Surgical Treatments for Postamputation Pain
Residual Limb Pain, Amputation Neuroma, Phantom Limb Pain
About this trial
This is an interventional treatment trial for Residual Limb Pain
Eligibility Criteria
Inclusion Criteria:
- The participant must have a major limb amputation.
- The participant is ≥ 18 years old at the time of consent.
- The participant must be in generally good health to undergo a surgical treatment, as per the clinical investigator's opinion.
- The post-operative amputation follow-up is greater than one year at time of consent.
- The participant must be diagnosed with neuroma pain, stump pain, or phantom limb in their residual limb, at latest the time of screening visit.
- The participant must have an average pain score (of neuroma pain, sump pain or PLP) greater than three on the Numerical Rating Scale (NRS, 0-10) after the baseline period.
- If the participant is prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least one month before the screening visit.
- If the participant is prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation or mirror therapy, the treatment must have ended at least one month before the screening visit.
- The participant has sufficient understanding of Swedish or English to be able to participate in all study assessments, as per the principal investigator's opinion.
Exclusion Criteria:
- Neurological or other conditions that affect nerve regeneration.
- Active infection in the residual limb.
- Smokers or less than six weeks of smoking cessation at inclusion.
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation, as per the principal investigator's discretion.
- Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.
Sites / Locations
- Northwestern Memorial Hospital
- Massachusetts General Hospital
- University of Michigan Health System
- Dandenong Hospital, Monash Health
- University of Alberta Hospital
- Worker Hospital
- Rizzoli Orthopedic Institute
- Sahlgrenska University HospitalRecruiting
- NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Targeted Muscle Reinnervation (TMR)
Regenerative Peripheral Nerve Interface (RPNI)
Standard neuroma treatment, neuroma excision, and muscle burying
The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.
The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.
The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.