Simple Neurectomy Versus Neurectomy with Intramuscular Implantation for Interdigital Neuroma: A randomized controlled trial

Phase 2

Recruiting

• Conditions: Interdigital neuritis; Morton Neuroma

• Registration Number: TCTR20240724001
• Lead Sponsor: Phramongkutklao Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-24
• Last Update Posted: 19 August 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 20 years or older., 2. Able to communicate in Thai or English., 3. Diagnosed with interdigital neuritis in a single web space based on tenderness location and/or Mulder's click during physical examination, MRI findings, and/or positive diagnostic injection at the affected web space., 4.No response to conservative treatment for at least 6 months.

Exclusion Criteria

1. History of previous surgery for interdigital neuroma/neuritis., 2.Presence of multiple interdigital neuromas in the same foot.
History of previous forefoot surgery.,3.Diagnosis of polyneuropathy.4.Poorly controlled diabetes mellitus with neuropathy.,5.Established proximal nerve root pathology (e.g., lumbar radiculopathy).6.Presence of another neoplasm in the same web space.7.Metatarsalgia of undetermined cause.8.Inability to comprehend or communicate about the study protocol and treatment due to physical or mental reasons.9.Pregnancy.10.Patients with other contraindications to surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain (Metatarsalgia) at 12 months after intervention pain visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Foot function at 12 months after intervention Foot and ankle ability measure (FAAM) score,Quality of life at 12 months after intervention SF-36