A Randomized, Single-Blind, Placebo-Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain.
ABSTRACT: Cized, single-blind, controlled trial.To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain.The AKA-H method is used to manually treat abnormalities of intra-articular movement.One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]).At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group.The AKA-H method can be effective in managing chronic low back pain.UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250.
Project description:OBJECTIVES:The Short Form 36 (SF-36) questionnaire is increasingly being used to measure health-related quality of life (HRQoL) in Indonesia. However, evidence that it is valid for use in Indonesian adults is lacking. This study assessed the validity and reliability of the SF-36 in Indonesian middle-aged and older adults. METHODS:Adults aged 46-81 years (n=206) in Yogyakarta, Indonesia completed the SF-36, another measure of HRQoL (the EuroQoL visual analogue scale [EQ-VAS]), and measures assessing their demographic characteristics. Fifty-four percent (n=121) completed the SF-36 measure again 1 week later. Confirmatory factor analysis was conducted to confirm the factor structure of the SF-36. Internal consistency reliability was estimated using Cronbach's alpha, and test-retest reliability was assessed using intraclass correlations. Convergent and discriminant validity were assessed by computing correlations among SF-36 subscales, between subscales and the 2 component scores, and between component scores and EQ-VAS scores. RESULTS:Most scaling assumptions were met. The hypothetical factor structure fit the data poorly (root mean square error of approximation [RMSEA]=0.108) and modification was required for a good fit (RMSEA=0.060). Scores on all subscales demonstrated acceptable internal consistency (?>0.70) and test-retest reliability (r>0.70). Divergent validity was supported by weak to moderate interscale correlations (r=0.19 to 0.64). As expected, the 2 summary scores were moderately to strongly correlated with the EQ-VAS (r>0.60). CONCLUSIONS:The findings adequately support the use of SF-36 in Indonesian middle-aged and older adults, although the optimal algorithm for computing component scores in Indonesia warrants further investigation.
Project description:It has been hypothesized that dexamethasone can inhibit persistent postoperative pain, but data on humans is lacking and results from animal studies are conflicting. We explored the effect of 16 mg dexamethasone IV administered preoperatively on persistent pain 1 year after lumbar discectomy.This is a prospective 1-year follow-up on a single-centre, randomized, and blinded trial exploring the analgesic effect of 16 mg IV dexamethasone or placebo after lumbar discectomy. One year follow-up was a written questionnaire including back and leg pain (VAS 0-100 mm), Short Form 36 survey (SF-36), EuroQol 5D (EQ-5D), OSWESTRY Low Back Pain Questionnaire, duration of sick leave, working capability, contentment with surgical result.Response rate was 71% (55 patients) in the dexamethasone group, 58% (44 patients) in the placebo group. Leg pain (VAS) was significantly lower in the placebo group compared to the dexamethasone group: 17 (95% CI 10-26) vs 26 (95% CI 19-33) mm, respectively (mean difference 9 mm (95% CI -1 to 0), (P?=?0.03). No difference regarding back pain. The placebo group reported significantly more improvement of leg pain and were significantly more satisfied with the surgical result. Patients in the dexamethasone group reported significantly higher pain levels in EQ-5D- and Oswestry questionnaires. No difference in the SF-36 survey or daily analgesic consumption.We found significantly higher pain levels in the dexamethasone group compared to placebo 1 year after lumbar disc surgery.Clinicaltrials.gov ( NCT01953978 ). Registered 26 Sep 2013.
Project description:OBJECTIVE:The aim of this randomized controlled study was to evaluate the efficacy of oral native type II collagen treatment on the symptoms and biological markers of cartilage degradation, when given concomitantly with acetaminophen in patients with knee osteoarthritis. MATERIALS AND METHODS:Thirty-nine patients diagnosed with knee osteoarthritis were included and randomly distributed into two groups: one treated with 1500 mg/day of acetaminophen (group AC; n=19) and the other treated with 1500 mg/day of acetaminophen plus 10 mg/day of native type II collagen (group AC+CII; n=20) for 3 months. Visual Analogue Scale (VAS) at rest and during walking, Western Ontario McMaster (WOMAC) pain, WOMAC function, and Short Form-36 (SF-36) scores, were recorded. Coll2-1, Coll2-1NO2 and Fibulin-3 levels were quantified in urine as biomarkers of disease progression. ClinicalTrials.gov: NCT02237989. RESULTS:After 3 months of treatment, significant improvements compared to baseline were reported in joint pain (VAS walking), function (WOMAC) and quality of life (SF-36) in the AC+CII group, while only improvements in some subscales of the SF-36 survey and VAS walking were detected in the AC group. Comparisons between the groups revealed a significant difference in VAS walking score in favour of the AC+CII group as compared to AC group. Biochemical markers of cartilage degradation in urine did not significantly improve in any of the groups. CONCLUSION:All in all, these results suggest that native type II collagen treatment combined with acetaminophen is superior to only acetaminophen for symptomatic treatment of patients with knee osteoarthritis.
Project description:BACKGROUND: Gastroesophageal reflux disease (GERD) causes a wide range of clinical symptoms and potentially serious complications, but epidemiological data about GERD in China are limited. The aim of this pilot study was to develop and validate a methodology for the epidemiological study of GERD in China. METHODS: Regionally stratified, randomized samples of Shanghai residents (n = 919) completed Mandarin translations of the Reflux Disease Questionnaire (RDQ), GERD Impact Scale, Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and 36-item Short Form Health Survey (SF-36). Reliability and construct validity were tested by appropriate statistical analyses. RESULTS: The response rate was 86%. The test-retest reliability coefficients for the RDQ, GERD Impact Scale, QOLRAD and SF-36 were 0.80, 0.71, 0.93 and 0.96, respectively, and Cronbach's alpha coefficients were 0.86, 0.80, 0.98 and 0.90, respectively. Dimension scores were highly correlated with the total scores for the QOLRAD and SF-36, and factor analysis showed credible construct validity for the RDQ, GERD Impact Scale and SF-36. The RDQ GERD score was significantly negatively correlated with QOLRAD dimensions of food and drink problems and social functioning, and was significantly negatively correlated with all dimensions of the SF-36. All eight of the SF-36 dimensions were significantly correlated with the QOLRAD total score. CONCLUSION: This study developed and tested a successful survey methodology for the investigation of GERD in China. The questionnaires used demonstrated credible reliability and construct validity, supporting their use in larger epidemiological surveys of GERD in China.
Project description:<h4>Background</h4>With increase of spine surgeries, failed back surgery syndrome (FBSS) prevalence is also rising. While complementary and alternative medicine (CAM) is commonly used for low back pain (LBP), there are no studies reporting use of integrative Korean medicine in FBSS patients.<h4>Methods</h4>Patients with pain continuing after back surgery or recurring within 1 year and visual analogue scale (VAS) of LBP or leg pain of ?6 (total n = 120) were recruited at 2 hospital sites from November 2011 to September 2014. Weekly sessions of integrative Korean medicine treatment were conducted for 16 weeks (herbal medicine, acupuncture/electroacupuncture, pharmacopuncture/bee venom pharmacopuncture, and Chuna manual therapy) with additional follow-ups at 24 weeks and 1 year. Outcome measures included VAS of LBP and leg pain (primary outcome), Oswestry Disability Index (ODI), Short-Form 36 (SF-36), medical use, and patient global impression of change (PGIC).<h4>Results</h4>VAS of LBP and leg pain improved at 6 months (LBP from 6.1±2.0 at baseline to 2.9±2.3; and leg pain from 5.4±2.6 to 2.4±2.5, respectively). Eighty patients (66.7%) showed improvement of 50% or more in main pain of LBP or leg pain from baseline. Disability and quality of life also improved at 6 months (ODI from 41.3±12.3 at baseline to 23.6±13.6; and SF-36 from 42.8±14.5 to 62.7±16.8). At 1 year follow-up, conventional medical management use decreased, improvement in pain and disability was maintained, and 79.2% reported improvement of PGIC.<h4>Conclusions</h4>Despite limitations as an observational study, integrative Korean medicine treatment showed positive results in pain, function, and quality of life of FBSS patients.
Project description:To assess validity of pain and patient global scales in gout.The authors used data from pegloticase clinical trials in chronic refractory gout to examine the validity of visual analogue scale (VAS) pain, Short-Form 36 (SF-36) bodily pain subscale and VAS patient global assessment (all scales 0-100). Convergent/divergent validity with clinical characteristics was tested by using Spearman's correlation coefficient. For discriminant ability, the authors compared the change at 6 months between placebo and pegloticase arms and calculated effect size (ES) and standardised response mean (SRM).212 patients (mean age, 55.4 years, 82% men; 73% with tophaceous gout) provided data. VAS pain was statistically significantly correlated with tender joints (r=0.42), swollen joints (r=0.30), SF-36 physical (r=-0.56) and Mental Component Summary (r=-0.36) and Health Assessment Questionnaire scores (r=0.54; all p-values <0.0001), but not disease duration (r=-0.01; p=0.84), gout flares (r=0.12; p=0.08), comorbidities (r=0.05; p=0.47) or plasma urate (r=0.01; p=0.89). Similar and significant correlation coefficients with tender and swollen joints were noted for VAS patient global assessment (r=0.35 and 0.23; p<0.0012 for both) and SF-36 pain subscale (r=-0.27 and -0.19; p<0.006 for both). Pegloticase group had significantly more improvement than placebo at 6 months, mean (SD): VAS pain, -9.2 (29.3) versus 1.9 (26.4), p=0.0002; SF-36 pain, 14.6 (25.6) versus -0.04 (21.1), p<0.0001; and patient global, -9.3 (26.5) versus 3.4 (22.8), p<0.0001. ES and SRMs in pegloticase group were as follows: VAS pain, 0.34 and 0.30; SF-36 pain, 0.69 and 0.57; patient global, 0.49 and 0.44.VAS pain, SF-36 pain and patient global VAS are valid outcome measures in patients with chronic gout.
Project description:INTRODUCTION:Chronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT. METHODS:The purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics. RESULTS:Older veterans (? 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups. CONCLUSIONS:The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
Project description:BACKGROUND:The Hip disability and Osteoarthritis Outcome Score (HOOS) is a frequently used patient-reported outcome measure (PROM) for assessment of hip disorders and treatment effects following hip surgery. The objective of the study was to translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into Polish and to investigate the psychometric properties of the HOOS in patients with osteoarthritis undergoing total hip replacement (THR). MATERIALS AND METHODS:The Polish version of the HOOS was developed according to current guidelines. Patients completed the HOOS, Short Form 36 Health Survey (SF-36), the visual analogue scale (VAS) for pain and the global perceived effect (GPE) scale. Psychometric properties including interpretability (floor/ceiling effects), internal consistency (Cronbach's alpha), test-retest reliability (intra-class correlation coefficient, ICC), convergent construct validity (a priori hypothesized Spearman's correlations between the HOOS subscales, the generic SF-36 measure and the VAS for pain) and responsiveness (effect size, association between the HOOS and GPE scores) were analyzed. RESULTS:The study included 157 patients (mean age 66.8?years, 54% women). Floor effects were found prior to THR for the HOOS subscales Sports and Recreation and Quality of Life. The Cronbach's alpha was over 0.7 for all subscales indicating satisfactory internal consistency. The test-retest reliability was good for the HOOS subscale Pain (0.82) and excellent for all other subscales with ICCs ranging from 0.91 to 0.96. The minimal detectable change ranged from 12.0 to 26.2 on an individual level and from 1.4 to 3.0 on a group level. Seven out of eight a priori hypotheses were confirmed indicating good construct validity. Responsiveness was high since the expected pattern of effect sizes in all subscales was found. CONCLUSIONS:The Polish version of the HOOS demonstrated good reliability, validity and responsiveness for use in patient groups having THR.
Project description:We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial.110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n =?37), minimal cupping with 8 treatments plus paracetamol on demand (n =?36) or the control group with paracetamol on demand only (n?=?37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks.The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p <?0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p =?0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p =?0.014), and between minimal cupping vs. control 11.5 ((-?0.44; 23.4); p =?0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (-?5.8 (-?11.5;-0.1); p =?0.045) compared to control for back function after 4 weeks, but not after 12 weeks (-?5.4 (-?11.7;0.8); p =?0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (-?5.6 (-?9.3;-2.0); p =?0.003; -?6.1 (-?9.9;-2.4); p =?0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (-?0.4;15.0); p =?0.063); minimal cupping vs. control (6.3 (-?2.0;14.5); p =?0.133).Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks.The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).
Project description:Ossification of the posterior longitudinal ligament (OPLL) can occur throughout the entire spine and can sometimes lead to spinal disorder. Although patients with OPLL sometimes develop physical limitations because of pain, the characteristics of pain and effects on activities of daily living (ADL) have not been precisely evaluated in OPLL patients. Therefore, we conducted a multi-center prospective study to assess whether the symptoms of cervical OPLL are different from those of cervical spondylosis (CS). A total of 263 patients with a diagnosis of cervical OPLL and 50 patients with a diagnosis of CS were enrolled and provided self-reported outcomes, including responses to the Japanese Orthopaedic Association (JOA) Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), JOA Back Pain Evaluation Questionnaire (JOABPEQ), visual analog scale (VAS), and SF-36 scores. The severity of myelopathy was significantly correlated with each domain of the JOACMEQ and JOABPEQ. There was a negative correlation between the VAS score for each domain and the JOA score. There were significantly positive correlations between the JOA score and the Mental Health, Bodily Pain, Physical Functioning, Role Emotional, and Role Physical domains of the SF-36. One-to-one matching resulted in 50 pairs of patients with OPLL and CS. Although there was no significant between-group difference in scores in any of the domains of the JOACMEQ or JOABPEQ, the VAS scores for pain or numbness in the buttocks or limbs were significantly higher in the CS group; however, there was no marked difference in low back pain, chest tightness, or numbness below the chest between the two study groups. The scores for the Role Physical and Body Pain domains of the SF-36 were significantly higher in the OPLL group than in the CS group, and the mean scores for the other domains was similar between the two groups. The results of this study revealed that patients with OPLL were likely to have neck and low back pain and restriction in ADL. No specific type of pain was found in patients with OPLL when compared with those who had CS.