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Morton's NeuromaNCT00284583

Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma

A study testing Injection of Steroid into Foot, Injection of Alcohol into Foot and Injection of Lidocaine into Foot in people with Morton's Neuroma, run by Brown University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe paresthesias thought to result from entrapment of the interdigital nerve by the overlying transverse metatarsal ligament. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Morton's Neuroma
What is being tested?
Injection of Steroid into Foot, Injection of Alcohol into Foot and Injection of Lidocaine into Foot
Type of treatment
Injection or infusion
How many people
120 participants
Where
1 siteUnited States
Study dates
May 2005to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 2 months of 2 or more of the following
  • Plantar pain increased by walking localized to the 2nd and 3rd interspaces
  • Relief of pain by resting
  • Pain radiating into toes
  • Numbness in toes or foot
  • Cramping in toes and foot
Show all 12Show fewer
  • 2 or More of the Following physical Findings
  • Plantar tenderness
  • Radiation of elicited pain into the toes
  • Palpable plantar mass
  • Numbness in toes
  • Exacerbation of symptoms with Mulder's maneuver

Who cannot join

  • Past treatment for Morton's neuroma or had prior foot surgery.
  • Concurrent conditions such as hallux valgus, metatarsalgia, lesser toe abnormalities, atraumatic synovitis of metatarsophalangeal joint and other foot and ankle based nerve compression neuropathies.
  • Further, patients with neuroma symptoms in the 1st and 4th interspaces.

Trial locations and contacts

1 site in 1 country.

Mark C Lee, MD contact

401-350-6432

marklee007@gmail.com

United States1 site, 1 recruiting
  • Rhode Island Hospital Orthopaedic Clinic

    Providence, Rhode Island, 02908

    Mark C Lee, MD

    Christopher Digiovanni, MD

    Recruiting

Other trials in United States

About this study

Official title: Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma

Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe paresthesias thought to result from entrapment of the interdigital nerve by the overlying transverse metatarsal ligament. Multiple treatments have been recommended for this condition and range from modification of shoe wear to surgical excision of the painful nerve. Serial ethanol injection therapy has been reported to be an effective alternative to surgical excision. However, despite wide adoption of this treatment, no randomized, double blinded, placebo-controlled study exists to verify the efficacy of this treatment in comparison to longer standing similar therapies, such as corticosteroid injection.

120 patients from one Orthopaedic group's foot and ankle offices with single foot neuromas and no previous history of neuroma or foot disorder treatment will be selected for the study. These patients will be randomized to three treatments, specifically lidocaine injection, corticosteroid injection, or ethanol injection. Outcomes will be assessed at 3, 6 and 12 month time points using validated questionnaires as well as a non-validated disease specific questionnaire. Primary endpoint will be graded change in the physical function portion of the SF-36 form. Secondary endpoints will be the graded change in the McGill Short Form for Pain and ultimate satisfaction with treatment as assessed by a non-validated questionnaire designed for Morton's neuroma symptoms.

Read the detailed description

Interdigital neuroma, or Morton's Neuroma, is a painful forefoot disorder characterized by plantar pain and paresthesias radiating to toes. The condition was first described in 1845 by Lewis Durlacher as a painful "neuralgic affection" of the plantar nerve between the third and fourth metatarsals. T.G. Morton, in 1876, attributed the painful symptom complex to a "neuroma." His observation was confirmed by Hoadley who, in 1893, performed a curative excision of a "neuroma" between the third and fourth metatarsals.

Current understanding of interdigital neuroma is based on Gauthier's conclusion in 1979 that the symptom complex was a result of an entrapment neuropathy of the interdigital nerve by the overlying transverse metatarsal ligament. Presently, no definitive single etiology has been confirmed. Additional potential pathoetiologies include the aberrant anatomy of the plantar nerve in this location, trauma and extrinsic mass effect above or below the level of the transverse metatarsal ligament.(3,6) The histological appearance of the affected nerve, however, is consistent and suggests that "neuroma" is a misnomer for this condition. The nerve tissue demonstrates demyelination and deposition of amorphous eosinophilic material, but no exuberant proliferation of nerve endings characteristic of neuroma.(3)

Multiple treatments have been recommended for the management of interdigital neuroma. The usual algorithm begins with an attempt at conservative therapy consisting of shoe wear modifications and the application of a metatarsal pad. Failure of conservative management may prompt a trial of corticosteroid injections.(8) Persistent symptoms ultimately require surgical excision or division of the transverse metatarsal ligament, both of which have good long term outcomes in literature.(2,7)

Recently, serial ethanol injection therapy has been reported to be an effective alternative to surgical excision and has been widely adopted in the treatment of Morton's neuroma. Dockery et. al. reported 89% success rate in a series of 100 consecutive patients treated with 3 to 7 injections of 4% ethanol solutions with an average follow-up of 13 months. Fanucci and Masala reported a 90% success rate at 10 month follow-up after 3 to 7 injections of 30% alcohol in a consecutive series of 40 patients. However, none of these studies were performed in a randomized, double blinded fashion with adequate controls. Therefore, no scientifically valid conclusions concerning treatment efficacy can be made.

The proposed study investigates alcohol sclerosing therapy for the treatment of Morton's neuroma in a randomized, double-blinded, placebo-controlled clinical trial. The primary end point will be evaluation of patient physical function according to the standardized SF-36 questionnaire after the treatment period. Secondary end points include evaluation of pain and satisfaction levels after treatment using, respectively, a standardized and a novel questionnaire.

Being tested
Injection of Steroid into Foot, Injection of Alcohol into Foot, Injection of Lidocaine into Foot
Keywords
Morton's Neuroma, Alcohol, Steroid
Medical subject headings
Morton Neuroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of Steroid into FootDrug

  • Injection of Alcohol into FootDrug

  • Injection of Lidocaine into FootDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Pain Scale

  2. 2. Physical function scale.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2006 (estimated)
  2. Study startMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00284583
Sponsor's protocol ID
0061-05
Status last verified
Jan 2006
First submitted
30 Jan 2006
Last updated
1 Feb 2006
Results posted
No

Publications

  • Bennett GL, Graham CE, Mauldin DM. Morton's interdigital neuroma: a comprehensive treatment protocol. Foot Ankle Int. 1995 Dec;16(12):760-3. doi: 10.1177/107110079501601204.

    PubMed 8749346
  • Bradley N, Miller WA, Evans JP. Plantar neuroma: analysis of results following surgical excision in 145 patients. South Med J. 1976 Jul;69(7):853-4.

    PubMed 941051
  • Dockery GL. The treatment of intermetatarsal neuromas with 4% alcohol sclerosing injections. J Foot Ankle Surg. 1999 Nov-Dec;38(6):403-8. doi: 10.1016/s1067-2516(99)80040-4.

    PubMed 10614611
  • Fanucci E, Masala S, Fabiano S, Perugia D, Squillaci E, Varrucciu V, Simonetti G. Treatment of intermetatarsal Morton's neuroma with alcohol injection under US guide: 10-month follow-up. Eur Radiol. 2004 Mar;14(3):514-8. doi: 10.1007/s00330-003-2057-7. Epub 2003 Oct 3.

    PubMed 14531002

Questions about this trial

What is this clinical trial studying?

A study testing Injection of Steroid into Foot, Injection of Alcohol into Foot and Injection of Lidocaine into Foot in people with Morton's Neuroma, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mark C Lee, MD (401-350-6432, marklee007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Pain Scale. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00284583, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2006.

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