Morton's Neuroma: Manipulation Versus Steroid Injection

NCT02304094 | Unknown DMC

• 1 other identifier: PDN001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to establish which of two treatment options is the preferred intervention in the treatment of Morton's Neuroma. A randomised controlled trial shall be performed. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, manipulation shall be compared to a control group receiving a steroid injection in an equality randomised controlled trial. Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS of 20mm above the other 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. There is limited research evidence to support the management of Morton's neuroma with steroid injection although its efficacy has only been demonstrated in the short term.

Conditions

Neuroma, Human Forefoot

Outcome Measures

Primary Outcomes (1)

• Visual analogue pain scale

  Assessing change from baseline to one year in recorded visual analogue pain scales

  baseline then every 3 months until one year after randomisation

Secondary Outcomes (4)

• Algometric pressure threshold testing

  every 3 months until one year after randomisation

• Manchester - Oxford Foot Questionnaire

  every 3 months until one year after randomisation

• The Foot and Ankle Ability Measure

  every 3 months until one year after randomisation

• SF-36 Questionnaire

  every 3 months until one year after randomisation

Study Arms (2)

manipulation

EXPERIMENTAL

Those in the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique. They will be asked to return once each week for a further five weeks. At each visit the VAS and PTM measurements shall be repeated, as will the manual manipulation. They shall also be asked to return for a review in the sixth week.

Other: Manual manipulation

Steroid

ACTIVE COMPARATOR

Those randomised to the steroid group shall receive a single injection of 1 mL methylprednisolone \[40 mg\] and 1 mL 2% lignocaine. They shall then be asked to return for review in six weeks. A second injection may be offered at this point if clinically indicated.

Drug: methylprednisolone

Interventions

methylprednisolone DRUG

the steroid group shall receive a single injection of 1 mL methylprednisolone \[40 mg\] and 1 mL 2% lignocaine

Steroid

Manual manipulation OTHER

the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique

manipulation

Eligibility Criteria

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

You may qualify if:

• A VAS score of no less than 25/100 will also be required.
• All subjects must be over 18 years of age and able to offer informed consent.

You may not qualify if:

• Allergy to local anaesthetic.
• Diabetes mellitus
• Ulcerative colitis
• Diverticulitis
• Hypothyroidism
• Osteoporosis
• Renal impairment
• Hepatic impairment and Coagulation disorders.

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Queen Margaret University

Musselburgh, Lothian, EH21 6UU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuroma

Interventions

Methylprednisolone; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Derek Santos, PhD

  Queen Margaret University

  STUDY DIRECTOR

Central Study Contacts

David Cashley, BSc (Hons)

CONTACT

441314740000; DCashley@qmu.ac.uk

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: PRINCIPAL INVESTIGATOR
• PI Title: Mr David Cashley

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 1, 2014
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

GB (1)