Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial

OBJECTIVES: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. STUDY DESIGN: Prospective, observer-blinded, pilot randomized clinical trial. SETTING: Primary contact chiropractic and medical clinics. PATIENTS: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica). OUTCOME MEASURES: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. The measures included leg and back pain severity, frequency and bothersomeness of symptoms, leg/back disability, medication use, global improvement, satisfaction, and health care utilization. INTERVENTIONS: Medical care, chiropractic care, and epidural steroid injections. RESULTS: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients were randomized into the study. All 3 groups showed substantial improvements in the main patient-rated outcomes at the end of the 12-week intervention phase. For leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score, the percent improvement varied from 50% to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bothersomeness of leg symptoms was the most responsive outcome associated with the largest magnitude of effect size. All within-group changes from baseline were statistically significant (P <.01). No between-group comparisons were planned or performed because of the insufficient sample size and high risk of committing type I and type II errors. CONCLUSIONS: Pilot studies such as these are important for the determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible, given the methods used in this pilot study. Our results do indicate, however, that there are substantial numbers of patients with sciatica more chronic in nature who would be interested in participating in a similar study. In addition, collaboration with a local health maintenance organization would likely facilitate clinician referrals and optimize the recruitment process. Patient and provider compliance was high in the pilot study, which indicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care use. A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 4 weeks duration has been planned before a full-scale trial is attempted.     

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.     

Effect of chiropractic intervention on small scoliotic curves in younger subjects: a time-series cohort design

BACKGROUND: Chiropractors have long claimed to affect scoliotic curves, and case studies abound reporting on successful outcomes. No clinical trials exist, however, that evaluate chiropractic's effectiveness in the management of scoliotic curves. OBJECTIVE: To assess the effectiveness of chiropractic intervention in the management of adolescent idiopathic scoliosis in curves less than 20 degrees. DESIGN: Cohort time-series trial with all subjects electing chiropractic care. Entry-level Cobb angle was compared with postmanagement curve. METHODS: Forty-two subjects completed the program of chiropractic intervention. Age range at entry was 6 to 12 years, and patients were included if their entry-level x-ray films revealed curves of 6 degrees to 20 degrees. Participants had adjustments performed for 1 year before follow-up. Full-spine osseous adjustments were the major form of intervention, but heel lifts and postural and lifestyle counseling were used as well. RESULTS: There was no discernable effect on the severity of the curves as a function of age, initial curve severity, frequency of care, or attending physician. CONCLUSION: Full-spine chiropractic adjustments with heel lifts and postural and lifestyle counseling are not effective in reducing the severity of scoliotic curves.     

A randomized controlled trial of chiropractic spinal manipulative therapy for migraine

OBJECTIVE: To assess the efficacy of chiropractic spinal manipulative therapy (SMT) in the treatment of migraine. DESIGN: A randomized controlled trial of 6 months' duration. The trial consisted of 3 stages: 2 months of data collection (before treatment), 2 months of treatment, and a further 2 months of data collection (after treatment). Comparison of outcomes to the initial baseline factors was made at the end of the 6 months for both an SMT group and a control group. Setting: Chiropractic Research Center of Macquarie University. PARTICIPANTS: One hundred twenty-seven volunteers between the ages of 10 and 70 years were recruited through media advertising. The diagnosis of migraine was made on the basis of the International Headache Society standard, with a minimum of at least one migraine per month. INTERVENTIONS: Two months of chiropractic SMT (diversified technique) at vertebral fixations determined by the practitioner (maximum of 16 treatments). MAIN OUTCOME MEASURES: Participants completed standard headache diaries during the entire trial noting the frequency, intensity (visual analogue score), duration, disability, associated symptoms, and use of medication for each migraine episode. RESULTS: The average response of the treatment group (n = 83) showed statistically significant improvement in migraine frequency (P < .005), duration (P < .01), disability (P < .05), and medication use (P< .001) when compared with the control group (n = 40). Four persons failed to complete the trial because of a variety of causes, including change in residence, a motor vehicle accident, and increased migraine frequency. Expressed in other terms, 22% of participants reported more than a 90% reduction of migraines as a consequence of the 2 months of SMT. Approximately 50% more participants reported significant improvement in the morbidity of each episode. CONCLUSION: The results of this study support previous results showing that some people report significant improvement in migraines after chiropractic SMT. A high percentage (>80%) of participants reported stress as a major factor for their migraines. It appears probable that chiropractic care has an effect on the physical conditions related to stress and that in these people the effects of the migraine are reduced.     

Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study

OBJECTIVE: To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. DESIGN: Randomized controlled-comparison trial with 3 parallel groups. SETTING: Private practice outpatient chiropractic clinic. PATIENTS: Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. INTERVENTIONS: Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. MAIN OUTCOME MEASURES: Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. RESULTS: Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0.1) in the no treatment control group. At the end of the study period, this change was -6.3 (95% CI: 13.1, 0.4), -1.0 (95% CI: -7.5, 15.6), -7.2 (95% CI: -13.3, -1.1) in the 3 study groups. The mean improvements in the chiropractic care and no treatment control groups remained consistent over the follow-up period. CONCLUSIONS: This pilot study elucidated several procedural issues that should be addressed before undertaking a full-scale clinical trial on the effects of chiropractic adjustments in patients with essential hypertension. A multidisciplinary approach to recruitment may need to be used in any future efforts because of the limited subject pool of patients who have hypertensive disease but are not taking medications for its control. Measures need to be used to assure comparable groups regarding prognostic variables such as weight. Studies such as these demonstrate the feasibility of conducting a full-scale 3-group randomized clinical trial in the private practice setting.     

Therapeutic outcomes monitoring by community pharmacists for improving clinical outcomes in asthma

OBJECTIVE: To determine the effect of enhanced therapeutic monitoring by community pharmacists on clinical outcomes of a convenience sample of asthma patients. METHODS: A one-year intervention study with scheduled visits and follow-ups at baseline, 4, 8, 12 and 24 months using a pre/post-test design, with a small convenience sample of 28 study patients, who performed their own controls. Outcomes measured were the severity of asthma symptoms, changes in the number of patients having peak expiratory flow (PEF) values below 85% or 70% of the optimal, changes in daily asthma medication and number of patients needing courses of oral steroids. RESULTS: A positive change was noticed in all the measures used, most clearly in the severity of asthma symptoms. During the intervention, mean scores of three out of five symptom measures improved significantly. Twenty-two (79%) patients had a net improvement in one or more asthma symptom indicators. The number of patients with PEF values below 85% of the optimal decreased from seven to four at 12 months. The number of patients having courses of oral steroids for asthma decreased. More than half (57%) of the patients had changes in their daily asthma medication. The effects lasted partly over one year after the intervention. CONCLUSIONS: The results of this study suggest that pharmacist intervention can have a positive effect on clinical outcomes of asthma patients. The results need to be confirmed with a study using a randomized controlled design.     

Development, implementation, and evaluation of a community pharmacy-based asthma care model

BACKGROUND: Pharmacists are uniquely placed in the healthcare system to address critical issues in asthma management in the community. Various programs have shown the benefits of a pharmacist-led asthma care program; however, no such programs have previously been evaluated in Australia. OBJECTIVE: To measure the impact of a specialized asthma service provided through community pharmacies in terms of objective patient clinical, humanistic, and economic outcomes. METHODS: A parallel controlled design, where 52 intervention patients and 50 control patients with asthma were recruited in 2 distinct locations, was used. In the intervention area, pharmacists were trained and delivered an asthma care model, with 3 follow-up visits over 6 months. This model was evaluated based on clinical, humanistic, and economic outcomes compared between and within groups. RESULTS: There was a significant reduction in asthma severity in the intervention group, 2.6 +/- 0.5 to 1.6 +/- 0.7 (mean +/- SD; p < 0.001) versus the control group, 2.3 +/- 0.7 to 2.4 +/- 0.5. In the intervention group, peak flow indices improved from 82.7% +/- 8.2% at baseline to 87.4% +/- 8.9% (p < 0.001) at the final visit, and there was a significant reduction in the defined daily dose of albuterol used by patients, from 374.8 +/- 314.8 microg at baseline to 198.4 +/- 196.9 microg at the final visit (p < 0.015). There was also a statistically significant improvement in perceived control of asthma and asthma-related knowledge scores in the intervention group compared with the control group between baseline and the final visit. Annual savings of $132.84(AU) in medication costs per patient and $100,801.20 for the whole group, based on overall severity reduction, were demonstrated. CONCLUSIONS: Based on the results of this study, it appears that a specialized asthma care model offers community pharmacists an opportunity to contribute toward improving asthma management in the Australian community.     

One-year follow-up of a randomized clinical trial comparing flexion distraction with an exercise program for chronic low-back pain

OBJECTIVE: Flexion distraction is a commonly used form of chiropractic care with chiropractor utilization rates of 58%. However, no previous randomized clinical trial has assessed the effectiveness of this form of care. The objective of this investigation was to compare the pain and disability during the year after active care based on treatment group allocation (Flexion Distraction versus Exercise Program). STUDY DESIGN: Randomized clinical trial, follow-up. SUBJECTS: Two hundred and thirty-five (235) subjects who were previously randomized to either chiropractic care (flexion distraction) or physical therapy (exercise program) within a clinical trial. OUTCOME MEASURES: Subjects were followed for 1 year via mailed questionnaires to assess levels of pain (Visual Analog Scale) and dysfunction (Roland Morris). RESULTS: Study subjects had a decrease in pain and disability after intervention regardless of which group they attended (p < 0.002), however, during the year after care, subjects who received chiropractic care (flexion distraction therapy) had significantly lower pain scores than subjects who received physical therapy (exercise program) (p = 0.02). CONCLUSIONS: In this first trial on flexion distraction care, flexion distraction was found to be more effective in reducing pain for 1 year when compared to a form of physical therapy.     

Regional Lumbar Motion and Patient-Rated Outcomes: A Secondary Analysis of Data From a Randomized Clinical Trial

ObjectiveThe purpose of this study was to examine the relationship in change scores between regional lumbar motion and patient-rated pain of the previous week and back-related function in chronic low back pain patients enrolled in a randomized clinical trial and treated with either exercise therapy or spinal manipulation using 6 different motion parameters.MethodsRegional lumbar motions were sampled using a 6 degrees of freedom instrumented spatial linkage system in 199 participants at baseline and 12-week follow-up. The regional lumbar motion data were analyzed as a total cohort as well as relative to subgroup stratifications; back pain only vs back and leg pain, and treatment modality. For identifying clinically meaningful improvements in the measurements of back pain and back-related function, we used a 30% threshold.ResultsThe relationship between change scores in patient-rated outcomes and objective measures of regional lumbar motion was found to be weak. In contrast, distribution of pain and treatment received affected associations between motion parameters and patient-rated outcomes. Thus, stronger correlation coefficients and significant differences between clinically relevant improved vs no clinical relevant change were found in some motion parameters in the subgroup with back pain only and the treatment group receiving spinal manipulation.ConclusionOverall, changes in regional lumbar motion were poorly associated with patient-rated outcomes measured by back-related function and back pain intensity scores. However, associations between regional lumbar motion vs patient-rated pain and back-related function were different in relative subgroups (back pain only vs back and leg pain and treatment).     

Patient characteristics, practice activities, and one-month outcomes for chronic, recurrent low-back pain treated by chiropractors and family medicine physicians: a practice-based feasibility study

BACKGROUND: Chronic low-back pain is a significant public health problem for which few therapies are supported by predictable outcomes. In this report, practice activities and 1-month outcomes data are presented for 93 chiropractic patients and 45 medical patients with chronic, recurrent low-back pain. DESIGN: A prospective, observational, community-based feasibility study involving chiropractors and family medicine physicians. SETTING: Forty private chiropractic clinics, the outpatient clinic of the Department of Family Medicine at Oregon Health Sciences University, and 5 other Portland area family medicine clinics. Outcomes Measures: The main outcome measures were pain severity, functional disability, sensory and affective pain quality at 1 month, and patient satisfaction assessed at 7 to 10 days and at 1 month. RESULTS: Although differences were noted in age, sex, education, and employment, the patients were closely matched at baseline with respect to frequency, severity, and type of low-back pain and the psychosocial dimensions of general health. The treatment of choice for chiropractors was spinal manipulation and physical therapy modalities; for medical physicians antiinflammatory agents were most frequently used. Chiropractic patients averaged 4 visits, and medical patients averaged 1 visit. On average, chiropractic patients showed improvement across all outcomes: 31% change in pain severity, 29% in functional disability, 36% in sensory pain quality, and 57% in affective pain quality. Medical patients showed minimal improvement in pain severity (6%) and functional disability (1%) and showed deterioration in the sensory (29%) and affective (26%) dimensions of pain quality. Satisfaction scores were higher for chiropractic patients. Outcomes for medical patients were heavily dependent on psychosocial status at baseline. CONCLUSION: Patients with chronic low-back pain treated by chiropractors show greater improvement and satisfaction at 1 month than patients treated by family physicians. Nonclinical factors may play an important role in patient progress. Findings from the Health Resources and Services Administration-funded project will include a report on the influence of practice activities, including more frequent visits by chiropractic patients, on the clinical course of low-back pain and patient outcomes. (J Manipulative Physiol Ther 2000;23:239-45).     

Economic evaluation of four treatments for low-back pain: results from a randomized controlled trial

OBJECTIVE: We sought to compare total outpatient costs of 4 common treatments for low-back pain (LBP) at 18-months follow-up. METHODS: Our work reports on findings from a randomized controlled trial within a large medical group practice treating HMO patients. Patients (n = 681) were assigned to 1 of 4 treatment groups, ie, medical care only (MD), medical care with physical therapy (MDPt), chiropractic care only (DC), or chiropractic care with physical modalities (DCPm). Total outpatient costs, excluding pharmaceuticals, were measured at 18 months. We did not perform a cost-effectiveness analysis because previously published findings showed no clinically meaningful difference in outcomes among the 4 treatment groups. Thirty-seven participants were lost to follow-up at 18 months, leaving a final sample size of n = 654. RESULTS: Adjusting for covariates, DC was 51.9% more expensive than MD (P < 0.001), DCPm 3.2% more expensive than DC (P = 0.76), and MDPt 105.8% more expensive than MD (P < 0.001). The adjusted mean outpatient costs per treatment group were 369 US dollars for MD, 560 US dollars for DC, 579 US dollars for DCPm, and 760 US dollars for MDPt. CONCLUSIONS: This study is the first randomized trial to show higher costs for chiropractic care without producing better clinical outcomes, but our findings are likely to understate the costs of medical care with or without physical therapy because of the absence of pharmaceutical data. Physical therapy provided in combination with medical care and physical modalities provided in combination with chiropractic care do not appear to be cost-effective strategies for treatment of LBP; they produce higher costs without clinically significant improvements in outcome.     

Mechanical force spinal manipulation increases trunk muscle strength assessed by electromyography: a comparative clinical trial

OBJECTIVE: The objective of this study was to determine whether mechanical force, manually-assisted (MFMA) spinal manipulative therapy (SMT) affects paraspinal muscle strength as assessed through use of surface electromyography (sEMG). DESIGN: Prospective clinical trial comparing sEMG output in 1 active treatment group and 2 control groups. SETTING: Outpatient chiropractic clinic, Phoenix, AZ. SUBJECTS: Forty subjects with low back pain (LBP) participated in the study. Twenty patients with LBP (9 females and 11 males with a mean age of 35 years and 51 years, respectively) and 20 age- and sex-matched sham-SMT/control LBP subjects (10 females and 10 males with a mean age of 40 years and 52 years, respectively) were assessed. METHODS: Twenty consecutive patients with LBP (SMT treatment group) performed maximum voluntary contraction (MVC) isometric trunk extensions while lying prone on a treatment table. Surface, linear-enveloped sEMG was recorded from the erector spinae musculature at L3 and L5 during a trunk extension procedure. Patients were then assessed through use of the Activator Methods Chiropractic Technique protocol, during which time they were treated through use of MFMA SMT. The MFMA SMT treatment was followed by a dynamic stiffness and algometry assessment, after which a second or post-MVC isometric trunk extension and sEMG assessment were performed. Another 20 consecutive subjects with LBP were assigned to one of two other groups, a sham-SMT group and a control group. The sham-SMT group underwent the same experimental protocol with the exception that the subjects received a sham-MFMA SMT and dynamic stiffness assessment. The control group subjects received no SMT treatment, stiffness assessment, or algometry assessment intervention. Within-group analysis of MVC sEMG output (pre-SMT vs post-SMT sEMG output) and across-group analysis of MVC sEMG output ratio (post-SMT sEMG/pre-SMT sEMG output) during MVC was performed through use of a paired observations t test (POTT) and a robust analysis of variance (RANOVA), respectively. MAIN OUTCOME MEASURES: Surface, linear-enveloped EMG recordings during isometric MVC trunk extension were used as the primary outcome measure. RESULTS: Nineteen of the 20 patients in the SMT treatment group showed a positive increase in sEMG output during MVC (range, -9.7% to 66.8%) after the active MFMA SMT treatment and stiffness assessment. The SMT treatment group showed a significant (POTT, P < 0.001) increase in erector spinae muscle sEMG output (21% increase in comparison with pre-SMT levels) during MVC isometric trunk extension trials. There were no significant changes in pre-SMT vs post-SMT MVC sEMG output for the sham-SMT (5.8% increase) and control (3.9% increase) groups. Moreover, the sEMG output ratio of the SMT treatment group was significantly greater (robust analysis of variance, P = 0.05) than either that of the sham-SMT group or that of the control group. CONCLUSIONS: The results of this preliminary clinical trial demonstrated that MFMA SMT results in a significant increase in sEMG erector spinae isometric MVC muscle output. These findings indicate that altered muscle function may be a potential short-term therapeutic effect of MFMA SMT, and they form a basis for a randomized, controlled clinical trial to further investigate acute and long-term changes in low back function.     

Brief, computer-assisted diabetes dietary self-management counseling: effects on behavior, physiologic outcomes, and quality of life

OBJECTIVES: The objective of this work was to evaluate the reach, effectiveness, adoption, and implementation of a brief behavioral dietary intervention and 2 supplemental components of diabetes self-management support: telephone follow-up calls and community resources enhancement. DESIGN AND SUBJECTS: This was a 2 x 2 randomized, controlled trial investigating the incremental effects of telephone follow-up and community resources enhancement with 320 adult type 2 diabetes outpatients. METHODS. Key outcomes included behavioral (dietary patterns, fat intake), physiologic (HbA1c, lipids), and quality-of-life/patient satisfaction measures and were collected at baseline and 3- and 6-month follow-up. RESULTS: Despite high reach (76% patient participation), excellent adoption (all 12 primary care practices approached participated), and good implementation, there were few outcome differences among treatment conditions. There was significant improvement across conditions in most outcomes in each category at both follow-ups. CONCLUSIONS: A brief, computer-assisted, dietary goal-setting intervention basic treatment condition was moderately successful in producing dietary improvements but less so in producing biologic or quality-of-life outcomes. Additions of follow-up phone calls or a community resources enhancement component did not produce incremental improvements over this basic intervention.     

Chronic spinal pain syndromes: a clinical pilot trial comparing acupuncture, a nonsteroidal anti-inflammatory drug, and spinal manipulation.

OBJECTIVE: To compare needle acupuncture, medication (tenoxicam with ranitidine), and spinal manipulation for managing chronic (>13 weeks duration) spinal pain syndromes. DESIGN: Prospective, randomized, independently assessed preintervention and postintervention clinical pilot trial. SETTING: Specialized spinal pain syndrome out-patient unit at Townsville General Hospital, Queensland, Australia. SUBJECTS: Seventy-seven patients (without contraindication to manipulation or medication) were recruited. INTERVENTIONS: One of three separate, clearly defined intervention protocols: needle acupuncture, nonsteroidal anti-inflammatory medication, or chiropractic spinal manipulation. MAIN OUTCOME MEASURES: Main outcome measures were changes (4 weeks vs. initial visit) in the scores of the (1) Oswestry Back Pain Disability Index, (2) Neck Disability Index, and (3) three visual analogue scales of local pain intensity. RESULTS: Randomization was successful. After a median intervention period of 30 days, spinal manipulation was the only intervention that achieved statistically significant improvements (all expressed as percentages of the original scores) with (1) a reduction of 30.7% on the Oswestry scale, (2) an improvement of 25% on the neck disability index, and (3) reductions on the visual analogue scale of 50% for low back pain, 46% for upper back pain, and 33% for neck pain (all P<.001). Neither of the other interventions showed any significant improvement on any of the outcome measures. CONCLUSIONS: The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine.     

Back pain and satisfaction with chiropractic treatment: what role does the physical outcome play?

OBJECTIVES: This study sought to determine what functional and affective outcomes had the most predictive value for overall satisfaction and improvement in patients seeking chiropractic treatment of low back pain. METHOD: Baseline questionnaires were completed by 965 patients seeking chiropractic help for low back pain, with blinded follow-up at 6 weeks. Patients were asked about effects on pain, anxiety, normal activity, work, depression, lifestyle, satisfaction, and overall improvement. Stepwise multiple regression analyses were used to evaluate the contribution of change scores to overall improvement and satisfaction. A 2-stage block regression was conducted to find out what additional factors besides overall improvement predicted patient satisfaction. RESULTS: There were weak to moderate, but highly significant, relationships between the change scores and both improvement and satisfaction. However, most of the variance (57%) in the latter was explained by overall improvement and a very small amount (0.5%) by improvements in activity, leaving nearly 43% unexplained by any of the variables. Pain, work, and ability to control pain together predicted 27% of the variance in overall improvement. No other variables predicted this, leaving 73% of the variance unexplained. DISCUSSION: Pragmatic rather than affective variables played some part in predicting satisfaction through global improvement in these patients. This should help to inform future interpretation of clinical trials of chiropractic treatments for back pain. However, the nature of the "unknown" components needs further investigation. There are initial indications in the literature that information giving, and the reconfiguration of patients' perceptions of the problem, may contribute to patient satisfaction generally. Further work is needed to confirm this and to establish where such interventions can also contribute to overall improvement.     

A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments

OBJECTIVES: To evaluate the proposed manual placebo in terms of success in blinding patients to treatment group assignment and outcomes between the treatment groups. DESIGN: Randomized controlled trial. SETTING: A chiropractic college research clinic in the midwestern United States. SUBJECTS: One hundred and eleven (111) individuals aged 18 years and over with subacute or chronic lowback pain. INTERVENTIONS: The active treatment consisted of flexion-distraction chiropractic manipulation and trigger point therapy and the control treatment of sham manipulation and effleurage; both groups received eight treatments over a 3-week period. The application of prescribed ranges of biomechanical forces for each treatment was standardized using specialized computerized equipment. "Nontreatment" aspects of the clinical encounter were to be standardized across groups. A primary clinician blinded to treatment assignment provided interpersonal interactions and treating clinicians delivered treatments with a minimum of interaction. OUTCOME MEASURES: The accuracy of the patient's perception of group assignment at visit 4 and the mean change in the Pain Disability Index (PDI) over the treatment period were the primary outcome variables. RESULTS: Patients in the control group were more likely to perceive their treatment assignment accurately than those in the active group (78% versus 54%, respectively). Patients in both treatment groups improved on the PDI and the Roland-Morris Questionnaire; there were no significant differences in improvement between the groups. Age, gender, prior chiropractic experience and expectation of treatment at baseline had no effect on outcomes. CONCLUSIONS: Patients in the control group were not successfully blinded; however, patients' perceptions of treatment group assignment did not significantly affect outcomes. The clinically significant improvement in both groups, independent of patient or clinician expectations, suggests the presence of therapeutic factors common to both groups, other than biomechanical force. Further studies examining other aspects of the clinical encounter, considered separately from biomechanical force, are warranted before arbitrarily designating any intervention as a "placebo."     

Second Prize: The effectiveness of physical modalities among patients with low back pain randomized to chiropractic care: findings from the UCLA low back pain study

BACKGROUND: Although chiropractors often use physical modalities with spinal manipulation, evidence that modalities yield additional benefits over spinal manipulation alone is lacking. OBJECTIVE: The purpose of the study was to estimate the net effect of physical modalities on low back pain (LBP) outcomes among chiropractic patients in a managed-care setting. METHODS: Fifty percent of the 681 patients participating in a clinical trial of LBP treatment strategies were randomized to chiropractic care with physical modalities (n = 172) or without physical modalities (n = 169). Subjects were followed for 6 months with assessments at 2, 4, and 6 weeks and at 6 months. The primary outcome variables were average and most severe LBP intensity in the past week, assessed with numerical rating scales (0-10), and low back-related disability, assessed with the 24-item Roland-Morris Disability Questionnaire. RESULTS: Almost 60% of the subjects had baseline LBP episodes of more than 3 months' duration. The 6-month follow-up was 96%. The adjusted mean differences between groups in improvements in average and most severe pain and disability were clinically insignificant at all follow-up assessments. Clinically relevant improvements in average pain and disability were more likely in the modalities group at 2 and 6 weeks, but this apparent advantage disappeared at 6 months. Perceived treatment effectiveness was greater in the modalities group. CONCLUSIONS: Physical modalities used by chiropractors in this managed-care organization did not appear to be effective in the treatment of patients with LBP, although a small short-term benefit for some patients cannot be ruled out.     

Children's adherence to recommended asthma self-management

PURPOSE: Adherence to peak expiratory flow rate monitoring by children with asthma was evaluated, and a behavioral strategy to enhance adherence to daily monitoring was tested. DESIGN AND METHODS: Forty-two 7- through 11-year-old children with persistent asthma were recruited into a 5-week randomized, controlled clinical trial. Adherence data were collected electronically by PeakLog and the self-report Asthma Diary. RESULTS: Adherence declined over time. At week 5, intervention group adherence (Median = 79%) was higher than the usual care group adherence (Median = 64%), but the difference was not statistically significant. The effect size did suggest that differences between groups were present. CONCLUSIONS: Even small improvements in adherence to asthma treatment may be clinically significant in light of the alarming increases in asthma morbidity and mortality. Contingency management shows promise for improving adherence outcomes. Future research should engage larger sample sizes and increase the number and intensity of sessions to teach behavioral strategies.