Static palpation ain’t easy: Evaluating palpation precision using a topographical map of the lumbar spine as a reference

Inge Strøh Hvidkær; Steen Harsted; Maliheh Hadizadeh; Søren O’Neill; Gregory Neil Kawchuk; Casper Nim

doi:10.1371/journal.pone.0304571

Peer Review History

Original SubmissionFebruary 8, 2024
8 Mar 2024 Decision Letter - Barry Kweh, Editor PONE-D-24-02050Static palpation ain’t easy: evaluating palpation precision using a topographical map of the lumbar spine as a referencePLOS ONE Dear Dr. Kawchuk, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Apr 22 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Additional Editor Comments: An interesting study which compares palpation of the lumbar spine by experienced clinicians with topographical methods. A fundamental flaw of this study that modern surgical practice in most centres would necessitate an XR irrespective of how accurate landmarks have been demonstrated to be useful given every patient is individual. The authors need to justify the utility of their method in everyday clinical practice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No Reviewer #3: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes Reviewer #3: No ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thank you for your efforts in compiling this manuscript. I appreciate the opportunity to review it. This manuscript presents important findings that demonstrate the low accuracy of static spine palpation by clinicians. To improve the quality of this article, I suggest that you mention the solutions proposed by literature to enhance the accuracy of this method or alternative methods in the discussion section. Reviewer #2: Hvidkær et al investigate the precision of lumbar spinal palpation by experienced clinicians in treating low back pain. Utilizing data from a previous trial, clinicians marked spinous processes from S1 to T12, and their precision was assessed by comparing these palpation points with a topographical representation of the lumbar lordosis. This is a novel measurement method but does have some concerns about the methodology and clinical meaningful of results The 3-d Wheel method although interesting does bring up some concern. It is unclear if this new method of measurement has been validated. If so, this may be added to the method section. The fact that the plots, in addition to computerized smoothing, required manual adjustment in the Y and X plots does introduce the possibility of Bias which may or may not be random. 1. Further uncertainty in measurement is also inherent to this method such as “breathing, movement, voluntary muscle contraction, or technical errors.“, superficial pen marking, and others which the author acknowledges. The fact that the analysis showed trending nonbias errors also adds to this concern. 2. The method does not indicate whether an a priori study was done to estimate # of patients needed to obtain significance, although this may possibly not be possible as they are using data from another already completed study 3. Clarification of what percentage of data was excluded would also be helpful and whether analysis was performed to see if there was bias on the data excluded/incomplete data 4. Although 95% confidence intervals are shown, data does not show p- p-values when comparisons are done, which could be helpful. 5. The wording “Guidelines for treating non-specific LBP often encourage the use of manual therapy (MT) either as a stand-alone treatment or in combination with other non-pharmacological therapies for non-specific LBP (e.g., exercise)” suggests that the main modality is manipulation and exercises as an adjunct. This is debatable and the wording should reflect that exercise is at least as strongly recommended as a main treatment measure vs other measures. 6. The clinical meaningfulness of ~15mm of imprecision in palpation is unclear. Possible grammatical/formatting errors noted Line 105: “February 1 st 2017 and January 30th 105 2019” –> “February 1st, 2017 and January 30th, 105 2019 “ Reviewer #3: This manuscript analyzes data generated from a clinical (longitudinal) study to evaluate the ability of multiple clinicians to locate the spinous processes through palpation. The study objectives are important, and the study was approved by the respective IRB/ethics board. The analytical methods proposed look straightforward. My comments are as follows: (a) Linear mixed models (LMM) were used to fit "difference in spinous process location" as the response variable. LMMs are based on Gaussian assumptions of the random effects and errors. It is not clear if the authors assessed possible non-Gaussian behavior of the random terms, and thus suggest alternatives. (b) Within the linear mixed model implementation, it is not clear which covariates were controlled for. (c) In the results section, every claim of significance should be followed by a p-value, thereby providing the strength of significance/non-significance. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes: Sina Afzal Reviewer #2: No Reviewer #3: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". 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Revision 1
30 Apr 2024 Author Response General comments We thank the Editor and Reviewers for providing precise and clear review comments. We have provided a point-by-point response and uploaded a tracked-changed manuscript for your perusal. We agree with nearly all of the comments and have updated the manuscript accordingly. In the case where we disagreed, we have attempted to expand on details already within the manuscript to clarify our statements and have provided explicit comments on reasons for not modifying the manuscript. Again, we thank you all for taking the time to review our manuscript with such rigor, and the comments and modifications to the manuscript have definitely improved it. Thank you. Editor Comments: Comment E1#0 An interesting study which compares palpation of the lumbar spine by experienced clinicians with topographical methods. A fundamental flaw of this study that modern surgical practice in most centres would necessitate an XR irrespective of how accurate landmarks have been demonstrated to be useful given every patient is individual. The authors need to justify the utility of their method in everyday clinical practice. Response E1#0 Thank you for the comment. We agree that the results of imprecise static palpation do not have the same consequence on all professions, and where precision is really needed, such as surgical procedures, more rigorous tools are used instead of relying simply on static palpation. In our discussion we have now included additional detail on how the results impact palpation methods in various clinical practices: “Our results have clinical implications for all professions that rely on static palpation for interventions, such as manual therapists, chiropractors, physiotherapists, etc, but also for other profession such as anesthesiologists who have to make precise indications when providing spinal epidurals [34]. In the field of MT, the effects of being specific to a single vertebral level may not be of particular relevance [32,33] to the treatment effect, so whether a clinician is off by 1 vertebra is likely not important for the effect of the treatment. Nevertheless, it is relevant that the practitioners who perform MT is aware of the low accuracy of static spine palpation as it could affect their understanding of how MT works and what they explain to the patient. However, for anesthesiologists and surgeons ~15mm of imprecision has an impact for their procedures. Therefore, our results emphasized the need for aid in these procedures, (e.g., ultrasound to make a precise injection for spinal epidurals and fluoroscopic placing of needles before spine surgery), which already take place in daily modern practice [35-37].” Reviewer 1 Comment R1#0 Thank you for your efforts in compiling this manuscript. I appreciate the opportunity to review it. This manuscript presents important findings that demonstrate the low accuracy of static spine palpation by clinicians. To improve the quality of this article, I suggest that you mention the solutions proposed by literature to enhance the accuracy of this method or alternative methods in the discussion section. Response R1#0 This is a very good point, which we have added at the end of the discussion: “Our results have clinical implications for all professions that rely on static palpation for interventions, such as manual therapists, chiropractors, physiotherapists, etc, but also for other profession such as anesthesiologists who have to make precise indications when providing spinal epidurals [34]. In the field of MT, the effects of being specific to a single vertebral level may not be of particular relevance [32,33] to the treatment effect, so whether a clinician is off by 1 vertebra is likely not important for the effect of the treatment. Nevertheless, it is relevant that the practitioners who perform MT is aware of the low accuracy of static spine palpation as it could affect their understanding of how MT works and what they explain to the patient. However, for anesthesiologists and surgeons ~15mm of imprecision has an impact for their procedures. Therefore, our results emphasized the need for aid in these procedures, (e.g., ultrasound to make a precise injection for spinal epidurals and fluoroscopic placing of needles before spine surgery), which already take place in daily modern practice [35-37].” Furthermore, we have added additional information on how experience impacts our results in the second section of the discussion: “Interestingly, this persisted across all participants and clinicians, despite utilizing clinicians with great experience and who were well-trained on the study procedures. Our results might have shown even more considerable differences if using more novice clinicians [31].” Reviewer 2 Comment R2#0 Hvidkær et al investigate the precision of lumbar spinal palpation by experienced clinicians in treating low back pain. Utilizing data from a previous trial, clinicians marked spinous processes from S1 to T12, and their precision was assessed by comparing these palpation points with a topographical representation of the lumbar lordosis. This is a novel measurement method but does have some concerns about the methodology and clinical meaningful of results. The 3-d Wheel method although interesting does bring up some concern. It is unclear if this new method of measurement has been validated. If so, this may be added to the method section. The fact that the plots, in addition to computerized smoothing, required manual adjustment in the Y and X plots does introduce the possibility of Bias which may or may not be random Response R2#0 Thank you for this comment, we agree on the concern that you raise. While the 3D method has not been “validated” directly there are multiple validation papers for this device including a bench-top accuracy, and a comfort study. We have cited these and other relevant references. Additionally, a strict protocol was followed during data collection. We also agree that our method where the plots in the Y-axis and X-axis were manually adjustment does add a certain degree of uncertainty in our assessment, which is why we used 3 raters to independently assess the smoothed plots. However, this is a valid concern and we have modified the final statement in the limitations section under the discussion: "Lastly, we aligned the trajectories by manually shifting them based on assessing computerized smoothed plots that were mathematically aligned. We used three raters to conduct the translational process to reduce bias in this approach. Although there may be other ways to complete this spatial synchronization of stiffness data, we have confidence in our approach [17]. Any mistranslations should not have resulted in more than minor changes." Comment R2#1 Further uncertainty in measurement is also inherent to this method such as “breathing, movement, voluntary muscle contraction, or technical errors.“, superficial pen marking, and others which the author acknowledges. The fact that the analysis showed trending nonbias errors also adds to this concern. Response R2#1 We agree with the Reviewer and have already placed emphasizes on these as limitations to our study. Additionally and in relation to the prior comment, we have already expanded on how this might impact our results (please see Response R2#0 above). We have not made additional changes to the manuscript Comment R2#2 The method does not indicate whether an a priori study was done to estimate # of patients needed to obtain significance, although this may possibly not be possible as they are using data from another already completed study Response R2#2 As you mention, this study is a secondary analysis of a study that was built on a priori sample size estimates. Therefore, we did not have the possibility to make an a priori study to estimate the needed number of participants to gain significance. We have now elaborated on this in the statistical analysis in the method under the section “Number of participants” “As this study was a secondary analysis using palpation data from a prospective randomized trial [21] no a priori sample size was performed to calculate the number of participants needed to obtain significance, instead we relied on the total patient population at each time point. We did not conduct power analyses, as most of our results in palpation clearly were different from zero.” Comment R2#3 Clarification of what percentage of data was excluded would also be helpful and whether analysis was performed to see if there was bias on the data excluded/incomplete data Response R2#3 We have inserted percentages with the count values in the descriptive data section. We did not conduct any dropout analyses as we do not consider that dropout would affect our aim. Specific patient characteristics may be related to dropout, however, it should not affect the precision of palpation especially since it was only female characteristics that were associated with lightly less precise palpation. Comment R2#4 Although 95% confidence intervals are shown, data does not show p- p-values when comparisons are done, which could be helpful Response R2#4 Thank you for this comment, we prioritized only showing the 95% confidence intervals as these provide more meaningful estimates of the strength of the association. As our Tables are only placed in the supplementary material, we have inserted the p-values as requested. Additionally, we have also inserted p-values for the ICC models. However, it does not make sense to calculate p-values for limits of agreement Comment R2#5 The wording “Guidelines for treating non-specific LBP often encourage the use of manual therapy (MT) either as a stand-alone treatment or in combination with other non-pharmacological therapies for non-specific LBP (e.g., exercise)” suggests that the main modality is manipulation and exercises as an adjunct. This is debatable and the wording should reflect that exercise is at least as strongly recommended as a main treatment measure vs other measures. Response R2#5 We have modified this sentence in the introduction to make it clear that manual therapy is not preferred over for instance exercise. “Guidelines for treating non-specific LBP encourage different treatment modalities such as manual therapy (MT), exercise and patient education. These modalities can be employed either individually as standalone treatments or in combination [3,4]. However, when clinicians utilizes MT as a treatment option, they often apply static manual palpation to identify the application site for MT as a specific site is considered clinically advantageous [(5–7]). Comment R2#6 The clinical meaningfulness of ~15mm of imprecision in palpation is unclear. Response R2#6 Thank you for this comment, we have provided more detailed answer in response E1#0 and R1#0. In the manuscript, we have elaborated on this topic at the end of the discussion: “Our results have clinical implications for all professions that rely on static palpation for interventions, such as manual therapists, chiropractors, physiotherapists, etc, but also for other profession such as anesthesiologists who have to make precise indications when providing spinal epidurals [34]. In the field of MT, the effects of being specific to a single vertebral level may not be of particular relevance [32,33] to the treatment effect, so whether a clinician is off by 1 vertebra is likely not important for the effect of the treatment. Nevertheless, it is relevant that the practitioners who perform MT is aware of the low accuracy of static spine palpation as it could affect their understanding of how MT works and what they explain to the patient. However, for anesthesiologists and surgeons ~15mm of imprecision has an impact for their procedures. Therefore, our results emphasized the need for aid in these procedures, (e.g., ultrasound to make a precise injection for spinal epidurals and fluoroscopic placing of needles before spine surgery), which already take place in daily modern practice [35-37].” Comment R2#7 Possible grammatical/formatting errors noted. Line 105: “February 1 st 2017 and January 30th 105 2019” –> “February 1st, 2017 and January 30th, 105 2019 “ Response R2#7 Thank you for making us aware. We have rewritten using a Month/Day/Year format, dates now read: February 1st, 2017 etc. Reviewer 3 Comment R3#0 This manuscript analyzes data generated from a clinical (longitudinal) study to evaluate the ability of multiple clinicians to locate the spinous processes through palpation. The study objectives are important, and the study was approved by the respective IRB/ethics board. The analytical methods proposed look straightforward. My comments are as follows: Linear mixed models (LMM) were used to fit "difference in spinous process location" as the response variable. LMMs are based on Gaussian assumptions of the random effects and errors. It is not clear if the authors assessed possible non-Gaussian behavior of the random terms, and thus suggest alternatives. Response R3#0 Thank you for this comment, we did not initially include this in the manuscript. However, we did check for model assumptions, and this has now been inserted at the very end of the statistical analysis section: “All linear regressions models were checked for assumptions for normality of residuals by inspecting QQ-plots, linearity, and homogeneity of variance. All models upheld these assumptions.” For simplicity, we added the results directly in the method section as well. Thank you for making us aware. Comment R3#1 Within the linear mixed model implementation, it is not clear which covariates were controlled for. Response R3#1 We did not assess any other covariates that were controlled for. We have inserted “No covariates were included for the regression models.” at the bottom of the Precision of palpation section in the method, to clarify this. Comment R3#2 In the results section, every claim of significance should be followed by a p-value, thereby providing the strength of significance/non-significance. Response R3#2 Thank you for this comment, we prioritized only showing the 95% confidence intervals as these provide more meaningful estimates of the strength of the association. However, as our Tables are only placed in the supplementary material, we have inserted the p-values as requested. Additionally, we have also inserted p-values for the ICC models. However, it does not make sense to calculate p-values for limits of agreement Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0304571.r002
15 May 2024 Decision Letter - Barry Kweh, Editor Static palpation ain’t easy: evaluating palpation precision using a topographical map of the lumbar spine as a reference PONE-D-24-02050R1 Dear Dr. Kawchuk, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Barry Kweh Academic Editor PLOS ONE Additional Editor Comments (optional): A well written article which addresses the suggestions proposed by the reviewers. In particular, the usefulness of this static palpation method concerning non-surgical as well as surgical specialties. Reviewers' comments: https://doi.org/10.1371/journal.pone.0304571.r003
Formally Accepted
20 May 2024 Acceptance Letter - Barry Kweh, Editor PONE-D-24-02050R1 PLOS ONE Dear Dr. Kawchuk, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Barry Kweh Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0304571.r004

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