Abstract
Objective:To compare targeted muscle reinnervation (TMR) to "standard treatment" of neuroma excision and burying into muscle for postamputation pain.Summary Background Data:To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain.Methods:A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre- and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function.Results:In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus -0.2 (difference 3.4, adjusted confidence interval (aCI) -0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI -0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment.Conclusions:In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy.Trial Registration:NCT 02205385 at ClinicalTrials.gov.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 238-246 |
| Number of pages | 9 |
| Journal | Annals of surgery |
| Volume | 270 |
| Issue number | 2 |
| DOIs | |
| State | Published - Aug 1 2019 |
Keywords
- neuroma
- phantom limb pain
- postamputation pain
- randomized clinical trial
- targeted muscle reinnervation
ASJC Scopus subject areas
- Surgery
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In: Annals of surgery, Vol. 270, No. 2, 01.08.2019, p. 238-246.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees
T2 - A Randomized Clinical Trial
AU - Dumanian, Gregory A.
AU - Potter, Benjamin K.
AU - Mioton, Lauren M.
AU - Ko, Jason H.
AU - Cheesborough, Jennifer E.
AU - Souza, Jason M.
AU - Ertl, William J.
AU - Tintle, Scott M.
AU - Nanos, George P.
AU - Valerio, Ian L.
AU - Kuiken, Todd A.
AU - Apkarian, A. Vania
AU - Porter, Kyle
AU - Jordan, Sumanas W.
N1 - Funding Information: Objective: To compare targeted muscle reinnervation (TMR) to ‘‘standard treatment’’ of neuroma excision and burying into muscle for postamputation pain. Summary Background Data: To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain. Methods: A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre-and postoperative numerical rating scale (NRS, 0–10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function. Results: In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus −0.2 (difference 3.4, adjusted confidence interval (aCI) −0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI −0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference From the *Division of Plastic Surgery, Northwestern Feinberg School of Medicine, Chicago, IL; †Division of Plastic Surgery and Orthopaedic Surgery Service, Department of Surgery, Uniformed Services University–Walter Reed National Military Medical Center, Bethesda, MD; zDepartment of Orthopedic Surgery, University of Oklahoma, Norman, OK; §Department of Plastic Surgery, The Ohio State University, Columbus, OH; ôDepartment of Physiology, Northwestern Feinberg School of Medicine, Chicago, IL; and ||Center for Biostatistics, The Ohio State University, Columbus, OH. GAD and BKP contributed equally to the execution of this randomized control study and the development of this manuscript (co-first authors). This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH-13-2-0100. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Also this work was supported by the Frankel Foundation for the study and treatment of amputees. Treatment of amputees for neuroma pain was registered trial NCT 02205385 at ClinicalTrials.gov. Author contributions: Gregory A. Dumanian, MD, made substantial contributions to conception and design, acquisition of data, and interpretation of data, participated in drafting the article and revising it critically for important intellectual content, and gave final approval of the version to be published. Benjamin K. Potter, MD, made substantial contributions to conception and design, acquisition of data, and interpretation of data, participated in drafting the article and revising it critically for important intellectual content, and gave final approval of the version to be published. Lauren M. Mioton, MD, made substantial contributions to conception and design, acquisition of data, analysis and interpretation of data, participated in drafting the article and revising it critically for important intellectual content, and gave final approval of the version to be published. Jason H. Ko, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Jennifer E. Cheesborough, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Jason M. Souza, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. William J. Ertl, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Scott M. Tintle, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. George P. Nanos, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Ian L. Valerio, MD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Todd A Kuiken, MD, PhD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. A. Vania Apkarian, PhD, made substantial contributions to conception and design, interpretation of data, participated in revising the article critically for important intellectual content, and gave final approval of the version to be published. Kyle Porter, MAS, made substantial contributions to conception and design, analysis and interpretation of data, participated in drafting the article and revising it critically for important intellectual content, and gave final approval of the version to be published. Sumanas W. Jordan, MD, PhD, made substantial contributions to conception and design, analysis and interpretation of data, participated in drafting the article or revising it critically for important intellectual content, and gave final approval of the version to be published. The authors report no conflicts of interest. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Reprints: Dr Gregory A. Dumanian, MD, Orion and Lucille Stuteville Professor of Surgery, Chief of Plastic Surgery, Northwestern Feinberg School of Medicine, 675 North Street Clair, Suite 19-250, Chicago, IL 60611; e-mail: gdumania@nm.org. Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. ISSN: 0003-4932/18/27002-0238 DOI: 10.1097/SLA.0000000000003088 in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment. Conclusions: In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy. Trial Registration: NCT 02205385 at ClinicalTrials.gov. Publisher Copyright: © 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - Objective:To compare targeted muscle reinnervation (TMR) to "standard treatment" of neuroma excision and burying into muscle for postamputation pain.Summary Background Data:To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain.Methods:A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre- and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function.Results:In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus -0.2 (difference 3.4, adjusted confidence interval (aCI) -0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI -0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment.Conclusions:In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy.Trial Registration:NCT 02205385 at ClinicalTrials.gov.
AB - Objective:To compare targeted muscle reinnervation (TMR) to "standard treatment" of neuroma excision and burying into muscle for postamputation pain.Summary Background Data:To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain.Methods:A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre- and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function.Results:In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus -0.2 (difference 3.4, adjusted confidence interval (aCI) -0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI -0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment.Conclusions:In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy.Trial Registration:NCT 02205385 at ClinicalTrials.gov.
KW - neuroma
KW - phantom limb pain
KW - postamputation pain
KW - randomized clinical trial
KW - targeted muscle reinnervation
UR - http://www.scopus.com/inward/record.url?scp=85069882572&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069882572&partnerID=8YFLogxK
U2 - 10.1097/SLA.0000000000003088
DO - 10.1097/SLA.0000000000003088
M3 - Article
C2 - 30371518
AN - SCOPUS:85069882572
SN - 0003-4932
VL - 270
SP - 238
EP - 246
JO - Annals of Surgery
JF - Annals of Surgery
IS - 2
ER -