November Articles-Author Questions

Copyright © January 2006 Ted Nissen

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TABLE OF CONTENTS

1         What other research studies have followed this one and have added to our knowledge of subacute low-back pain? If you have pdf files please forward. 3

2         Can we get charts and other ancillary material depicting/describing stretches/postural education massage techniques used in this study? 3

3         Are copies of tests used in the study available? For example; Roland Disability Questionnaire (RDQ), McGill Pain Questionnaire (LF-MPQ) Long Form, State-Trait Anxiety Inventory Form Y (STAI), & Modified Schober test. 3

4         Were the distributions of the individual groups and combined scores of all the groups normal or skewed negative/positive? 3

5         Outcome Measures for this study indicate P-Values at follow-up of .04 between the Modified Schober Groups (Significant Differences between Groups) but .51 post treatment (No Difference). Since this may indicate a treatment effect between groups at follow-up why didn’t you report this? Did you complete further factor analysis to determine which groups were affected? What does it mean? 3

6         What was the funding source for this project? How much was the funding grant for? Were the subjects paid and if so how much? When you (author) provided treatment in the place of an unavailable massage therapist were you paid and what percentage of treatment did you provide? 4

7         How were the treatment providers selected? 4

8         Pedro  (Physiotherapy Evidence Database) rates this research as follows; 6 out of 10 possible (see Pedro Validity Standards). None of the following research elements were noted; Concealed Allocation, Blind Subjects, Blind Therapists, and Intention to treat analysis. Do you agree with Pedro’s analysis? 5

9         Please clarify the apparent discrepancy between these two research findings from your study; 5

10       At follow-up the soft-tissue manipulation group (Group # 2) was not distinguishable from Group 3 (exercise group). If this is true how can Group 1 be statistically superior to group 3 (also a finding in the study) since there are no statistical differences between group 1 and group 2 at follow-up? 6

11       Why did the author find it necessary to mention “College of Massage Therapists” in her summary conclusion when regulation of massage technique & the experience of the massage therapists are not measured variables in this research? 6

12       I can find no reference   , which determines the validity of using the PPI McGill pain scale, which is essentially an ordinal scale as a ratio scale (used in your study to determine percentage of subjects with no pain). The McGill appears to have been validated as an interval scale. Please let me know if you have additional references? 6

13       Several comparisons between groups, both at post treatment and at follow-up, were not mentioned in this research paper. These are listed in the following chart in parenthesis; Outcome Measures Results Can we assume that this is because there are no significant differences between these groups? 7

 

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Research Article: Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ 2000;162(13):1815-20.

Online Article: http://www.cmaj.ca/cgi/reprint/162/13/1815

1      What other research studies have followed this one and have added to our knowledge of subacute low-back pain? If you have pdf files please forward.

1.1       Authors Response

1.1.1       I have conducted no further studies on treatment for subacute low back pain.

2     Can we get charts and other ancillary material depicting/describing stretches/postural education massage techniques used in this study?

2.1      Authors Response

2.1.1      I do not have these readily available.

2.2     Analysis

2.2.1     This is unfortunate, given that the author makes the claim in question # 11 of this paper that the results are not generalizable to other therapies which may seem similar. The descriptions in the research paper are sketchy and do not distinguish these techniques from those used in other settings. It is impossible to fully evaluate the author’s claim without further demonstration of the technique as requested in this question. The author is asking us to trust that this is so.

3     Are copies of tests used in the study available? For example; Roland Disability Questionnaire (RDQ), McGill Pain Questionnaire (LF-MPQ) Long Form, State-Trait Anxiety Inventory Form Y (STAI), & Modified Schober test.

3.1      Authors Response

3.1.1      Yes, these measures are readily available; however, one must purchase the Anxiety Inventory.

4     Were the distributions of the individual groups and combined scores of all the groups normal or skewed negative/positive?

4.1      Authors Response

4.1.1      The distributions were normal.

5      Outcome Measures for this study indicate P-Values at follow-up of .04 between the Modified Schober Groups (Significant Differences between Groups) but .51 post treatment (No Difference). Since this may indicate a treatment effect between groups at follow-up why didn’t you report this? Did you complete further factor analysis to determine which groups were affected? What does it mean?

5.1      Authors Response

5.1.1      This is a good question. This result was reported in Table 3, but not discussed. While it appears that the participants in the comprehensive massage therapy group had the greatest range of motion at one-month follow up, you might note that due to scheduling difficulties, not all the participants in the soft tissue manipulation group underwent this test. I therefore did not have confidence in this finding especially since the sample sizes were somewhat small.  As you know, there are revisions and editions requested by journal editors and pressure to streamline the manuscript – not everything in the first manuscript submission appears in the published version.

6     What was the funding source for this project? How much was the funding grant for? Were the subjects paid and if so how much? When you (author) provided treatment in the place of an unavailable massage therapist were you paid and what percentage of treatment did you provide?

6.1      Authors Response

6.1.1      As noted in the article, the College of Massage Therapists funded the study ($38,000). When I provided treatment which was rare (perhaps 1-2%), I did not reimburse myself.

7     How were the treatment providers selected?

7.1      Authors Response

7.1.1      At the time of the study, the study site was new and still in the process of becoming fully developed. The coordinator of the Centre had recently interviewed several people for the Centre, and this coordinator assisted with locating appropriate personnel for the study.

7.2     Analysis

7.2.1      

8        Pedro  (Physiotherapy Evidence Database) rates this research as follows; 6 out of 10 possible (see Pedro Validity Standards). None of the following research elements were noted; Concealed Allocation, Blind Subjects, Blind Therapists, and Intention to treat analysis. Do you agree with Pedro’s analysis?

8.1      Authors Response

8.1.1      This is not entirely correct. Data were analyzed by intention to treat.

8.1.2     It would be difficult if not impossible to blind subjects and therapists to treatment allocation; however, subjects were blind to purpose and the use of a placebo.

8.2     Analysis

8.2.1     Pedro is not clear about how they determine whether statistical analysis (Intention to Treat Analysis) was done on treatment variables even though a person dropped out of the study before completion. Pedro cites the research link below which seems to require explicit description and intention to treat analysis included in the research paper. It may be that you don’t get credit unless you clearly say that you analysed all of the outcome measures even if someone dropped out. In this case this study does not detail a description of the intention to treat analysis and so despite the authors current claim that intention to treat analysis was performed it has to be documented clearly in the research which was not done. The author is asking us to trust that she performed the intention to treat analysis without any material demonstration that this analysis was in fact done.

8.2.2    Intention to Treat Research cited by Pedro

8.2.2.1   http://www.bmj.com/cgi/content/short/319/7211/670

8.2.3    The author states that it “would be difficult if not impossible to blind subjects and therapists to treatment allocation”. The term allocation concealment technically applies only to the screener’s inability to see the allocation of subjects to groups by the assignment person. The author seems to confuse this term “concealed allocation” with blinding therapists that is insuring that therapists don’t know which groups are supposed to be therapeutic. The author conflates these two terms into one term “treatment allocation” claiming it to be impractical. We will pull these two terms apart and deal with them separately as this is a mistaken use of the term by the researcher.

8.2.4    In this study there was no description of procedures for allocation concealment (Definition). There are several accepted and well established measures which effectively conceal allocation (Proceedures). The researchers claim that allocation concealment is difficult/impossible is simply not true. The author could be ignorant of basic research and design methodology which seems implausible given her current active involvement as a research professor at a prominent Canadian University. This author could also be attempting to spin (misleading interpretation of material facts and or introduction of irrelevant information to argue in support of a false conclusion) a defence for what is an obvious design flaw in the research.

8.2.5    There is other evidence of spin on the part of the researcher in defending this study. (spin) There may be other explanations for this behavior which should be considered given the affect that this particular description would have on the reader’s ability to trust the judgements and recollections of the researcher.

8.2.6    After all how trust worthy is a person who knowingly misleads readers into supporting a false conclusion? How would you know what was true and what wasn’t? In some instances you have to take the researchers word for information which is unverifiable. For example this researcher has claimed that the distribution of the data for this research study are normal (this might allow us to verify bias), that she only saw patients 1-2% of the time, did not get paid for her service, had no personal relationships with the therapists who provided research in the study and other material facts which would affect the validly of research conclusions.

8.2.7    How can we trust that these material facts are correct if there is evidence of spin? Spin by definition implies a misleading interpretation of material facts. What is truth and what isn’t becomes a valid concern with this research. It certainly is possible that the author is telling the truth about some things and spinning others. Whether these are outright lies or if there is actual fraud is impossible to tell.

8.2.8    The advice to researchers is simple; defend your position where possible but it is probably better to admit error rather than sacrifice trust. In the long run it is likely that people will see thru half truths and misleading arguments and not trust any of the conclusions of the research study. The short term benefit to reputation that spinning away embarrassing research errors may provide is offset by the long term mistrust of research findings. It certainly isn’t worth it to the funding source if no one trusts the research they financially sponsor.

8.2.9    The second assertion that it is difficult or impossible to blind therapists may be true. It will require more research to determine whether creative solutions to this problem have been devised. How would you blind therapists or for that matter subjects to which of the groups had the measured treatment? The blinding technique is well suited for drug therapies where a placebo pill is made to look like the real pill. How do you make it difficult/impossible for both therapist and subject to know which therapeutic intervention is real? Most massage therapists/subjects would be suspicious for example if you tried to sell a sham (fake) therapeutic intervention that was applied to a different area of the body than the problem area. Then again how would you avoid an unwanted treatment effect if you did apply treatment to the affected area? This problem may have been resolved already and it will be interesting to see how.

8.2.10 This does not mean that this research or any research in the field of touch therapy should be exempted from rating this good research criterion. It will hopefully motivate researchers to develop creative solutions which blind both therapists and subjects to insure that they are not influencing the outcome of the research and the therapeutic intervention is. The excuse that this researcher promotes that it is difficult or impossible would probably not be acceptable to the scientific community.

9     Please clarify the apparent discrepancy between these two research findings from your study;

9.1       At the 1-month follow-up, 63% of the subjects in the comprehensive massage therapy group reported no pain, as compared with 27% in the soft-tissue manipulation group…

9.2     At follow-up there were no statistical differences between the comprehensive massage therapy group and the soft-tissue manipulation group

9.3     Authors Response

9.3.1     At follow-up the soft-tissue manipulation group (Group # 2) was not distinguishable from Group 3 (exercise group). If this is true how can Group 1 be statistically superior to group 3 (also a finding in the study) since there are no statistical differences between group 1 and group 2 at follow-up? 

10 At follow-up the soft-tissue manipulation group (Group # 2) was not distinguishable from Group 3 (exercise group). If this is true how can Group 1 be statistically superior to group 3 (also a finding in the study) since there are no statistical differences between group 1 and group 2 at follow-up?

10.1    Authors Response

10.1.1   The difference between group 2 and 3 was not statistically significant, while the difference between group 1 and 3 was statistically significant.

11   Why did the author find it necessary to mention “College of Massage Therapists” in her summary conclusion when regulation of massage technique & the experience of the massage therapists are not measured variables in this research?

11.1     Authors Response

11.1.1    I do not see College of MT in the summary conclusion. It is important to note that the effectiveness suggested in this study is only associated with comprehensive massage therapy by experienced therapists with additional training, and so forth as noted in the article. The findings are not generalizable to other form of therapies that one might consider similar.

11.2    Analysis

11.2.1   The author could find the reference if she had looked. For your convenience it is highlighted with the following link.

11.2.1.1   http://www.anatomyfacts.com/research/abstractlb.bmp

11.2.2  It does appear to be a blatant plug of the college of massage therapists which funded this research project and of which she was registered. This plug may be hard to defend if she had acknowledged awareness of it. The author seems to want to defend her inclusion of the plug without acknowledging its existence. Ms. Preyde asserts that the additional training and experience of the massage therapists providing treatment in her study did affect the quality of service provision. Ms. Preyde further asserts that the superior outcome that comprehensive massage therapy affords can not be generalized to treatments which may only seem similar.  Ms. Preyde’s aforementioned conclusion is not supported by the evidence and is irrelevant to the variables measured in this research. This research study does not measure the experience of therapists, the amount of training they received, what institution registered them or how those variables in combination affected the administration of the measured variable comprehensive massage.  In addition at least a part of the comprehensive massage treatments were not provided by massage therapists but rather a certified personal trainer/weight-trainer supervisor whose experience or training is not known. This appears to be some type of spin (misleading interpretation of facts to the advantage of a premise) on the part of Ms. Preyde which avoids taking responsibility for an error in judgement or worse is just a reasoned and conscious intent to deceive. Ms. Preyde should not have inserted the plug in the first place. The spin that Ms. Preyde advances assumes ignorance and lack of scientific sophistication on the part of the reader. It seems obvious Ms. Preyde intends to manipulate our perception of this study so that we may favour the college of massage therapists as a training institution. This casts unnecessary doubt on her other recollections or analysis. How can we, the reader, trust Ms. Preyde recollections and answers to other questions when something she denies seeing is in such plain sight and further something she defends anyway as if she knew it were there all along. We would have to give her points for loyality and political savvy even at the expense of good science.

12 I can find no reference [1] [2] [3], which determines the validity of using the PPI McGill pain scale, which is essentially an ordinal scale as a ratio scale (used in your study to determine percentage of subjects with no pain). The McGill appears to have been validated as an interval scale. Please let me know if you have additional references?

12.1    Authors Response

12.1.1   I am sorry, I do not have other references.

12.2   Analysis

12.2.1   

13 Several comparisons between groups, both at post treatment and at follow-up, were not mentioned in this research paper. These are listed in the following chart in parenthesis; Outcome Measures Results Can we assume that this is because there are no significant differences between these groups?

13.1    Authors Response

13.1.1   I think the important statistically significant differences were noted in the article.



[1] Prieto Ej, Hopson L, Bradley La, Byrne M, Geisinger Kf, Midax D, Et Al. (Feb 1980). The language of low back pain: factor structure of the mcgill pain questionnaire. Pain, 8(1), pp. 11 - 19.

[2] Mccreary C, Turner J, Dawson E. (Aug 1981). Principal dimensions of the pain experience and psychological disturbance in chronic low back pain patients. Pain, 11(1), pp. 85 - 92.

[3] Wright Kd, Asmundson Gj, Mccreary Dr. (2001). Factorial validity of the short-form mcgill pain questionnaire (sf-mpq). Eur J Pain, 5(3), pp. 279 - 284.