arms (2)

steroid injection

ACTIVE COMPARATOR

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

Drug: methylprednisolone

manual manipulation

EXPERIMENTAL

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

Procedure: manual manipulation

Interventions

methylprednisolone DRUG

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

Also known as: Depo-Medrone with Lidocaine (40mg + 10mg)/ml

steroid injection

manual manipulation PROCEDURE

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

Also known as: adjustment

manual manipulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of morton's neuroma
• over 18 years of age
• presenting VAS score \> 30mm

You may not qualify if:

• diabetes,
• rheumatoid arthritis
• fibromyalgia.
• Those currently taking Statins or analgesics
• previous neuroma surgery

Sponsors & Collaborators

• Dundee Podiatry Clinic: lead
• Queen Margaret University: collaborator

Study Sites (1)

Podiatry Department NHS Lothian

Edinburgh, Lothian, EH3 9AU, United Kingdom

Location

MeSH Terms

Conditions

Morton Neuroma; Nerve Compression Syndromes

Interventions

Methylprednisolone; Methylprednisolone Acetate; Lidocaine; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• David G Cashley, BSc(Hons)Pod

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: February 1, 2023
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 30, 2019
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

GB (1)