A total of 58 patients were enrolled as subjects in this study. Twenty-nine patients were placed in each of the two study groups. Baseline subject characteristics were similar among the subjects enrolled in each study group; most patients had less than one day of acute neck pain before presenting to the ED. The majority of patients (58%) had cervical strain resulting from a motor vehicle collision (
Table 1).
Patients' pain intensity scores recorded before treatment and one hour after treatment and their perceived pain relief at one hour posttreatment (PRS-5) are summarized in
Tables 2 and
3. Both groups had similar baseline pain intensity scores and showed clinically significant improvement in subjective pain intensity measures (NRS-11) one hour after treatment. However, patients in the OMT group showed a statistically significant decrease in self-reported pain intensity (
P=.02 [95% CI, 0.2–1.9]). When comparing perceived pain relief at one hour, there was no significant difference between the OMT and ketorolac groups (
P=.10).
Eighteen patients reported taking NSAIDs in the 24 hours before seeking treatment in the ED. Among these 18 subjects, there was no statistically significant difference between subjects in the ketorolac and OMT groups in decrease of pain intensity at one hour after treatment (
P=.95 [95% CI, –2.1 to 1.9]) (
Table 4). Similarly, among these 18 patients there was no statistically significant difference when they were asked to report pain relief at one hour after treatment (
P=.69) (
Table 5). However, as noted, these 18 subjects demonstrated a statistically significant decrease in pain intensity scores (
Table 4).
Osteopathic manipulative treatment was more effective than ketorolac for decreasing pain levels reported among the remaining 40 patients who had not taken NSAIDs within the past 24 hours—as demonstrated in both subjective pain measures (NRS-11:
P<.01 [95% CI, 0.6–2.4]; PRS-5:
P=.01) (
Tables 6 and
7).
Few patients in either study group had previously received manipulation. Five patients in the ketorolac group and three patients in the OMT group reported having received manipulation before this study. (As noted in the exclusion criteria, potential subjects were excluded from this study if they received manipulation to treat the current incident of pain.) Those who had previously received manipulation demonstrated statistically significant decreases in pain intensity scores, with OMT outperforming ketorolac (
P=.01 [95% CI, 0.6–3.5]) (
Table 8). The difference in reported pain relief at one hour was also in favor of the OMT group with all three in that group having reported receiving “A Lot of Relief” as a result of intervention with OMT (
P=.03) (
Table 9).
Patients in both study groups who had not previously been treated with manipulation reported decreased pain with both ketorolac and OMT. Neither the difference reported in pain intensity scores nor in pain relief scores was statistically significant between study groups (
P=.07 [95% CI, –1.9 to 0.1] and
P=.37, respectively) (
Tables 10 and
11).
Self-reported pain scores after treatment on both subjective scales have a statistically significant correlation (ρ=0.7;
P<.001). The difference between the pre- and posttreatment pain intensity scores (NRS-11) was also found to be significantly correlated with the pain relief scores (PRS-5) at one hour after treatment (ρ=0.7;
P<.001) (
Table 12).
After group assignment, attempts were not made within the study design to prevent the patient or physician from knowing which type of treatment was being given. Since patients completed the outcome measures, the value of a blinded evaluation is limited. Although a placebo arm was not used, most patients were unfamiliar with manipulation; as noted, eight patients had previously received manipulation, but no patient had received manipulation for the current episode of pain.
Adverse effects for these two treatment modalities were minimal for both groups. Within the ketorolac group, eight patients cited one or more of the following adverse effects: arm soreness, bad taste in mouth, dizziness, drowsiness, dyspepsia, heart racing, lightheadedness, nausea, or vomiting. In the OMT group, one patient stated that her arm felt “funny” after manipulation but that she had normal muscle strength, sensation, and deep tendon reflexes. No further adverse effects were observed for this patient while she was in the ED.