Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.
John T Farrar, James P Young, Linda LaMoreaux...
https://pubmed.ncbi.nlm.nih.gov/11690728Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06719245
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Lower Extremity Amputations
Led by Leiden University Medical Center · Updated on 2025-09-19
203
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
A
Alrijne Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating postamputation pain, including phantom limb pain and residual limb pain, in patients who have undergone lower extremity amputation due to vascular disease. The study compares standard nerve handling (neurectomy) with Targeted Muscle Reinnervation (TMR), a surgical technique aimed at preventing neuroma formation by rerouting cut nerve ends to motor nerves. This national, multicenter, randomized, sham-controlled trial aims to assess if TMR improves pain outcomes, quality of life, social participation, and reduces health-related costs. Participants aged 18 to 75 years undergoing transfemoral to transtibial amputation are randomly assigned to either standard neurectomy or TMR. Standard neurectomy involves cutting nerves with or without traction, coagulation, or local anesthetic infiltration but without nerve ligation. TMR involves identifying transected nerves, dissecting them proximally, stimulating motor nerve branches, and coapting amputated nerves end-to-end to motor branches. For upper leg amputations, an additional superficial incision is made in both groups to maintain blinding. The procedure extends surgery time by 30 to 90 minutes. Participants will complete multiple online questionnaires at five time points postoperatively: 2 weeks, and 3, 6, 9, and 12 months. Researchers will measure pain intensity using numerical rating scales and patient-reported pain behavior and interference. Secondary outcomes include neuropathic pain, anxiety, depression, prosthetic rehabilitation, quality of life, and healthcare costs. The study will monitor safety, surgical complications, and overall patient burden, with minimal risk anticipated from the additional procedure and follow-up lasting one year.
CONDITIONS
Brief Title
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years old
- Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease
You will not qualify if you...
- Insensate limbs at the level of amputation
- Complex Regional Pain Syndrome
- Existing neuroma or prior neuroma surgery in the affected limb
- Undergoing radiotherapy on the affected limb
- Cognitive impairment or delirium at the time of consent
- Patients unfit for general anesthesia
- No nerve surgeon trained in the TMR procedure is available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo lower extremity amputation surgery with either standard neurectomy or targeted muscle reinnervation (TMR) as part of the study intervention.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants complete multiple online questionnaires and pain diaries to monitor pain and recovery over one year after surgery.
5 online questionnaire assessments at 2 weeks, 3, 6, 9, and 12 months
Trial Site Locations
Total: 7 locations
1
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Not Yet Recruiting
2
Isala Zwolle
Zwolle, Overijssel, Netherlands, 8025 AB
Not Yet Recruiting
3
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
4
Alrijne Zorggroep
Leiderdorp, South Holland, Netherlands, 2353 GA
Not Yet Recruiting
5
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
6
Haaglanden Medisch Centrum
The Hague, South Holland, Netherlands, 2512 VA
Not Yet Recruiting
7
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
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Research Team
J
Justus L Groen, Md PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees.
Lauren M Mioton, Gregory A Dumanian, Nikita Shah...
https://pubmed.ncbi.nlm.nih.gov/32452928Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?
Rafael Dal-Ré, Perrine Janiaud, John P A Ioannidis
https://pubmed.ncbi.nlm.nih.gov/29615035Estimating the burden of disease in chronic pain with and without neuropathic characteristics: does the choice between the EQ-5D and SF-6D matter?
Nicola Torrance, Kenny D Lawson, Ebenezer Afolabi...
https://pubmed.ncbi.nlm.nih.gov/25020004Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States.
Bruce Parsons, Caroline Schaefer, Rachael Mann...
https://pubmed.ncbi.nlm.nih.gov/23825931Genetic and phenotypic heterogeneity in sporadic and familial forms of paroxysmal dyskinesia.
Alexander J A Groffen, Thom Klapwijk, Anne-Fleur van Rootselaar...
https://pubmed.ncbi.nlm.nih.gov/22752065Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation.
Ian L Valerio, Gregory A Dumanian, Sumanas W Jordan...
https://pubmed.ncbi.nlm.nih.gov/30634038Targeted Muscle Reinnervation at the Time of Major Limb Amputation in Traumatic Amputees: Early Experience of an Effective Treatment Strategy to Improve Pain.
Travis L Frantz, Joshua S Everhart, Julie M West...
https://pubmed.ncbi.nlm.nih.gov/33123667Predictive value of a diagnostic block in focal nerve injury with neuropathic pain when surgery is considered.
Martijn J A Malessy, Ralph de Boer, Ildefonso Muñoz Romero...
https://pubmed.ncbi.nlm.nih.gov/30208078Targeted Muscle Reinnervation Does Not Increase the Risk of Postsurgical Complication or Overall Cost.
Sorka T Deeyor, Haroon M Kisana, Clayton H Hui...
https://pubmed.ncbi.nlm.nih.gov/36032374