Cargando…

Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study

Background: Retrospective studies have described the effectiveness of low-dose radiotherapy (LD-EBRT) in painful arthrosis of small finger joints, but two recent prospective studies have yielded ambiguous results. To generate accurate data for the planning of a trial, we conducted a prospective, mon...

Descripción completa

Detalles Bibliográficos
Autores principales: Hermann, Robert Michael, Trillmann, Annika, Becker, Jan-Niklas, Kaltenborn, Alexander, Nitsche, Mirko, Ruettermann, Mike
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8628986/
https://www.ncbi.nlm.nih.gov/pubmed/34842775
http://dx.doi.org/10.3390/medsci9040066
_version_ 1784607113071296512
author Hermann, Robert Michael
Trillmann, Annika
Becker, Jan-Niklas
Kaltenborn, Alexander
Nitsche, Mirko
Ruettermann, Mike
author_facet Hermann, Robert Michael
Trillmann, Annika
Becker, Jan-Niklas
Kaltenborn, Alexander
Nitsche, Mirko
Ruettermann, Mike
author_sort Hermann, Robert Michael
collection PubMed
description Background: Retrospective studies have described the effectiveness of low-dose radiotherapy (LD-EBRT) in painful arthrosis of small finger joints, but two recent prospective studies have yielded ambiguous results. To generate accurate data for the planning of a trial, we conducted a prospective, monocentric, observational study to describe the effects of LD-EBRT as precisely as possible. Methods: Twenty-five consecutive patients with symptomatic trapeziometacarpal (TMC) arthrosis were irradiated with 6 × 0.5 Gy. Before, 3, and 12 months after LD-EBRT, we assessed subjective endpoints (modified “von-Pannewitz score”, 10-point visual analogue scale (VAS), “patient-rated wrist evaluation” (PRWE)), and objective measurements (“active range of motion” (AROM), Kapandji index, grip strength, pinch grip). Results: At 3/12 months, 80%/57% reported partial and 4%/18% complete remission according to the “von-Pannewitz” score. VAS “overall pain” significantly decreased from a median of seven (IQR 4) at baseline to three (IQR 6; p = 0.046) and to two (IQR 2; p = 0.013). Similar results were obtained for VAS “pain during exercise”, VAS “pain during daytime”, and VAS “function”. “PRWE overall score” was reduced from 0.5 at baseline (SD 0.19) to 0.36 (SD 0.24, p = 0.05) and to 0.27 (SD 0.18, p = 0.0009). We found no improvements of the objective endpoints (AROM, Kapandji, grip strength) except for flexion, which increased from 64° (SD 12°) at baseline to 73° (SD 9.7°, p = 0.046) at 12 months. Conclusions: We recommend the PRWE score as a useful endpoint for further studies for this indication. To prove a 15% superiority over sham irradiation, we calculated that 750 patients need to be prospectively randomized.
format Online
Article
Text
id pubmed-8628986
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-86289862021-11-30 Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study Hermann, Robert Michael Trillmann, Annika Becker, Jan-Niklas Kaltenborn, Alexander Nitsche, Mirko Ruettermann, Mike Med Sci (Basel) Article Background: Retrospective studies have described the effectiveness of low-dose radiotherapy (LD-EBRT) in painful arthrosis of small finger joints, but two recent prospective studies have yielded ambiguous results. To generate accurate data for the planning of a trial, we conducted a prospective, monocentric, observational study to describe the effects of LD-EBRT as precisely as possible. Methods: Twenty-five consecutive patients with symptomatic trapeziometacarpal (TMC) arthrosis were irradiated with 6 × 0.5 Gy. Before, 3, and 12 months after LD-EBRT, we assessed subjective endpoints (modified “von-Pannewitz score”, 10-point visual analogue scale (VAS), “patient-rated wrist evaluation” (PRWE)), and objective measurements (“active range of motion” (AROM), Kapandji index, grip strength, pinch grip). Results: At 3/12 months, 80%/57% reported partial and 4%/18% complete remission according to the “von-Pannewitz” score. VAS “overall pain” significantly decreased from a median of seven (IQR 4) at baseline to three (IQR 6; p = 0.046) and to two (IQR 2; p = 0.013). Similar results were obtained for VAS “pain during exercise”, VAS “pain during daytime”, and VAS “function”. “PRWE overall score” was reduced from 0.5 at baseline (SD 0.19) to 0.36 (SD 0.24, p = 0.05) and to 0.27 (SD 0.18, p = 0.0009). We found no improvements of the objective endpoints (AROM, Kapandji, grip strength) except for flexion, which increased from 64° (SD 12°) at baseline to 73° (SD 9.7°, p = 0.046) at 12 months. Conclusions: We recommend the PRWE score as a useful endpoint for further studies for this indication. To prove a 15% superiority over sham irradiation, we calculated that 750 patients need to be prospectively randomized. MDPI 2021-10-27 /pmc/articles/PMC8628986/ /pubmed/34842775 http://dx.doi.org/10.3390/medsci9040066 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hermann, Robert Michael
Trillmann, Annika
Becker, Jan-Niklas
Kaltenborn, Alexander
Nitsche, Mirko
Ruettermann, Mike
Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title_full Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title_fullStr Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title_full_unstemmed Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title_short Prospective Evaluation of Low-Dose External Beam Radiotherapy (LD-EBRT) for Painful Trapeziometacarpal Osteoarthritis (Rhizarthrosis) on Pain, Function, and Quality of Life to Calculate the Required Number of Patients for a Prospective Randomized Study
title_sort prospective evaluation of low-dose external beam radiotherapy (ld-ebrt) for painful trapeziometacarpal osteoarthritis (rhizarthrosis) on pain, function, and quality of life to calculate the required number of patients for a prospective randomized study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8628986/
https://www.ncbi.nlm.nih.gov/pubmed/34842775
http://dx.doi.org/10.3390/medsci9040066
work_keys_str_mv AT hermannrobertmichael prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy
AT trillmannannika prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy
AT beckerjanniklas prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy
AT kaltenbornalexander prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy
AT nitschemirko prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy
AT ruettermannmike prospectiveevaluationoflowdoseexternalbeamradiotherapyldebrtforpainfultrapeziometacarpalosteoarthritisrhizarthrosisonpainfunctionandqualityoflifetocalculatetherequirednumberofpatientsforaprospectiverandomizedstudy