Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284583
Status:
UNKNOWN
Last Update Posted:
2006-02-01
First Post:
2006-01-30
Brief Title:
Comparison of Alcohol and Steroid Injection for Treating Mortons Neuroma
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Mortons Neuroma
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 groups 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 Mortons neuroma symptoms
120 patients from one Orthopaedic groups 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 Mortons neuroma symptoms
Detailed Description:
Interdigital neuroma or Mortons 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 TG 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 Gauthiers 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 ligament36 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 neuroma3
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 injections8 Persistent symptoms ultimately require surgical excision or division of the transverse metatarsal ligament both of which have good long term outcomes in literature27
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 Mortons 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 Mortons 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
Current understanding of interdigital neuroma is based on Gauthiers 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 ligament36 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 neuroma3
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 injections8 Persistent symptoms ultimately require surgical excision or division of the transverse metatarsal ligament both of which have good long term outcomes in literature27
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 Mortons 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 Mortons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None