SPINAL MANIPULATION VS AMITRIPTYLINE FOR THE TREATMENT OF CHRONIC TENSION-TYPE HEADACHES - A RANDOMIZED CLINICAL-TRIAL

Objective: To compare the effectiveness of spinal manipulation and pha rmaceutical treatment (amitriptyline) for chronic tension-type headach e. Design: Randomized controlled trial using two parallel groups. The study consisted of a 2-wk baseline period, a 6-wk treatment period and a 4-wk posttreatment, follow-up period. Setting: Chiropractic college outpatient clinic. Patients: One hundred and fifty patients between t he ages of 18 and 70 with a diagnosis of tension-type headaches of at least 3 months' duration at a frequency of at least once per wk. Inter ventions: 6 wk of spinal manipulative therapy provided by chiropractor s or 6 wk of amitriptyline treatment managed by a medical physician. M ain Outcome Measures: Change in patient-reported daily headache intens ity, weekly headache frequency, over-the-counter medication usage and functional health status (SF-36). Results: A total of 448 people respo nded to the recruitment advertisements; 298 were excluded during the s creening process. Of the 150 patients who were enrolled in the study, 24 (16%) dropped out: 5 (6.6%) from the spinal manipulative therapy an d 19 (27.1%) from the amitriptyline therapy group. During the treatmen t period, both groups improved at very similar rates in all primary ou tcomes. In relation to baseline values at 4 wk after cessation of trea tment, the spinal manipulation group showed a reduction of 32% in head ache intensity, 42% in headache frequency, 30% in over-the-counter med ication usage and an improvement of 16% in functional health status. B y comparison, the amitriptyline therapy group showed no improvement or a slight worsening from baseline values in the same four major outcom e measures. Controlling for baseline differences, all group difference s at 4 wk after cessation of therapy were considered to be clinically important and were statistically significant. Of the patients who fini shed the study, 46 (82.1%) in the amitriptyline therapy group reported side effects that included drowsiness, dry mouth and weight gain. Thr ee patients (4.3%) in the spinal manipulation group reported neck sore ness and stiffness. Conclusions: The results of this study show that s pinal manipulative therapy is an effective treatment for tension heada ches. Amitriptyline therapy was slightly more effective in reducing pa in at the end of the treatment period but was associated with more sid e effects. Four weeks after the cessation of treatment, however, the p atients who received spinal manipulative therapy experienced a sustain ed therapeutic benefit in all major outcomes in contrast to the patien ts that received amitriptyline therapy, who reverted to baseline value s. The sustained therapeutic benefit associated with spinal manipulati on seemed to result in a decreased need for over-the-counter medicatio n. There is a need to assess the effectiveness of spinal manipulative therapy beyond four weeks and to compare spinal manipulative therapy t o an appropriate placebo such as sham manipulation in future clinical trials.