A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children.

BACKGROUND: Pediatric otitis media with effusion is a common and costly condition. Although chiropractors have anecdotally claimed success in treating otitis media, there is little research to support their claims. OBJECTIVE: A pilot study was undertaken for the purpose of assessing the feasibility of conducting a full-scale randomized clinical trial investigating the efficacy of chiropractic spinal manipulative therapy (SMT) for children with chronic otitis media with effusion. METHODS: This study was a prospective, parallel-group, observer-blinded, randomized feasibility study. Twenty-two patients, ages 6 months to 6 years, received either active chiropractic SMT or placebo chiropractic SMT. Otoscopy and tympanometry were used to create a middle ear status profile, and daily diaries were collected. RESULTS: Five newspaper advertisements over 6 months generated 105 responses. Twenty patients subsequently qualified and were randomized into the study. Collection of tympanometric and otoscopic data proved to be challenging. Compliance with the treatment and evaluation protocols and daily diaries was excellent. There were no reports of serious side effects as a result of either the active or placebo chiropractic treatments. CONCLUSION: Recruitment for a randomized controlled trial is feasible and could be enhanced by medical collaboration. Patients and parents are able and willing to participate in a study comparing active SMT and placebo SMT. Parents were extremely compliant with the daily diaries, suggesting that similar quality-of-life and functional status measures can be successfully used in a larger trial. We found the objective outcomes assessment involving tympanometry and otoscopy extremely challenging and should be performed by experienced examiners in future studies.

The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headache.

BACKGROUND: Migraine headache affects approximately 11 million adults in the United States. Spinal manipulation is a common alternative therapy for headaches, but its efficacy compared with standard medical therapies is unknown. OBJECTIVE: To measure the relative efficacy of amitriptyline, spinal manipulation and the combination of both therapies for the prophylaxis of migraine headache. DESIGN: A prospective, randomized, parallel-group comparison. After a 4-wk baseline period, patients were randomly assigned to 8 wk of treatment, after which there was a 4-wk follow-up period. SETTING: Chiropractic college outpatient clinic. PARTICIPANTS: A total of 218 patients with the diagnosis of migraine headache. INTERVENTIONS: An 8-wk course of therapy with spinal manipulation, amitriptyline or a combination of the two treatments. MAIN OUTCOME MEASURES: A headache index score derived from a daily headache pain diary during the last 4 wk of treatment and during the 4-wk follow-up period. RESULTS: Clinically important improvement was observed in both primary and secondary outcomes in all three study groups over time. The reduction in headache index scores during treatment compared with baseline was 49% for amitriptyline, 40% for spinal manipulation and 41% for the combined group; p = .66. During the posttreatment follow-up period the reduction from baseline was 24% for amitriptyline, 42% for spinal manipulation and 25% for the combined group; p = .05. CONCLUSION: There was no advantage to combining amitriptyline and spinal manipulation for the treatment of migraine headache. Spinal manipulation seemed to be as effective as a well-established and efficacious treatment (amitriptyline), and on the basis of a benign side effects profile, it should be considered a treatment option for patients with frequent migraine headaches.

Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial.

OBJECTIVES: To study the relative efficacy of three different treatment for chronic low back pain (CLBP). Two preplanned comparisons were made: (a) Spinal manipulative therapy (SMT) combined with trunk strengthening exercises (TSE) vs. SMT combined with trunk stretching exercises, and (b) SMT combined with TSE vs. nonsteroidal anti-inflammatory drug (NSAID) therapy combined with TSE. STUDY DESIGN: Interdisciplinary, prospective, observer-blinded, randomized clinical trial with a 1-yr follow-up period. The trial evaluated therapies in combination only and was not designed to test the individual treatment components. SETTING: Primary contact, college out-patient clinic. PATIENTS: In total, 174 patients aged 20-60 yr were admitted to the study. MAIN OUTCOME MEASURES: Patient-rated low back pain, disability, and functional health status at 5 and 11 wk. INTERVENTIONS: Five weeks of SMT or NSAID therapy in combination with supervised trunk exercise, followed by and additional 6 wk of supervised exercise alone. RESULTS: Individual group comparisons after 5 and 11 wk of intervention on all three main outcome measures did not reveal any clear clinically important or statistically significant differences. There seemed to be a sustained reduction in medication use at the 1-yr follow-up. in the SMT/TSE group. Continuance of exercise during the follow-up year, regardless of type, was associated with a better outcome. CONCLUSION: Each of the three therapeutic regimens was associated with similar and clinically important improvement over time that was considered superior to the expected natural history of long-standing CLBP. For the management of CLBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial and worthwhile. The magnitude of nonspecific therapeutic (placebo) effects, cost-effectiveness and relative risks of side effects associated with these types of therapy need to be addressed in future studies.

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 pharmaceutical treatment (amitriptyline) for chronic tension-type headache. 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 the 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. INTERVENTIONS: 6 wk of spinal manipulative therapy provided by chiropractors or 6 wk of amitriptyline treatment managed by a medical physician. MAIN OUTCOME MEASURES: Change in patient-reported daily headache intensity, weekly headache frequency, over-the-counter medication usage and functional health status (SF-36). RESULTS: A total of 448 people responded to the recruitment advertisements; 298 were excluded during the screening process. Of the 150 patients who were enrolled in the study, 24 (16%) dropped out: 5 (6.6%) from the spinal manipulative therapy and 19 (27.1%) from the amitriptyline therapy group. During the treatment period, both groups improved at very similar rates in all primary outcomes. In relation to baseline values at 4 wk after cessation of treatment, the spinal manipulation group showed a reduction of 32% in headache intensity, 42% in headache frequency, 30% in over-the-counter medication usage and an improvement of 16% in functional health status. By comparison, the amitriptyline therapy group showed no improvement or a slight worsening from baseline values in the same four major outcome measures. Controlling for baseline differences, all group differences at 4 wk after cessation of therapy were considered to be clinically important and were statistically significant. Of the patients who finished the study, 46 (82.1%) in the amitriptyline therapy group reported side effects that included drowsiness, dry mouth and weight gain. Three patients (4.3%) in the spinal manipulation group reported neck soreness and stiffness. CONCLUSIONS: The results of this study show that spinal manipulative therapy is an effective treatment for tension headaches. Amitriptyline therapy was slightly more effective in reducing pain at the end of the treatment period but was associated with more side effects. Four weeks after the cessation of treatment, however, the patients who received spinal manipulative therapy experienced a sustained therapeutic benefit in all major outcomes in contrast to the patients that received amitriptyline therapy, who reverted to baseline values. The sustained therapeutic benefit associated with spinal manipulation seemed to result in a decreased need for over-the-counter medication. There is a need to assess the effectiveness of spinal manipulative therapy beyond four weeks and to compare spinal manipulative therapy to an appropriate placebo such as sham manipulation in future clinical trials.

Interexaminer reliability of eight evaluative dimensions of lumbar segmental abnormality: Part II.

OBJECTIVE: The objectives of this study were to assess the interexaminer agreement of palpation for soft tissue and osseous pain along with visual observations in the lumbar spine. Second, the interexaminer agreement of dermothermograph and surface electromyographic (EMG) scans of the lumbar spine were assessed. Third, to perform these evaluations on symptomatic low back patients. Finally, the most reliable measurements were combined in a multidimensional index of segmental lumbar abnormality, which was assessed for interexaminer agreement. DESIGN: This is an interexaminer reliability study of commonly used palpatory and instrumentation procedures used to assess lumbar segmental abnormality. SETTING: This study was conducted at Pain Assessment and Rehabilitation Center (PARC) and the Center for Clinical Studies (CCS) at Northwestern College of Chiropractic. PATIENTS: The patients involved in this study were symptomatic at the time of examination. The patients were recruited from the CCS clinic and PARC. RESULTS: Palpation for osseous pain produced kappa coefficients ranging from .48-.90. Palpation for soft tissue pain produced kappa coefficients that ranged from .40-.79 and the kappas for visual observation ranged from .34-.84. The dermothermograph and surface EMG scanner were also assessed with the kappa coefficient for their reliability in assessing lumbar segmental abnormality. The kappa coefficients ranged from -.13 to .59 for the surface EMG and 0- .63 for the dermothermograph measurements. Intraclass correlation coefficients for the surface EMG measurements ranged from .20-.55 and the dermothermograph measurements ranged from .01-.55. Palpation for pain (osseous and soft tissue) and visual observation were included in the multidimensional index of abnormality. The interexaminer agreement of detecting a manipulable lesion was evaluated by designating a lesion present with a positive two out of three tests. Kappa coefficients for the multidimensional index of lumbar abnormality ranged from a low of .05 to a high of .52. CONCLUSIONS: Palpation for pain (osseous and soft tissue) and visual observation produced good to excellent interexaminer agreement and were included in the multidimensional index of abnormality. The interexaminer agreement of surface EMG scans and dermothermograph measurements were poor and considered to be clinically unacceptable, thus were not included in the multidimensional index. Palpation for pain is the only spinal assessment procedure to show consistent reliability in a number of studies.

Interexaminer reliability and discriminant validity of inclinometric measurement of lumbar rotation in chronic low-back pain patients and subjects without low-back pain.

The interexaminer reliability of an inclinometer procedure to measure lumbar rotation was evaluated by two chiropractic clinicians who examined 25 chronic (greater than 6 months) low-back pain patients and 25 subjects without low-back pain. These groups were compared for differences in mean left, right, and total rotation. Patients who had lumbar spinal surgery were excluded. Twenty-eight men and 22 women, ranging in age from 28-38 years, were evaluated. Reliability between examiners was evaluated by Pearson's correlation coefficient and the intraclass correlation coefficient. All coefficients were significant (P less than 0.01). Errors in prediction and examiner disagreement were evaluated by the standard error of estimate and the interexaminer measurement error. The standard errors of estimate (range: 1.4-4.4) and the interexaminer measurement errors (range: 3.8-10.4) were large compared to the scale of measurement. An analysis of variance of differences between the chronic low-back pain patients and asymptomatics revealed significantly more left rotation in the asymptomatic subjects (F = 8.4; df = 1; P less than 0.006). Also, there was significantly more total rotation in the asymptomatic subjects (F = 4.143; df = 1; P less than 0.048). However, because of the large error attributed to this procedure, it is not possible to say whether the difference between the two groups is a result of the large error or some "real" difference. Therefore, the procedure described in this study should not be used as a clinical outcome measure.

Malignant schwannoma.

This paper reports a patient suffering from a malignant peripheral nerve sheath tumor, also known as a Schwannoma or neurilemoma. The patient demonstrated an increase in left thigh circumference, without apparent trauma. The report establishes the relationship of the lack of trauma and relatively mild symptomatology with malignant conditions, as well as the need for chiropractors to do thorough history, physical and radiological examinations. A brief review of pathophysiology and incidence is given.