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Page57-68_mcreynolds

ORIGINAL CONTRIBUTION
Intramuscular Ketorolac Versus Osteopathic Manipulative Treatment
in the Management of Acute Neck Pain in the Emergency Department:
A Randomized Clinical Trial

Tamara M. McReynolds, DOBarry J. Sheridan, DO Ketorolac tromethamine injected intramuscularly (IM)
In the ED, providing pain relief for patients with neck has been shown to be an effective analgesic in treating
pain is the primary goal—after any significant pathology patients with acute musculoskeletal pain in the emer-
or injury has been excluded from diagnostic evaluation.
gency department (ED). The authors compare the efficacy
Patients are commonly treated with nonsteroidal anti- of a single dose of IM ketorolac to osteopathic manipula-
inflammatory drugs (NSAIDs). Osteopathic manipulative tive treatment (OMT) as delivered in the ED for the man-
treatment (OMT) is another treatment modality that may be agement of acute neck pain. A randomized clinical trial was
considered, however. Manipulation of the cervical spine for conducted in three EDs. A convenience sample of 58
neck pain (and headache) is the second most common use of patients with acute neck pain of less than three weeks’
duration were enrolled. Subjective measures of pain inten-
Osteopathic manipulative treatment is based on osteo- sity on an 11-point numerical rating scale were gathered
pathic principles and practice. Fundamental to the science and from patients immediately before treatment and one hour
art of osteopathic medicine is the recognition of the body’s afterward. Subjects received either OMT or 30 mg,
inherent ability to restore homeostasis and heal itself. Various IM ketorolac. Subjects’ perceived pain relief was also
osteopathic manipulative (OM) techniques are applied in recorded at one hour after treatment on a subjective
regions of somatic dysfunction (ie, areas of impaired or altered 5-point pain relief scale. Twenty-nine patients received
function of the body framework) to promote blood flow IM ketorolac, and 29 patients received OMT. Although
through the tissues, thus enhancing the body’s own both groups showed a significant reduction in pain inten-
sity, 1.7Ϯ1.6 (P Ͻ.001 [95% CI, 1.1–2.3]) and 2.8Ϯ1.7 (P Ͻ.001
Terminology used to describe manual therapies varies.
[95% CI, 2.1–3.4]), respectively, patients receiving OMT
Osteopathic physicians use the term manipulation to describe reported a significantly greater decrease in pain intensity
over 100 different OM techniques.3 In the literature, many (Pϭ.02 [95% CI, 0.2–1.9]). When comparing pain relief
researchers use the term manipulation to describe high velocity, at one hour posttreatment, there was no significant dif-
low amplitude (HVLA) thrust techniques. A thrust is a force ference between the OMT and ketorolac study groups
applied to the joint that moves it beyond the passive range of (Pϭ.10). The authors found that, at one hour posttreat-
motion and often produces an audible click at the joint.4 ment, OMT is as efficacious as IM ketorolac in providing
Mobilization is a nonthrust form of manipulation5-7 pain relief and significantly better in reducing pain inten-
that applies a manual force to the spinal joints within the sity. The authors conclude that OMT is a reasonable alter-
native to parenteral nonsteroidal anti-inflammatory med-
The term manipulation in our study describes manipu- ication for patients with acute neck pain in the ED setting.
lative therapies as used by chiropractors, physiotherapists,other “manual therapists,” and osteopathic physicians— Acute musculoskeletal neck pain is a common complaint as when we inquired of study subjects prior to study enroll- among the general population in the United States and ment if they had ever received “prior manipulation.” The is a frequent problem for patients presenting to the emer- term osteopathic manipulative treatment (ie, OMT), however, gency department (ED). Up to 71% percent of Americans is used in our study only when osteopathic physicians can recall experiencing an episode of neck pain or stiffness in in the treatment of patients use OM techniques. In this study, the OM techniques used by osteopathic physicians include HVLA thrust, soft tissue, and muscle energy techniques.
From the Departments of Emergency Medicine at Darnall Army Community Although expert panels, studies, and reviews have found Hospital in Fort Hood, Tex, and Brooke Army Medical Center at Fort Sam manipulation to be effective in the reduction of acute,8,9 subacute,10 and chronic low back pain,11 there is a lack of Address correspondence to Barry J. Sheridan, DO, 3851 Roger Brooke Dr, Fort Sam Houston, San Antonio, TX 78234-6200.
data from randomized controlled trials on the benefits of E-mail: tamara.mcreynolds1@us.army.mil manipulation for acute neck pain.7,12 Manipulation7,8 and McReynolds and Sheridan • Original Contribution JAOA • Vol 105 • No 2 • February 2005 • 57
ORIGINAL CONTRIBUTION
Figure. Acute neck pain in the emergency department: ketorolac
tromethamine injected intramuscularly versus osteopathic manipu-

Checklist
lative treatment. Study inclusion and exclusion criteria. Inclusion Criteria
Ⅲ Acute musculoskeletal neck pain of less than three Ⅲ Patient aged between 18 years and 50 years Exclusion Criteria*
Ⅲ Bleeding ulcer (or peptic ulcer disease) 7,8,13 are probably more effective treatment modal- ities than is standard care provided by a general practitioner Ketorolac tromethamine injected intramuscularly (IM) has been shown to be an effective analgesic in treating acute Ⅲ Engaged in litigation or receiving compensation musculoskeletal pain in the ED.14-17 There have been no Ⅲ Hypersensitivity to nonsteroidal anti-inflammatory studies evaluating the efficacy of OMT in the treatment of patients with acute neck pain in the emergency department.
Therefore, the purpose of this study is to compare the clinical efficacy of a single dose of IM ketorolac with a single inter- vention with OMT in the treatment of acute neck pain in patients presenting to the ED. We hypothesized that OMT was as efficacious as IM ketorolac in providing pain relief for We conducted a randomized clinical trial that compared the Ⅲ Radiographic contraindications to osteopathic use of OMT to IM ketorolac for the relief of acute neck pain. The Brooke Army Medical Center Institutional Review Board in the Ⅲ Received treatment with any of the following Department of Clinical Investigation at Fort Sam Houston in San Antonio, Texas, approved this study. All study subjects This study was conducted at three ED teaching hospi- tals: two Level I urban trauma centers, and one Level III com- munity hospital. All three facilities have an annual census of Fifty-eight patients were enrolled by convenience sampling Ⅲ Temperature higher than 37.8ЊC (Ͼ100ЊF) Ⅲ Trauma classified as substantial with distracting over 3 and one half years, from January 1999 through June 2002.
injuries, alcohol involvement, or other factors Eligible patients included those presenting to the ED during shifts in which at least one of the three enrolling physicians were present. The two authors (T.M.M. and B.J.S) and oneadditional osteopathic physician were enrolling physicians.
* Exclusion criteria was evaluated based on current findings upon physical examination or in subsequent laboratory testing, by direct All three enrolling physicians were osteopathic physicians evidence or a high index of suspicion for a given condition or disease, that specialize in emergency medicine and routinely use OMT or in a prior diagnosis as revealed in history taking.
† In addition to inflammatory joint disease, rheumatoid arthritis and for patient treatment in the ED. Schedules were variable and ankylosing spondylitis were also exclusion criteria for this study.
‡ Patients were excluded from this study if they had evidence of did not correspond to any particular time of day or day of neurologic deficit such as signs of cervical myelopathy, progressive unilateral muscle weakness, motor loss, or sensory loss.2 § Patients were excluded from this study if they had suspected or Patients were given the option to refuse study enrollment known (ie, diagnosed in prior testing) cervical radiculopathy orsensory changes that include paresthesia or hyperesthesia (or both) at the time informed consent was requested. Potential sub- of a dermatomal distribution, or pain radiation into the upperextremity that follows a dermatomal pattern.2 jects were enrolled in the study if inclusion criteria were met See Methods, on pages 59-60 of this article, for more information and none of the exclusion criteria applied (Figure).
on radiographic contraindications for osteopathic manipulativetreatment as used in the current study.
Enrolling physicians randomly assigned patients to receive ¶ Patients were excluded from this study if they had received treatment with intramuscular ketorolac or manipulation for the current episode either OMT or IM ketorolac using a predetermined random Trauma caused in an average “fender-bender” automobile accident 18 The treatment arm was not disclosed to patients until after informed consent was obtained. Attempts were not 58 • JAOA • Vol 105 • No 2 • February 2005
McReynolds and Sheridan • Original Contribution ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Characteristics of Study Subjects (N=58)
Osteopathic Manipulative
Ketorolac Group (n=29)
Treatment Group (n=29)
Characteristic
P
Age, y
Symptom Duration (Median), d*
Treatment Modalities
Previously Used
Nonsteroidal anti-inflammatory drugs† Ⅲ Etiology of Pain
* The range for symptom duration was 1 to 7 days for the ketorolac group and 1 to 15 days for the osteopathic manipulative treatment group.
† Patients were asked if they had used nonsteroidal anti-inflammatory drugs in the past 24 hours.
‡ As noted in Figure, two of the exclusion criteria for this study were the use of manipulation or intramuscular ketorolac for the current incident of pain. The eight patients who reported having received manipulation in the past did not receive it for the current incident of pain prior to enrollment in this study.
made to blind patients or physicians as to which treatment was ▫ anomalies that were congenital (eg, unstable os odon- being given at the time of treatment.
Radiographs of the cervical spine were obtained if there ▫ anteroposterior spinal canal stenosis of greater than 11 mm, was a history of trauma and if patients were unable to be ▫ bone diseases including infections (eg, discitis, osteomyelitis, cleared clinically. Radiographic contraindications to manipu- lation2 used in this study included, but were not limited to, the ▫ fractures that were acute or unhealed, ▫ misalignment that was obvious (of Ͼ3 mm of transloca- ▫ active inflammatory arthritis (ankylosing spondylitis, ▫ neoplastic disease in the cervical region, McReynolds and Sheridan • Original Contribution JAOA • Vol 105 • No 2 • February 2005 • 59
ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Pain Intensity Scores on 11-point Numerical Rating Scale (Pre- and Posttreatment) (N=58)
Osteopathic Manipulative
Ketorolac Group* (n=29)
Treatment Group† (n=29)
P
* Within the ketorolac group, PϽ.001 (95% CI, 1.1–2.3).
† Within the osteopathic manipulative treatment group, PϽ.001 (95% CI, 2.1–3.4).
‡ Posttreatment score was requested from patients at one hour after treatment.
Acute Neck Pain in the Emergency Department:
Pain Relief Scores on a 5-point Pain Relief Scale* (N=58)
Osteopathic Manipulative
Ketorolac Group (n=29)
Treatment Group (n=29)
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
* Within both study groups, for subjects receiving pain relief at one hour after treatment, P= .10.
▫ ossification of the posterior longitudinal ligament, heads and necks through range of motion tests (ie, for flexion, extension, side bending, and rotation) to determine any addi- tional areas of somatic dysfunction.
Osteopathic manipulative techniques performed included Patients with a history of nontraumatic neck pain and no a combination of HVLA thrust, muscle energy, and soft tissue clinical indications did not receive radiographs prior to study techniques.19 One or more OM techniques were used to opti- enrollment. Because pain scores are subjective, no minimum mize the treatment’s therapeutic benefits. The specific combi- score was required for study inclusion.
nation of the three OM techniques used was left to the dis- All patients received an initial structural exam. Enrolling cretion of the enrolling physician and was based on patients’ physicians palpated the cervical region to assess patients for needs, as assessed by the physician.
tissue texture changes, joint restrictions, and areas of tender- Intervention with OMT lasted less than 5 minutes and ness. In addition, enrolling physicians examined patients’ was completed by the enrolling physician.
60 • JAOA • Vol 105 • No 2 • February 2005
McReynolds and Sheridan • Original Contribution ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Patients With Prior Use of Nonsteroidal Anti-inflammatory Drugs
Pain Intensity Scores on 11-point Numerical Rating Scale (Pre- and Posttreatment) (N=18)
Osteopathic Manipulative
Ketorolac Group* (n=7)
Treatment Group† (n=11)
P
* Within the ketorolac group, P=.03 (95% CI, 0.3–4.1).
† Within the osteopathic manipulative treatment group, PϽ.01 (95% CI, 1.0–3.6).
‡ Posttreatment score was requested from patients at one hour after treatment.
Acute Neck Pain in the Emergency Department:
Patients With Prior Use of Nonsteroidal Anti-inflammatory Drugs
Pain Relief Scores on a 5-point Pain Relief Scale* (N=18)
Osteopathic Manipulative
Ketorolac Group (n=7)
Treatment Group (n=11)
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
* Within both study groups, for subjects receiving pain relief at one hour after treatment, P=.69.
For patients receiving pain management with We decided to have patients reassess pain intensity at one IM ketorolac, an order for 30 mg was given by the enrolling hour to allow the ketorolac sufficient time to reach peak plasma physician and administered by the nursing staff.
concentration and to observe patients for side effects.21,22 Patients were asked to use the 11-point Numerical Rating When asking patients to reassess their pain intensity levels Scale (NRS-11)20,21 to evaluate their perceived pain intensity at one hour after treatment, we hoped to avoid carry-over immediately prior to treatment and again at one hour post- bias and, therefore, did not allow patients to view the pre- treatment. Patients were given the following instructions, first vious pain intensity scores they provided immediately prior verbally and then in print, for rating the intensity of their pain: to treatment. Additionally, enrolling physicians were not On a pain scale from zero (0) to ten (10), with zero (0) allowed to look at the results of self-evaluated patient pain being no pain, and ten (10) being the worst pain you’ve intensity scores (a cover sheet was provided) or to ask patients ever had, how much pain do you feel right now? verbally how they had rated their level of pain intensity.
Please write your pain level on the line provided.
Patients were also asked to use a descriptive 5-point Pain McReynolds and Sheridan • Original Contribution JAOA • Vol 105 • No 2 • February 2005 • 61
ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Patients With No Prior Use of Nonsteroidal Anti-inflammatory Drugs
Pain Intensity Scores on 11-point Numerical Rating Scale (Pre- and Posttreatment) (N=40)
Osteopathic Manipulative
Ketorolac Group* (n=22)
Treatment Group† (n=18)
P
* Within the ketorolac group, PϽ.001 (95% CI, 1.0–2.2).
† Within the osteopathic manipulative treatment group, PϽ.001 (95% CI, 2.3–3.8).
‡ Posttreatment score was requested from patients at one hour after treatment.
Acute Neck Pain in the Emergency Department:
Patients With No Prior Use of Nonsteroidal Anti-inflammatory Drugs
Pain Relief Scores on a 5-point Pain Relief Scale* (N=40)
Osteopathic Manipulative
Ketorolac Group (n=22)
Treatment Group (n=18)
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
* Within both study groups, for subjects receiving pain relief at one hour after treatment, P=.01.
Relief Scale (PRS-5) to evaluate their perceived pain relief at one were used to compare the two study groups for differences in hour posttreatment. They were instructed to circle the letter next age and in the pre-to-post pain intensity changes reported by to the best description of the amount of relief they had since patients’ subjective measures. Comparisons on the PRS-5 scale receiving treatment: A, No Relief; B, Some Relief; C, Mod- were tested using the Mantel-Haenszel ␹2 test for trend. The erate Amount of Relief; D, A Lot of Relief; E, Complete Relief.
correlations were tested using the Spearman rank-order cor- We estimated a decrease in pain scores of 1.4 (20%) or relation. Testing was performed using the .05 ␣ level. The sta- greater to be clinically significant. A sample size of 58 total tistical package used for data analysis was Statistical Anal- patients provided an 80% chance (power) of detecting an ysis System software (Version 8.2, SAS Institute Inc, Cary, NC).
improvement in pain of 20% when tested at the .05 ␣ level.
Pearson’s ␹2 test was used to test for differences between the OMT group and the ketorolac group with respect to categor- A total of 58 patients were enrolled as subjects in this study.
ical demographic and comorbid variables. Two-tailed t tests Twenty-nine patients were placed in each of the two study 62 • JAOA • Vol 105 • No 2 • February 2005
McReynolds and Sheridan • Original Contribution ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Patients With Prior Use of Manipulation
Pain Intensity Scores on 11-point Numerical Rating Scale (Pre- and Posttreatment) (N=8)
Oseopathic Manipulative
Ketorolac Group* (n=5)
Treatment Group† (n=3)
P
* Within the ketorolac group, PϽ.01 (95% CI, 0.9–2.3).
† Within the osteopathic manipulative treatment group, P=.03 (95% CI, 0.8–6.5).
‡ Posttreatment score was requested from patients at one hour after treatment.
Acute Neck Pain in the Emergency Department:
Patients With Prior Use of Manipulation
Pain Relief Scores on a 5-point Pain Relief Scale* (N=8)
Osteopathic Manipulative
Ketorolac Group (n=5)
Treatment Group (n=3)
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
* Within both study groups, for subjects receiving pain relief at one hour after treatment, P=.03.
groups. Baseline subject characteristics were similar among icant decrease in self-reported pain intensity (Pϭ.02 [95% CI, the subjects enrolled in each study group; most patients had 0.2–1.9]). When comparing perceived pain relief at one hour, less than one day of acute neck pain before presenting to the there was no significant difference between the OMT and ED. The majority of patients (58%) had cervical strain resulting from a motor vehicle collision (Table 1).
Eighteen patients reported taking NSAIDs in the 24 hours Patients’ pain intensity scores recorded before treatment before seeking treatment in the ED. Among these 18 subjects, and one hour after treatment and their perceived pain relief at there was no statistically significant difference between subjects one hour posttreatment (PRS-5) are summarized in Tables 2 and in the ketorolac and OMT groups in decrease of pain intensity 3. Both groups had similar baseline pain intensity scores and at one hour after treatment (Pϭ.95 [95% CI, Ϫ2.1 to 1.9]) showed clinically significant improvement in subjective pain (Table 4). Similarly, among these 18 patients there was no sta- intensity measures (NRS-11) one hour after treatment. How- tistically significant difference when they were asked to report ever, patients in the OMT group showed a statistically signif- pain relief at one hour after treatment (Pϭ.69) (Table 5). How- McReynolds and Sheridan • Original Contribution JAOA • Vol 105 • No 2 • February 2005 • 63
ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Patients With No Prior Use of Manipulation
Pain Intensity Scores on 11-point Numerical Rating Scale (Pre- and Posttreatment) (N=50)
Oseopathic Manipulative
Ketorolac Group* (n=24)
Treatment Group† (n=26)
P
* Within the ketorolac group, PϽ.001 (95% CI, 1.0–2.5).
† Within the osteopathic manipulative treatment group, PϽ.001 (95% CI, 2.0–3.3).
‡ Posttreatment score was requested from patients at one hour after treatment.
Acute Neck Pain in the Emergency Department:
Patients With No Prior Use of Manipulation
Pain Relief Scores on a 5-point Pain Relief Scale* (N=50)
Osteopathic Manipulative
Ketorolac Group (n=24)
Treatment Group (n=26)
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
* Within both study groups, for subjects receiving pain relief at one hour after treatment, P=.37.
ever, as noted, these 18 subjects demonstrated a statistically sig- criteria, potential subjects were excluded from this study if nificant decrease in pain intensity scores (Table 4).
they received manipulation to treat the current incident of Osteopathic manipulative treatment was more effective pain.) Those who had previously received manipulation than ketorolac for decreasing pain levels reported among the demonstrated statistically significant decreases in pain inten- remaining 40 patients who had not taken NSAIDs within the sity scores, with OMT outperforming ketorolac (Pϭ.01 [95% CI, past 24 hours—as demonstrated in both subjective pain mea- 0.6–3.5]) (Table 8). The difference in reported pain relief at one sures (NRS-11: PϽ.01 [95% CI, 0.6–2.4]; PRS-5: Pϭ.01) (Tables 6 hour was also in favor of the OMT group with all three in that group having reported receiving “A Lot of Relief” as a Few patients in either study group had previously result of intervention with OMT (Pϭ.03) (Table 9).
received manipulation. Five patients in the ketorolac group and Patients in both study groups who had not previously three patients in the OMT group reported having received been treated with manipulation reported decreased pain with manipulation before this study. (As noted in the exclusion both ketorolac and OMT. Neither the difference reported in 64 • JAOA • Vol 105 • No 2 • February 2005
McReynolds and Sheridan • Original Contribution ORIGINAL CONTRIBUTION
Acute Neck Pain in the Emergency Department:
Correlation of Pain Relief Scores and Posttreatment Pain Intensity Scores
for Both Study Groups at One Hour After Treatment (N=58)
Posttreatment
Total Change
A – No Relief
B – Some Relief
C – Moderate Amount of Relief
D – A Lot of Relief
E – Complete Relief
pain intensity scores nor in pain relief scores was statistically not surprising that one is significant while the other is not.
significant between study groups (Pϭ.07 [95% CI, Ϫ1.9 to 0.1] Since the pain relief scale has only ordinal scale variables, one and Pϭ.37, respectively) (Tables 10 and 11).
would expect it to be less sensitive.
Self-reported pain scores after treatment on both subjec- Neither age, gender, nor etiology of pain appeared to sig- tive scales have a statistically significant correlation (␳ϭ0.7; nificantly confound the results. Study subjects who received PϽ.001). The difference between the pre- and posttreatment manipulation in the past showed a greater decrease in pain pain intensity scores (NRS-11) was also found to be significantly intensity and improved pain relief with OMT than with correlated with the pain relief scores (PRS-5) at one hour after ketorolac. We can speculate that patients may have learned to treatment (␳ϭ0.7; PϽ.001) (Table 12).
expect more from manipulation if they had a positive experi- After group assignment, attempts were not made within ence in the past. This may explain why this subgroup had a the study design to prevent the patient or physician from more favorable outcome with OMT than with IM ketorolac. It knowing which type of treatment was being given. Since is difficult to draw any definite conclusions, however, since patients completed the outcome measures, the value of a patient numbers were small for these subgroups.
blinded evaluation is limited. Although a placebo arm was In an attempt to represent the true population, patients not used, most patients were unfamiliar with manipulation; as were not excluded from this study if they had taken NSAIDs noted, eight patients had previously received manipulation, but in the 24 hours before they presented to the ED. Bartfield et al16 no patient had received manipulation for the current episode found that subjective pain score reduction was not signifi- cantly affected by recent use of NSAIDs, nor with concurrent Adverse effects for these two treatment modalities were use of muscle relaxants. Our study did not show significant dif- minimal for both groups. Within the ketorolac group, eight ferences between pain intensity scores for those who had taken patients cited one or more of the following adverse effects: NSAIDs within the past 24 hours. Interestingly, patients who arm soreness, bad taste in mouth, dizziness, drowsiness, dys- had not taken NSAIDs before presenting to the ED showed pepsia, heart racing, lightheadedness, nausea, or vomiting. In more improvement in pain levels when treated with OMT the OMT group, one patient stated that her arm felt “funny” rather than with IM ketorolac. A larger group of patients and after manipulation but that she had normal muscle strength, an additional test arm combining medication and OMT would sensation, and deep tendon reflexes. No further adverse effects be required to clarify any increased efficacy of the combination were observed for this patient while she was in the ED.
of these modalities, however. Previous studies have suggestedthat patients do better with this combination.23,24 Multiple studies have evaluated manual therapy for neck The results of this study suggest that OMT is significantly pain13,23-39 but only four studies have investigated acute neck better than IM ketorolac in decreasing pain intensity and that pain and only mobilization techniques were used in those it is as efficacious as IM ketorolac in providing pain relief for studies.40-43 Mobilization for acute neck pain may be benefi- patients with acute neck pain in the ED. Both study groups cial for some patients when used in combination with showed significant decreases in pain intensity, but there was other treatments.7,8 A single intervention with manipulation no significant difference between the groups’ self-reported has been shown to decrease neck pain.23,24,29,44 Our pain relief levels at one hour after treatment. The two subjec- results are consistent with prior studies in the observa- tive scales were correlated, although not perfectly, and it is tion that patients may receive immediate improvement McReynolds and Sheridan • Original Contribution JAOA • Vol 105 • No 2 • February 2005 • 65
ORIGINAL CONTRIBUTION
in pain with a single intervention with manipulation.
The true incidence of complications from OMT is It was not possible to blind the patients or physicians to unknown since reporting is only in the form of case reports, a study treatment protocols. After study enrollment, partici- case control study, and surveys. Complications have been pating patients were informed they were receiving either attributed to cervical manipulation with rotational technique, manipulation or an intramuscular injection of ketorolac. As misdiagnosis, failure to recognize the onset or progression of noted, enrolling physicians enrolled and treated all study sub- neurological signs or symptoms, and the presence of jects. Although patients may be partially blinded by including coagualopathies.2,45,46 Mild to moderate transient adverse reac- naïve patients (ie, those with no previous experience with the tions may occur in about 50% of patients after chiropractic treatment under study),52 we did not exclude patients with spinal manipulation.47 Vick et al46 found that 20% of injuries prior manipulation to gain a better representation of the pop- reported to have occurred when “manipulation” was the treat- ulation. Physicians may have been partially blinded if they ment modality used, and the therapy was provided by had not enrolled and treated each patient. However, this study someone other than an osteopathic physician, chiropractor, protocol was not feasible at our institutions and, therefore, or “qualified physician.” Cerebrovascular accidents account for introduced an increased likelihood of examiner bias.
66% of reported injuries after manipulation and 90% of deaths.46 Neither a placebo nor sham treatment was employed.
The incidence of stroke after neck manipulation has been esti- Authors of some studies have argued that “sham manipula- mated to be from 0.5 to 2 incidents per million manipula- tion” is impractical.53,54 Any therapeutic effect observed, they assert, may be attributed to the powerful psychological placebo A nested case control study by Rothwell et al49 revealed effect of the “laying-on-of-hands.”5,55-57 We believe that no that for every 100,000 persons younger than 45 years receiving sham treatment could be demonstrably “invalid” while at the chiropractic care, approximately 1.3 cases of vertebral basilar same time appearing valid to patients. A structural exam was accidents (VBA) attributable to chiropractic care would be included in both arms of the study protocol and may have observed within 1 week of treatment. Although attempts have resulted in a placebo or an active response. This active response been made to relate VBA to manipulation, the literature does may have reduced the possibility of attributing a difference not clearly identify patients at risk nor define the type of where none exists (type I error) to treatment with OMT.
mechanical trauma—neck movement or manipulative tech- The current dosing recommendations for IM ketorolac nique—which may precipitate vertebrobasilar artery dissec- in the United States are 30 mg to 60 mg, with the lowest dose recommended for patients aged to 65 years, patients who are Nonsteroidal anti-inflammatory drugs are generally con- renally impaired, and patients weighing less than 50 kg.51 Effi- sidered safe, but mild adverse effects may include: gastroin- cacy ratings between 30 mg and 90 mg of ketorolac have been testinal pain, diarrhea, dyspepsia, or nausea (7%–13%); con- comparable.58-61 There is no published data that suggests that stipation, flatulence, gastrointestinal “fullness,” vomiting, or ketorolac, 60 mg, is superior to 30 mg.62 We chose 30 mg, stomatitis (1%–3%); anorexia, gastritis, increased appetite, or ketorolac injected intramuscularly since we felt it was felt pru- rectal bleeding (Ͻ1%).51 Serious complications such as gas- dent to prescribe ketorolac at the lowest dosage necessary to trointestinal bleeding, gastrointestinal perforation, or renal control pain and minimize adverse effects.63,64 It is possible failure are rare. Dabbs and Lauretti48 evaluated the risk of that our patients did not get an optimal response with 30 mg, serious injury or death resulting from cervical manipulation however, and may have reported more positive subjective compared with NSAIDs and concluded that cervical manip- ulation for neck pain is much safer than the use of NSAIDs. Of Our outcome measure of pain relief was subjective. It can the 1500 patients reported in clinical trials of manipulation, no be argued that some objective means (eg, range of motion testing) should have also been used in evaluating treatment effi- In the current study, we found a relatively high incidence cacy. However, physiologic measures do not always reflect (27%) of adverse effects associated with IM ketorolac. Only one how patients feel,65 and disassociations among treatment out- patient in the OMT group reported an adverse effect, and it was comes have been documented in several studies.66 minor with no serious complications. Although our study and Additionally, we did not record refusal rates. Our results previous trials are encouraging in that they did not present may be skewed toward more positive results since those severe complications, it would be incorrect to deem cervical enrolled may have desired manipulation or intramuscular manipulation as completely benign and risk free; large con- injection. Patients who did not want either manipulation or an trolled studies are needed to determine risks and true inci- IM injection were free to exclude themselves as potential study This study was limited by the lack of blinding of the Using a convenience sample of patients also introduces patient or physician to treatment, no use of placebo, the selection bias. If alternate sampling methods had been used (eg, use of subjective measures to evaluate pain intensity levels random sampling), study results may have been strength- and relief, no tracking of refusal rates, convenience sampling, ened. In addition, less time may have been required to com- 66 • JAOA • Vol 105 • No 2 • February 2005
McReynolds and Sheridan • Original Contribution ORIGINAL CONTRIBUTION
13. Hoving JL, Koes BW, de Vet HC, van der Windt DA, Assendelft WJ,
plete the study. The use of random sampling methods was not Mameren H, et al. Manual therapy, physical therapy, or continued care by a a feasible option for the current study, however.
general practitioner for patients with neck pain. A randomized, controlled trial.
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14. Koenig KL, Hodgson L, Kozak R, Jordan K, Sexton TR, Leiken AM.
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