-
Genetic contribution of catechol-Omethyltransferase variants in treatment outcome of low back pain: a prospective genetic association study
Background:
Treatment outcome of low back pain (LBP) is associated with inter-individual variations in pain relief and functional disability. Genetic variants of catechol-O-methyltransferase (COMT) gene have previously been shown to be associated with pain sensitivity and pain medication. This study examines the association between COMT polymorphisms and 7-11 year change in Oswestry Disability Index (ODI) and Visual Analog Score (VAS) for LBP as clinical outcome variables in patients treated with surgical instrumented lumbar fusion or cognitive intervention and exercise.
Methods:
93 unrelated patients with chronic LBP for duration of >1 year and lumbar disc degeneration (LDD) were treated with lumbar fusion (N = 60) or cognitive therapy and exercises (N = 33). Standardised questionnaires assessing the ODI, VAS LBP, psychological factors and use of analgesics, were answered by patients both at baseline and at 7-11 years follow-up. Four SNPs in the COMT gene were successfully genotyped. Single marker as well as haplotype association with change in ODI and VAS LBP, were analyzed using Haploview, linear regression and R-package Haplostats. P-values were not formally corrected for multiple testing as this was an explorative study.
Results:
Association analysis of individual SNPs adjusted for covariates revealed association of rs4633 and rs4680 with post treatment improvement in VAS LBP (p = 0.02, mean difference (beta) = 13.5 and p = 0.02, beta = 14.2 respectively). SNPs, rs4633 and rs4680 were found to be genotypically similar and in strong linkage disequilibrium (LD). A significant association was found with covariates, analgesics (p = 0.001, beta = 18.6); anxiety and depression (p = 0.008, beta = 15.4) and age (p = 0.03, mean difference per year (beta) = 0.7) at follow-up. There was a tendency for better improvement among heterozygous patients compared to the homozygous. No association was observed for the analysis of the common haplotypes, these SNPs were situated on.
Conclusions:
Results suggest an influence of genetic variants of COMT gene in describing the variation in pain after treatment for low back pain. Replication in large samples with testing for other pain related genes is warranted.
-
Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial.
Background:
A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the tailored treatment has better short, intermediate and long-term effects than either non-tailored treatment or treatment-as-usual (TAU) on pain and function. We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU.
Methods:
120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20-65, are allocated by minimisation with the factors age, duration of pain, pain intensity and disability in to the groups tailored treatment (T), non-tailored treatment (NT) or treatment-as-usual (TAU). Treatment is given to the groups T and NT for 11 weeks (27 sessions evenly distributed). An extensive presentation of the tests and treatment decision model is provided. The main treatment components are manual therapy, cranio-cervical flexion exercise and strength training, EMG-biofeedback training, treatment for cervicogenic headache, neck motor control training. A decision algorithm based on the baseline assessment determines the treatment components given to the each participant of T- and NT-groups. Primary outcome measures are physical functioning (Neck Disability Index) and average pain intensity last week (Numeric Rating Scale). Secondary outcomes are general improvement (Patient Global Impression of Change scale), symptoms (Profile Fitness Mapping neck questionnaire), capacity to work in the last 6 weeks (quality and quantity) and pressure pain threshold of m. trapezius. Primary and secondary outcomes will be reported for each group with effect size and its precision.DiscussionWe have chosen not to include women with psychological ill-health and focus on biomedical aspects of neck pain. Future studies should aim at including psychosocial aspects in a widened treatment decision model. No important adverse events or side-effects are expected.Trial registration: Current Controlled Trials registration ISRCTN49348025.Key words: Neck, trapezius, myalgia, neck-shoulder pain, RCT, individualized treatment, rehabilitation, physiotherapy, tailored.
-
German fibromyalgia consumer reports - a crosssectional survey
Background:
Consumer surveys provide information on effectiveness and side effects of medical interventions in routine clinical care. A report of fibromyalgia syndrome (FMS) consumers has not been carried out in Europe.
Methods:
The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacologicalFMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). The questionnaire was distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to allconsecutive FMS patients of nine clinical centers of different levels of care.
Results:
1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. The most frequently used therapies were self-management strategies, prescription pain medication and aerobic exercise. The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, localcold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems
Conclusion:
The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS, and challenges the strong recommendationsfor drug therapies given by FMS-guidelines.
-
Effect of leisure time physical activity on severe knee or hip osteoarthritis leading to total joint replacement: a population-based prospective cohort study
Background:
Studies on leisure time physical activity as risk factor or protective factor for knee or hip osteoarthritis (OA) show divergent results. Longitudinal prospective studies are needed to clarify the association of physical activity with future OA. The aim was to explore in a prospective population-based cohort study the influence of leisure time physical activity on severe knee or hip OA, defined as knee or hip replacement due to OA.
Methods:
Leisure time physical activity was reported by 28320 participants (mean age 58 years (SD 7.6), 60% women) at baseline. An overall leisure time physical activity score, taking both duration and intensity of physical activities into account, was created. The most commonly reported activities were also used for analysis. The incidence of knee or hip replacement due to OA over 11 years was monitored by linkage with the Swedish hospital discharge register. Cox's proportional hazards model (crude and adjusted for potential confounding factors) was used to assess the incidence of total joint replacement, or osteotomy (knee), in separate analyses of leisure time physical activity.
Results:
There was no significant overall association between leisure time physical activity and risk for knee or hip replacement due to OA over the 11-year observation time. For women only, the adjusted RR (95% CI) for hip replacement was 0.66 (0.48, 0.89) (fourth vs. first quartile), indicating a lower risk of hip replacement in those with the highest compared with the lowest physical activity. The most commonly reported activities were walking, bicycling, using stairs, and gardening. Walking was associated with a lower risk of hip replacement (adjusted RR 0.76 (95% CI 0.61, 0.94), specifically for women (adjusted RR 0.75 (95% CI 0.57, 0.98)).
Conclusions:
In this population-based study of middle-aged men and women, leisure time physical activity showed no consistent overall relationship with incidence of severe knee or hip OA, defined as joint replacement due to OA, over 11 years. For women, higher leisure time physical activity may have a protective role for the incidence of hip replacement. Walking may have a protective role for hip replacement, specifically for women.
-
Biomechanical comparison of unilateral and bilateral pedicle screws fixation for transforaminal lumbar interbody fusion after decompressive
surgery -- a finite element analysis
Background:
Little is known about the biomechanical effectiveness of transforaminal lumbar interbody fusion (TLIF) cages in different positioning and various posterior implants used afterdecompressive surgery. The use of the various implants will induce the kinematic and mechanical changes in range of motion (ROM) and stresses at the surgical and adjacent segments. Unilateral pedicle screw with or without supplementary facet screw fixation in the minimally invasive TLIF procedure has not been ascertained to provide adequate stability without the need to expose on the contralateral side. This study used finite element (FE) models to investigate biomechanical differences in ROM and stress on the neighboring structures after TLIF cages insertion in conjunction with posterior fixation.
Methods:
A validated finite-element (FE) model of L1-S1 was established to implant three types of cages (TLIF with a single moon-shaped cage in the anterior or middle portion of vertebral bodies, and TLIF with a left diagonally placed ogival-shaped cage) from the left L4-5 levelafter unilateral decompressive surgery. Further, the effects of unilateral versus bilateral pedicle screw fixation (UPSF vs. BPSF) in each TLIF cage model was compared to analyze parameters, including stresses and ROM on the neighboring annulus, cage-vertebral interface and pedicle screws.
Results:
All the TLIF cages positioned with BPSF showed similar ROM (<5 %) at surgical and adjacent levels, except TLIF with an anterior cage in flexion (61 % lower) and TLIF with a left diagonal cage in left lateral bending (33 % lower) at surgical level. On the other hand, the TLIF cage models with left UPSF showed varying changes of ROM and annulus stress in extension, right lateral bending and right axial rotation at surgical level. In particular, the TLIF model with a diagonal cage, UPSF, and contralateral facet screw fixation stabilize segmental motion of the surgical level mostly in extension and contralaterally axial rotation. Prominent stress shielded to the contralateral annulus, cage-vertebral interface, and pediclescrew at surgical level. A supplementary facet screw fixation shared stresses around the neighboring tissues and revealed similar ROM and stress patterns to those models with BPSF.
Conclusions:
TLIF surgery is not favored for asymmetrical positioning of a diagonal cage and UPSF used in contralateral axial rotation or lateral bending. Supplementation of a contralateral facetscrew is recommended for the TLIF construct.
-
Effects of neuromuscular electrical stimulation, laser therapy and LED therapy on the masticatory system and the impact on sleep variables in cerebral palsy patients: a randomized, five arms clinical trial.
Background:
Few studies demonstrate effectiveness of therapies for oral rehabilitation of patients with cerebral palsy (CP), given the difficulties in chewing, swallowing and speech, besides the intellectual, sensory and social limitations. Due to upper airway obstruction, they are also vulnerable to sleep disorders. This study aims to assess the sleep variables, through polysomnography, and masticatory dynamics, using electromiography, before and after neuromuscular electrical stimulation, associated or not with low power laser (Gallium Arsenide- Aluminun, = 780nm) and LED ( = 660 nm) irradiation in CP patients. Methods/Design: 50 patients with CP, both gender, aged between 19 and 60 years will be enrolled in this study. The inclusion criteria are: voluntary participation, patient with hemiparesis, quadriparesis or diparetic CP, with ability to understand and respond to verbal commands. The exclusion criteria are: patients undergoing / underwent orthodontic, functional maxillary orthopedic or botulinum toxin treatment. Polysomnographic and surface electromyographic exams on masseter, temporalis and suprahyoid will be carry out in all sample. Questionnaire assessing oral characteristics will be applied. The sample will be divided into 5 treatment groups: Group 1: neuromuscular electrical stimulation; Group 2: laser therapy; Group 3: LED therapy; Group 4: neuromuscular electrical stimulation and laser therapy and Group 5: neuromuscular electrical stimulation and LED therapy. All patients will be treated during 8 consecutive weeks. After treatment, polysomnographic and electromiographic exams will be collected again. Discussion: This paper describes a five arm clinical trial assessing the examination of sleep quality and masticatory function in patients with CP under non-invasive therapies.
-
The effect of physical loading on calcaneus quantitative ultrasound measurement: a cross-section study
Background:
Physical loading leads to a deformation of bone microstructure and may influence quantitative ultrasound (QUS) parameters. This study aims at evaluating the effect of physical loading on bone QUS measurement, and further, on the potential of diagnosing osteoporosis using QUS method under physical loading condition.
Methods:
16 healthy young females (control group) and 45 postmenopausal women (divided into 3 groups according to the years since menopause (YSM)) were studied. QUS parameters were measured at calcaneus under self-weight loading (standing) and no loading (sitting) conditions. Weight-normalized QUS parameter (QUS parameter measured under loading condition divided by the weight of the subject) was proposed to evaluate the influence of loading. T-test, One-Way analysis of variance (one way ANOVA) and receiver operating characteristic (ROC) analysis were applied for analysis.
Results:
In QUS parameters, mainly normalized broadband ultrasound attenuation (nBUA), measured with loading significantly differed from those measured without loading (p<0.05). The relative changes of weight-normalized QUS parameters on postmenopausal women with respect to premenopausal women under loading condition were larger than those on traditional QUS parameters measured without loading. In ROC analysis, weight-normalized QUS parameters showed their stronger discriminatory ability for menopause.
Conclusions:
Physical loading substantially influenced bone QUS measurement (mainly nBUA). Weight-normalized QUS parameters can discriminate menopause more effectively. By considering the high relationship between menopause and osteoporosis, an inference was drawn that adding physical loading during measurement may be a probable way to improve the QUS based osteoporosis diagnosis.
-
Engaging consumers living in remote areas of Western Australia in the self-management of back pain: a prospective cohort study
Background:
In Western Australia (WA), health policy recommends encouraging the use of active self-management strategies as part of the co-care of consumers with persistent low back pain (LBP). As many areas in WA are geographically isolated and health services are limited, implementing this policy into practice is critical if health outcomes for consumers living in geographically-isolated areas are to be improved.
Methods:
In this prospective cohort study, 51 consumers (mean (SD) age 62.3 (+/-15.1) years) participated in an evidence-based interdisciplinary pain education program (modified Self Training Educative Pain Sessions: mSTEPS) delivered at three geographically isolated WA sites. Self report measures included LBP beliefs and attitudes (Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)), use of active and passive self-management strategies, and health literacy, and global perceived impression of usefulness (GPIU) recorded immediately pre-intervention (n=51), same day post-intervention (BBQ; GPIU, n=49) and 3 months post-intervention (n=25).
Results:
At baseline, consumers demonstrated adequate health literacy and elements of positive health behaviours, reflected by the use of more active than passive strategies in self-managing their persistent LBP. Immediately post-intervention, there was strong evidence for improvement in consumers' general beliefs about LBP as demonstrated by an increase in BBQ scores (baseline [mean (SD): 25.8 (7.6)] to same day post-intervention [28.8 (7.2); P<0.005], however this improvement was not sustained at 3 months post-intervention. The majority of consumers (86.4%) reported the intervention as very useful [rated on NRS as 7-10].
Conclusions:
To sustain improved consumer beliefs regarding LBP and encourage the adoption of more positive health behaviours, additional reinforcement strategies for consumers living in remote areas where service access and skilled workforce are limited are recommended. This study highlights the need for aligning health services and skilled workforce to improve the delivery of co-care for consumers living in geographically isolated areas.
-
Principles of brain plasticity in improving sensorimotor function of the knee and leg in patients with anterior cruciate ligament injury: A double-blind randomized exploratory trial
Background:
Severe traumatic knee injury, including injury to the anterior cruciate ligament (ACL), leads to impaired sensorimotor function. Although improvements are achieved by training, impairment often persists. Because good sensorimotor function is associated with better patient-reported function and a potential lower risk of future joint problems, more effective treatment is warranted. Temporary cutaneous anesthesia of adjacent body parts was successfully used on the hand and foot to improve sensorimotor function. The aim of this study was to test whether this principle of brain plasticity could be used on the knee. The hypothesis was that temporary anesthesia of the skin area above and below the knee would improve sensorimotor function of the ipsilateral knee and leg in subjects with ACL injury.
Methods:
In this double-blind exploratory study, 39 subjects with ACL injury (mean age 24 years, SD 5.2, 49% women, mean 52 weeks after injury or reconstruction) and self-reported functional limitations and lack of trust in the knee were randomized to temporary local cutaneous application of anesthetic (EMLA) (n=20) or placebo cream (n=19). Fifty grams of EMLA, or placebo, was applied on the leg 10 cm above and 10 cm below the center of patella, leaving the area around the knee without cream. Measures of sensory function (perception of touch, vibration sense, knee kinesthesia) and motor function (knee muscle strength, hop test) were assessed before and after 90 minutes of treatment with EMLA or placebo. The paired t-test was used for comparisons within groups and analysis of variance between groups, except for ordinal data where the Wilcoxon signed rank test, or Mann-Whitney test, was used. The number of subjects needed was determined by an a priori sample size calculation.
Results:
No statistically significant or clinically relevant differences were seen over time (before vs. after) in the measures of sensory or motor functions in the EMLA group or in the placebo group. There were no differences between the groups due to treatment effect (EMLA vs. placebo).
Conclusion:
Temporary cutaneous anesthesia of adjacent body parts had no effect in improving sensorimotor function of the knee and leg in subjects with severe traumatic knee ligament injury.
-
Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: A randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study)
Background:
There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.
Methods:
The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade [greater than or equal to]2) and mean pain during the previous week of [less than or equal to] 60 mm (0-100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.DiscussionThis is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.Trial Registration: clinicaltrials.gov reference: NCT01410409
|
