Surgical Treatments for Postamputation Pain
NCT05009394 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-01-09
Summary
This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.
Conditions
- Residual Limb Pain
- Amputation Neuroma
- Phantom Limb Pain
- Pain, Neuropathic
- Pain, Nerve
Interventions
- PROCEDURE
-
Targeted Muscle Reinnervation (TMR)
Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
- PROCEDURE
-
Regenerative Peripheral Nerve Interface (RPNI)
Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
- PROCEDURE
-
Standard neuroma treatment, neuroma excision, and muscle burying
Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.
Sponsors & Collaborators
-
Vastra Gotaland Region
collaborator OTHER_GOV -
Göteborg University
collaborator OTHER -
Istituto Ortopedico Rizzoli
collaborator OTHER -
Hospital del Trabajador de Santiago
collaborator OTHER -
NHS Lothian
collaborator OTHER_GOV -
NHS Greater Clyde and Glasgow
collaborator OTHER -
NHS Grampian
collaborator OTHER_GOV -
Northwestern Memorial Hospital
collaborator OTHER - collaborator OTHER
-
Massachusetts General Hospital
collaborator OTHER -
Dandenong Hospital
collaborator UNKNOWN -
University of Alberta
collaborator OTHER -
Prometei Pain Rehabilitation Center
lead OTHER
Principal Investigators
-
Max Ortiz Catalan, PhD · Prometei Pain Rehabilitation Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-20
- Primary Completion
- 2026-06-30
- Completion
- 2029-06-30
Countries
- United States
- Australia
- Canada
- Chile
- Italy
- Sweden
- United Kingdom
Study Locations
More Related Trials
-
Postamputation Pain: Peripheral Mechanisms
NCT03317600 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above-Knee Amputees
NCT00686764 ·Status: COMPLETED
-
Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction
NCT02440542 ·Status: WITHDRAWN
-
Leg Amputation and Continuous Sciatic Nerve Block
NCT00427947 ·Status: TERMINATED ·Phase: PHASE3
-
Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
NCT00768248 ·Status: TERMINATED ·Phase: NA
-
Pain in Trans Femoral and Trans Tibial Amputees
NCT03789435 ·Status: COMPLETED
-
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
NCT00443404 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
NCT03051113 ·Status: COMPLETED
-
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
NCT01824082 ·Status: COMPLETED ·Phase: PHASE4
-
Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain
NCT05608733 ·Status: UNKNOWN ·Phase: PHASE3
-
A Trial of Lidocaine Patch for Lower Limb Amputation Pain
NCT02696720 ·Status: WITHDRAWN ·Phase: PHASE2
-
Electrical Nerve Block for Amputation Pain
NCT02221934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Pain in Amputees Reduced by Administration of Diet Examination
NCT05460845 ·Status: COMPLETED ·Phase: NA
-
Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation
NCT06693427 ·Status: COMPLETED
-
Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain
NCT07102654 ·Status: NOT_YET_RECRUITING
-
Cryolesion in Treatment of Phantom Limb Pain
NCT03415360 ·Status: UNKNOWN ·Phase: NA
-
Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
NCT03461120 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
NCT06071715 ·Status: COMPLETED ·Phase: NA
-
Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT
NCT06964347 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
NCT05320913 ·Status: UNKNOWN ·Phase: NA
-
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain
NCT03255395 ·Status: UNKNOWN ·Phase: NA
-
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
NCT01748435 ·Status: UNKNOWN
-
C-RFA of Residual Limb Neuroma
NCT04538417 ·Status: COMPLETED ·Phase: NA
-
Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement
NCT01470391 ·Status: COMPLETED ·Phase: NA
-
Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain
NCT05046639 ·Status: TERMINATED ·Phase: PHASE4