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.
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.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital Orthopaedic Clinic
Providence, Rhode Island, 02908
Mark C Lee, MD
Christopher Digiovanni, MD
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.
- Conditions
- Morton's Neuroma
- 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. Pain Scale
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.
- First posted1 Feb 2006 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Morton's NeuromaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Digiovanni, MD, Principal investigator, Rhode Island Hospital, Brown Medical School
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 8749346Bradley 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 941051Dockery 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 10614611Fanucci 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma
- ClinicalTrials.gov ID
- NCT00284583
- Acronym / sponsor ID
- 0061-05
- Conditions
- Morton's Neuroma
- Keywords
- Morton's Neuroma, Alcohol, Steroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- May 2005
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of Steroid into Foot | Drug | – |
| Injection of Alcohol into Foot | Drug | – |
| Injection of Lidocaine into Foot | Drug | – |
Primary outcome
1. Pain Scale
2. Physical function scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2006.
- Background: PubMed 8749346Bennett 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.
- Background: PubMed 941051Bradley 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.
- Background: PubMed 10614611Dockery 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.
- Background: PubMed 14531002Fanucci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Digiovanni, MD principal investigator
Rhode Island Hospital, Brown Medical School
1 site in 1 country: see every site and its status.
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.