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Morton's Neuroma: Manipulation Versus Steroid Injection

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ClinicalTrials.gov Identifier: NCT02304094
Recruitment Status : Unknown
Verified March 2016 by David Cashley, Queen Margaret University.
Recruitment status was:  Recruiting
First Posted : December 1, 2014
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
David Cashley, Queen Margaret University

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.


Condition or disease Intervention/treatment Phase
Neuroma, Human Forefoot Drug: methylprednisolone Other: Manual manipulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: manipulation
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
the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique

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




Primary Outcome Measures :
  1. Visual analogue pain scale [ Time Frame: baseline then every 3 months until one year after randomisation ]
    Assessing change from baseline to one year in recorded visual analogue pain scales


Secondary Outcome Measures :
  1. Algometric pressure threshold testing [ Time Frame: every 3 months until one year after randomisation ]
    Assessing change from baseline to one year in recorded Algometric pressure threshold scores

  2. Manchester - Oxford Foot Questionnaire [ Time Frame: every 3 months until one year after randomisation ]
    Assessing change from baseline to one year in recorded Manchester - Oxford Foot Questionnaire scores

  3. The Foot and Ankle Ability Measure [ Time Frame: every 3 months until one year after randomisation ]
    Assessing change from baseline to one year in recorded The Foot and Ankle Ability Measurements

  4. SF-36 Questionnaire [ Time Frame: every 3 months until one year after randomisation ]
    Assessing change from baseline to one year in recorded SF-36 Questionnaire scores



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria shall be any positive clinical sign together with a positive diagnostic ultrasound giving rise to a diagnosis of Morton's neuroma/plantar digital neuritis.
  • 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.

Exclusion Criteria:

  • Absolute exclusion criteria will include Rheumatoid Arthritis, recent (less than 3 months) fracture to the affected foot, peripheral neuropathy, localised infection, pregnancy, allergy to Methylprednisolone.
  • Allergy to local anaesthetic.
  • Further exclusion criteria include Active infection
  • Diabetes mellitus
  • Ulcerative colitis
  • Diverticulitis
  • Hypothyroidism
  • Osteoporosis
  • Renal impairment
  • Hepatic impairment and Coagulation disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304094


Contacts
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Contact: David Cashley, BSc (Hons) 441314740000 DCashley@qmu.ac.uk

Locations
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United Kingdom
Queen Margaret University Recruiting
Musselburgh, Lothian, United Kingdom, EH21 6UU
Sponsors and Collaborators
Queen Margaret University
Investigators
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Study Director: Derek Santos, PhD Queen Margaret University

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Responsible Party: David Cashley, Mr David Cashley, Queen Margaret University
ClinicalTrials.gov Identifier: NCT02304094     History of Changes
Other Study ID Numbers: PDN001
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Neuroma
Morton Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents