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Biomedical subjects

J Michael Menke

Publications and source records attributed to J Michael Menke.

6 recordsLinked to original sources

Chiropractic manipulation in adolescent idiopathic scoliosis: a pilot study.

BACKGROUND: Adolescent idiopathic scoliosis (AIS) remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. METHODS: Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment), two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. RESULTS: Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. CONCLUSION: Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. TRIAL REGISTRATION: This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

Journal Article↗

Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.

STUDY DESIGN: A prospective cross-sectional design was used to evaluate the Scoliosis Quality of Life Index (SQLI). SQLI is a 22-item self-reporting health-related quality-of-life questionnaire for idiopathic scoliosis patients. OBJECTIVE: The goal of this study was to evaluate the psychometric qualities of SQLI. SUMMARY OF BACKGROUND DATA: SQLI, a modification of the Scoliosis Research Society-22 (SRS-22) questionnaire, is intended to be more applicable to patients with adolescent idiopathic scoliosis (AIS) between 10 and 18 years of age. METHODS: Eighty-four subjects with a mean age of 14.9 years participated. We determined reliability, validity, distribution of scores, and clinical utility of SQLI in a hospital setting. Seventy patients were AIS patients (16 postsurgical, 30 braced, 24 unbraced) with a mean Cobb angle of 30.7 degrees, and 14 patients were sibling controls. RESULTS: Reliability: Intraclass correlation coefficient for test-retest reliability of the global index was very good (ICC 2,1 = 0.80); Spearman's rho correlations between items and domains was 0.39 to 0.89 and between domains and global index was 0.55 to 0.78; Cronbach's alpha scores were more than 0.80 (0.82-0.89). VALIDITY: construct validity was established by correlations between SQLI's global index and Quality of Life Profile for Spine Deformities (QLPSD) global index (Spearman's rho, 0.79) and between SQLI domains and QLPSD domains (0.46-0.81); discriminate validity was established by SQLI's global index successfully partitioned controls and AIS subjects (Kruskal-Wallis test, P = 0.0013). Time required by the patient averaged 2.5 minutes per administration. CONCLUSIONS: SQLI is reliable and valid and demonstrates satisfactory distribution of scores. SQLI is a promising instrument in the assessment of AIS patients.

Adolescent↗

Status of activator methods chiropractic technique, theory, and practice.

OBJECTIVE: To provide an historical overview, description, synthesis, and critique of the Activator Adjusting Instrument (AAI) and Activator Methods Chiropractic Technique of clinical assessment. METHODS: Online resources were searched including Index to Chiropractic Literature, EBSCO Online, MANTIS, CHIROLARS, CINAHL, eJournals, Ovid, MDConsult, Lane Catalog, SU Catalog, and Pubmed. Relevant peer-reviewed studies, commentaries, and reviews were selected. Studies fell into 2 major content areas: instrument adjusting and the analysis system for therapy application. Studies were categorized by research content type: biomechanical, neurophysiological, and clinical. Each study was reviewed in terms of contribution to knowledge and critiqued with regard to quality. DISCUSSION: More than 100 studies related to the AAI and the technique were found, including studies on the instrument's mechanical effects, and a few studies on clinical efficacy. With regard to the analysis, there is evidence for good reliability on prone leg-length assessment, but to date, there is only 1 study evaluating the Activator Methods Chiropractic Technique analysis. CONCLUSION: A body of basic science and clinical research has been generated on the AAI since its first peer-reviewed publication in 1986. The Activator analysis may be a clinically useful tool, but its ultimate scientific validation requires testing using sophisticated research models in the areas of neurophysiology, biomechanics, and statistical analysis.

Clinical Trials as Topic↗

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.

Adult↗

Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions.

STUDY DESIGN: A prospective cohort design was used to evaluate the Functional Rating Index in a multicentered setting with 139 participants. The Functional Rating Index is a self-reporting instrument consisting of 10 items, each with 5 possible responses that express graduating degrees of disability. OBJECTIVES: The goal of this study was to evaluate the psychometric qualities of the Functional Rating Index. SUMMARY OF BACKGROUND DATA: The Functional Rating Index combines the concepts of the Oswestry Low Back Disability Questionnaire and the Neck Disability Index and seeks to improve on clinical utility (time required for administration). METHODS: One hundred thirty-nine subjects with spinal complaints participated in four different cohorts to study reliability, validity, responsiveness, and clinical utility. RESULTS: Reliability: Test-retest: Intraclass correlation coefficient was excellent (ICC3,k = 0.99); interitem correlation: Item efficiency was good, ranging between 0.54 and 0.82, with a moderate correlation among all items; Cronbach's alpha was excellent (0.92). VALIDITY: construct: The Functional Rating Index correlated with the Disability Rating Index (0.76), the Short Form-12 Physical Component Score (0.76), and the Short Form-12 Mental Component Score (0.36). Responsiveness: Overall, the size effect was 1.24, which is commendable. Clinical utility: Time required by the patient and staff averaged 78 seconds per administration, which is noteworthy. Effect of Sociodemographics: Total scores were not affected by education, gender, nor age, suggesting minimal external validity bias. CONCLUSIONS: The Functional Rating Index appears to be psychometrically sound with regard to reliability, validity, and responsiveness and is clearly superior to other instruments with regard to clinical utility. The Functional Rating Index is a promising useful instrument in the assessment of spinal conditions.

Adolescent↗