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Evaluation of Two Randomized Clinical Trials

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  1. Appraisal of Two Randomized Clinical Trials

  2. Low Back Pain RCT • Meade T, et al. Randomised comparison of chiropractic and hospital outpatient management for low back pain: results from extended follow up. BMJ 1995; 311(7001): 349-351. • One of the strongest studies to date supporting chiropractic care of LBP Evidence-based Chiropractic

  3. T. W. Meade • Director of the Medical Research Council Epidemiology and Medical Care Unit, Wolfson Institute of Preventive Medicine, Medical College of St Bartholomew's Hospital, London Evidence-based Chiropractic

  4. Introduction • The authors previously reported that LBP patients treated with chiropractic did better than those receiving hospital outpatient management (followed for 6 months) • This paper presented results for the same group, but three years later • Oswestry questionnaires and pain scales were the outcome measures Evidence-based Chiropractic

  5. Methods • Patients presenting either to a chiropractic clinic or hospital were randomly allocated to either chiropractic or in hospital treatment • Chiropractors used chiropractic manipulation in most patients • Hospital staff most commonly used Maitland mobilization or manipulation Evidence-based Chiropractic

  6. Methods Cont. • 741 patients started treatment • Progress was measured with the Oswestry questionnaire • At six weeks, 95% of chiropractic and 89% of hospital were returned • At three years by 77% and 70% Evidence-based Chiropractic

  7. Methods Cont. • At the three year follow up patients were asked whether they thought their allocated treatment had helped their back pain • Results were analyzed on an intention to treat basis • All patients entering the study were included in the statistical analysis, even if they dropped out Evidence-based Chiropractic

  8. Intention to Treat • Whatever the reason for people failing to complete follow up or not adhering to the protocol, everyone should be analyzed according to the group they were initially allocated to, in other words the group in which they were intended to remain • Dropouts are impossible to include in an intention to treat analysis Evidence-based Chiropractic

  9. Methods Cont. • Differences between group means were tested by unpaired t tests • X2 was used to test for differences in proportions between the two treatment groups Evidence-based Chiropractic

  10. Results Cont. • Mean (SD) Oswestry scores before treatment were 29.8 (14.2) in chiropractic and 28.5 (14.1) in hospital treatment group • 20-40% = moderate disability • There was a 3.18 percentage point difference at three years – a 29% greater improvement in patients treated with chiropractic Evidence-based Chiropractic

  11. Results Cont. Statistically significant Evidence-based Chiropractic

  12. Results Cont. • Pain intensity before treatment and at the various follow up intervals were all positive (improved), but were all significantly greater in those treated by chiropractic • Those with short current episodes, a history of back pain, and initially high Oswestry scores derived the most benefit from chiropractic Evidence-based Chiropractic

  13. Results Cont. TABLE III--Number (percentage) of patients at three year follow up who considered allocated trial treatment had helped their back pain ------------------------------------------------------------------------------------------------- Hospital treatment Chiropractic treatment ------------------------------------------------------------------------------------------------- Referral Help No help Help No help ------------------------------------------------------------------------------------------------- Hospital 71 (60.2) 47 (39.8) 103 (79.2) 27 (20.8) Chiropractic 76 (65.5) 40 (34.5) 127 (84.7) 23 (15.3) ------------------------------------------------------------------------------------------------- For hospital referrals: X2=10.7; P=0.001. For chiropractic referrals: X2=13.3; P<0.0001. Evidence-based Chiropractic

  14. Discussion • The results at six weeks and six months were identical with those in their first report • “The substantial benefit of chiropractic on intensity of pain is evident early on and then persists” • Larger proportions were lost to follow up in those treated in hospital than in those treated by chiropractic suggesting greater satisfaction with chiropractic Evidence-based Chiropractic

  15. Discussion • The authors indicated that there is now more support for the need to conduct rigorous trials focusing on specific components of management • “Meanwhile, the results of our trial show that chiropractic has a valuable part to play in the management of low back pain” Evidence-based Chiropractic

  16. RCT Question List Was the hypothesis stated clearly? H1: Chiropractic ≠ hospital outpatient treatment for managing low back pain Did the trial address a clearly focused issue? Yes Was there an adequate literature review? No. They relied too heavily on their previous article To compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain Evidence-based Chiropractic

  17. RCT Question List Cont. Were an adequate number of subjects used? Yes What were the exclusion and inclusion criteria? Not given Previous article Was the assignment of subjects to each group concealed? ? Were the subjects assigned to groups randomly? Yes Evidence-based Chiropractic

  18. RCT Question List Cont. Were all of the subjects accounted for? Yes Were the groups similar at the start of the study? Yes Were the groups treated equally except for the intervention? No One group was treated in offices and the other in hospitals which may have made a huge difference Evidence-based Chiropractic

  19. RCT Question List Cont. Were the methods adequately described and reproducible? No, but they referred to their 1990 article Treatment at the discretion of the chiropractors, who used chiropractic manipulation in most patients, or of the hospital staff, who most commonly used Maitland mobilization or manipulation, or both Could the differences have been related to patients’ preference for office vs. hospital? Evidence-based Chiropractic

  20. RCT Question List Cont. What outcomes were measured? Oswestry, pain levels, and satisfaction Were all outcomes measured reported? Yes Were the appropriate outcomes assessed? Yes Were statistics calculated correctly? Yes But ANCOVA may have been a better test Mean scores before treatment were 29.8 (chiropractic) and 28.5 (hospital) Evidence-based Chiropractic

  21. RCT Question List Cont. Was the difference between groups statistically and clinically significant? Yes How are the results applicable outside of the study? Generalizable to the typical chiropractic setting Evidence-based Chiropractic

  22. RCT Question List Cont. What do I think are the strengths of this article? Randomization The setting was similar to that of the average chiropractor What do I think are the weaknesses of this article? PTs using manipulation and in hospital Evidence-based Chiropractic

  23. RCT Question List Cont. How would I improve this study? It would have been better to compare with a placebo Compare office-based care for both groups Use ANCOVA to further equalize groups May be able to use less than 741 subjects and get just as powerful results Evidence-based Chiropractic

  24. Neck Pain RCT • Cassidy, J.D., A.A. Lopes, and K. Yong-Hing, The immediate effect of manipulation versus mobilization on pain and range of motion in the cervical spine: a randomized controlled trial. JMPT, 1992. 15(9): 570-5. • One of a handful of studies supporting chiropractic care of neck pain Evidence-based Chiropractic

  25. Cassidy, J.D. • Department of Orthopaedic Surgery, Royal University Hospital, Saskatoon, Saskatchewan, Canada • Involved in the QTF report on whiplash • QTF was generated by an insurance company - Societe d'Assurance Automobile du Quebec (SAAQ) • Was a very biased report Evidence-based Chiropractic

  26. Introduction • Adequate literature review pointing out that neck pain is common • Affects 40-50% of the general population at some point in their lives • Most patients with mechanical neck pain improve with time, but as many as one-third continue to have moderate or severe pain 15 yrs after the initial onset Evidence-based Chiropractic

  27. Introduction Cont. • Pointed out that 5 RCTs had been done, but 3 of them used mobilization as an independent variable • Purpose of the study • To compare the immediate results of manipulation and mobilization on pain and range of motion in patients with unilateral mechanical neck pain Evidence-based Chiropractic

  28. Methods • One hundred consecutive outpatients suffering from mechanical neck pain with radiation into the trapezius region • Population ? 100 consecutive patients • Inclusion/exclusion criteria • Generally good health • Unilateral neck pain aggravated by movement • Without neurological deficit Evidence-based Chiropractic

  29. Methods Cont. • Each patient completed a questionnaire on the history of their neck pain, a Pain Disability Index, and ROM was tested • Patients rated their pain on the NRS-101, a valid and reliable measure of pain • The 101-point Numerical Rating Scale is a progressive numerical scaling method ranging from 0-100, with 0 representing no pain and 100 representing extreme pain Evidence-based Chiropractic

  30. Methods Cont. • All treatments were given once and were applied to the symptomatic side • Within 5 min after treatment, the patients completed a post-test NRS-101 and ROM was retested • ROM was tested with a goniometer Evidence-based Chiropractic

  31. Methods Cont. • Cervical manipulation involved: • Contacting the articular pillar on the painful side of the neck at the level of tenderness with the third finger • Passively rotating the neck away from the painful side as far as possible and applying a high-velocity, low-amplitude thrust in the same direction Evidence-based Chiropractic

  32. Evidence-based Chiropractic

  33. Results • 52 subjects were manipulated and 48 were mobilized without complication • However, 6% of all subjects had increased pain after treatment • The mean (SD) age was 34.5 (13.0) yr for the manipulated group and 37.7 (12.5) yr for the mobilized group • The only demographics that were given Evidence-based Chiropractic

  34. Results Cont. • Pain intensity decreased and range of motion range of motion increased after treatment in both groups • NRS-101 scores decreased 17.3 points in the manipulated group and 10.5 points in the mobilized group • The manipulated group showed greater ROM gains but the differences were not significant Evidence-based Chiropractic

  35. NRS-101 scores Evidence-based Chiropractic

  36. NRS-101 scores (cont.) Manipulation Mobilization PaIn Pre Post Evidence-based Chiropractic

  37. ROM Gain (Change) Scores Evidence-based Chiropractic

  38. Gain (Change) Scores Graph Error Bar Evidence-based Chiropractic

  39. Discussion • The results suggest that both treatments have the immediate effect of decreasing pain and increasing cervical ROM • Overall pain improvement on the NRS-101 was more than 1.5 times greater in the manipulated patients • A long-term trial was suggested to determine which treatment would give the best results over time Evidence-based Chiropractic

  40. Discussion Cont. • The mechanism by which manipulation works is not certain • There is no evidence that it reduces subluxation or that minor positional misalignments are of clinical significance • It is more likely that manipulation affects the pain reflex and/or muscle tension Evidence-based Chiropractic

  41. Discussion Cont. • Cervical spine manipulation has been reported to be associated with rare but serious complications • Stroke in less than 1 in 1,000,000 manipulations • Probably safer than most medical treatments for neck pain Evidence-based Chiropractic

  42. Discussion Cont. • Mobilization is usually very gentle and unlikely to harm patients, even if it has little or no therapeutic benefit • Both risk and benefit are important concerns in the evaluation of treatment options Evidence-based Chiropractic

  43. Conclusion • This study demonstrates that a single manipulation is more effective than mobilization in decreasing pain in patients with mechanical neck pain • Both treatments increase neck ROM to a similar degree Evidence-based Chiropractic

  44. How risky? Comparative Risk of CMT-Related CAD Developing CMT-related ICAD in US/cervical CMT 1:601,145,000 Death from CMT related ICAD in US/cervical CMT 0:3,606,870,000 Death by falling aircraft/year 1:10,000,000 Death by lightning strike/year 1:2,000,000 Developing CMT-related VAD in US/ cervical CMT 1:1,000,000 Death by being struck by an automobile/year 1:20,000 Death related to regular NSAID use/ users 1:4000 Death related to cervical spine surgery/procedures 1:145 Evidence-based Chiropractic

  45. RCT Question List Was the hypothesis stated clearly? Yes H1: chiropractic ≠ mobilization for neck pain Did the trial address a clearly focused issue? Yes Was there an adequate literature review? Yes Were an adequate number of subjects used? Yes Evidence-based Chiropractic

  46. RCT Question List Cont. What were the exclusion and inclusion criteria? • Generally good health • Unilateral neck pain aggravated by movement • Without neurological deficit Was the assignment of subjects to each group concealed? ? Were the subjects assigned to groups randomly? Yes Were all of the subjects accounted for? Yes Evidence-based Chiropractic

  47. RCT Question List Cont. Were the groups similar at the start of the study? Yes Were the groups treated equally except for the intervention? Yes Were the methods adequately described and reproducible? Yes What outcomes were measured? Pain level and ROM Evidence-based Chiropractic

  48. RCT Question List Cont. Were all outcomes measured reported? Yes Were the appropriate outcomes assessed? Yes Were statistics calculated correctly? P=0.05? Was the difference between groups statistically and clinically significant? Yes for pain, No for ROM Evidence-based Chiropractic

  49. RCT Question List Cont. How are the results applicable outside of the study? Not generalizable to the typical chiropractic setting because multiple visits is the norm What do I think are the strengths of this article? Randomization It’s nice to know that patients do better with manipulation immediately after treatment. Evidence-based Chiropractic