Overnight use of continuous low-level heatwrap therapy for relief of low back pain

OBJECTIVE: To evaluate of the efficacy and safety of 8 hours of continuous, low-level heatwrap therapy administered during sleep. DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Two community-based research facilities. PARTICIPANTS: Seventy-six patients, aged 18 to 55 years, with acute, nonspecific low back pain. INTERVENTIONS: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following treatments: evaluation of efficacy (heatwrap, n=33; oral placebo, n=34) or blinding (unheated wrap, n=5; oral ibuprofen, n=4). All treatments were administered for 3 consecutive nights with 2 days of follow-up. MAIN OUTCOME MEASURES: Primary: morning pain relief (hour 0) on days 2 through 4 (0-5-point verbal response scale). Secondary: mean daytime pain relief score (days 2-4, hours 0-8), mean extended pain relief score (day 4, hour 0; day 5, hour 0), muscle stiffness, lateral trunk flexibility, and disability (Roland-Morris Disability Questionnaire). RESULTS: Heatwrap therapy was significantly better than placebo at hour 0 on days 2 through 4 for mean pain relief (P=.00005); at hours 0 through 8 on days 2 through 4 for pain relief (P<.001); at hour 0 on day 4 and at hour 0 on day 5 for mean pain relief (P<.001); on day 4 in reduction of morning muscle stiffness (P<.001); for increased lateral trunk flexibility on day 4 (P<.002); and for decreased low back disability on day 4 (P=.005). Adverse events were mild and infrequent. CONCLUSIONS: Overnight use of heatwrap therapy provided effective pain relief throughout the next day, reduced muscle stiffness and disability, and improved trunk flexibility. Positive effects were sustained more than 48 hours after treatments were completed.     

Increasing days at work using function-centered rehabilitation in nonacute nonspecific low back pain: a randomized controlled trial

OBJECTIVE: To evaluate the effect of function-centered compared with pain-centered inpatient rehabilitation in patients whose absence from work is due to chronic nonspecific low back pain (LBP). DESIGN: Single-blinded randomized controlled trial with follow-up assessments immediately after treatment and at 3 months. SETTING: Center for work rehabilitation in Switzerland. PARTICIPANTS: Patients with more than 6 weeks of work absence due to chronic nonspecific LBP (N=174; 137 men, 37 women; mean age +/- standard deviation, 42+/-8 y; mean sick leave before study, 6.5 mo). INTERVENTIONS: Function-centered treatment (FCT) (4h/d, 6d/wk, for 3 wk) consisted of work simulation, strength, endurance, and cardiovascular training. Pain-centered treatment (PCT) (2.5h/d, 6d/wk, for 3 wk) used a mini back school, individually selected passive and active mobilization, stretching, and low-intensity strength training. MAIN OUTCOME MEASURES: The number of days at work in 3 months after treatment, self-efficacy, lifting capacity, pain, mobility, strength, and global perceived effect. Effect sizes (ESs) (Cohen d ) were defined as small (ES range, 0.2-0.5), moderate (ES range, 0.5-0.8), and large (ES, >0.8). RESULTS: Groups were comparable at baseline. Moderate ESs for the FCT group versus PCT group were found for days at work (25.9 d vs 15.8d, ES=.36, P =.029), self-efficacy (5.9 points vs -7.4 points, ES=.55, P =.003), and lifting capacity (2.3 kg vs 0.2 kg, ES=.54, P =.004). CONCLUSIONS: Function-centered rehabilitation increases the number of work days, self-efficacy, and lifting capacity in patients with nonacute nonspecific LBP.     

Continuous low-level heat wrap therapy is effective for treating wrist pain

OBJECTIVE: To evaluate the efficacy of continuous low-level heat wrap therapy for the treatment of various sources of wrist pain including strain and sprain (SS), tendinosis (T), osteoarthritis (OA), and carpal tunnel syndrome (CTS). DESIGN: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial. SETTING: Two community-based research facilities. PARTICIPANTS: Ninety-three patients (age range, 18-65 y) with wrist pain. INTERVENTION: Subjects with moderate or greater wrist pain were randomized and stratified to 1 of the following treatments: efficacy evaluation (heat wrap, n=39; oral placebo, n=42) or blinding (oral acetaminophen, n=6; unheated wrap, n=6). Data were recorded over 3 days of treatment and 2 days of follow-up. MAIN OUTCOME MEASURES: The primary comparison was between the heat wrap and the oral placebo group among SS/T/OA subjects for pain relief. Outcome measures included pain relief (0-5 scale), joint stiffness (101-point numeric rating scale), grip strength measured by dynamometry, and perceived pain and disability (Patient Rated Wrist Evaluation [PRWE]); subjects with CTS also completed the Symptom Severity Scale and Functional Status Scale. RESULTS: Heat wrap therapy showed significant benefits in day 1 to 3 mean pain relief (P=.045) and increased day 3 grip strength (P=.02) versus oral placebo for the SS/T/OA group. However, joint stiffness and PRWE results were comparable between the 2 treatments. For the CTS group, heat wraps provided greater day 1 to 3/hour 0 to 8 mean pain relief (P=.001), day 1 to 3 mean joint stiffness reduction (P=.004), increased day 3 grip strength (P=.003), reduced PRWE scores (P=.0015), reduced symptom severity (P=.001), and improved functional status (P=.04). In addition, the heat wrap showed significant extended benefits through follow-up (day 5) in the CTS group. CONCLUSIONS: Continuous low-level heat wrap therapy was efficacious for the treatment of common conditions causing wrist pain and impairment.     

Acupuncture for acute non-specific low back pain: a pilot randomised non-penetrating sham controlled trial

OBJECTIVE: A pilot study to assess the feasibility of a trial to investigate the efficacy of acupuncture compared to placebo needling for the treatment of acute low back pain (LBP). As part of this, the study was designed to establish the credibility of the placebo control, and to provide data to inform a power analysis to determine numbers for a future trial. STUDY DESIGN: A pilot patient and assessor blinded randomized controlled trial. SETTING: Primary care health centre facility, South and East Belfast Trust, Northern Ireland. PATIENTS: Patients from the physiotherapy waiting list (n=48) with LBP of less than 12 weeks duration. OUTCOME MEASURES: Roland and Morris Disability Questionnaire (RMDQ), Visual Analogue Scale (VAS), medication use and an exit questionnaire were completed at baseline, end of treatment, and at 3 months follow up. RESULTS: Ninety-four percent (45/48) of patients completed assigned treatment, 83% (40/48) completed 3 months follow-up. The sham needle used here proved to be credible: 91.7% in the placebo group believed they had received acupuncture, compared to 95.8% in the verum acupuncture group. Differences in baseline characteristics were accounted for using ANCOVA. There was no significant difference between groups on the RMDQ over time. For pain, the only statistically significant difference was at the 3 months follow up (worst VAS, point estimate, 18.7, 95% CI 1.5-36.0, p=0.034). The majority of patients were taking some form of analgesic medication for LBP at the start of treatment (n=44; 92%), and at the end of treatment the verum acupuncture group were taking significantly fewer tablets of pain control medication (mean (S.D.): 1.0+/-0.3) than the placebo group (mean (S.D.): 4.2+/-0.6, p<0.05). Based upon these data, power analysis (power=90%, alpha=0.05, minimal clinically important difference (MCID) for RMDQ=2.5 points) indicated that 120 participants (60 per group) would be needed to complete an adequately powered randomized controlled trial. CONCLUSIONS: This study has demonstrated the feasibility of a randomized controlled trial of penetrating needle acupuncture compared to a non-penetrating sham for the treatment of acute LBP in primary care; 120 participants would be required in a fully powered trial. The placebo needle used in this study proved to be a credible form of control.     

Fear-avoidance beliefs about back pain in patients with acute LBP

OBJECTIVE: We aimed to assess fear-avoidance beliefs in patients with acute low back pain (LBP) and to identify features of patients and general practitioners (GPs) associated with patients' fear-avoidance beliefs. METHODS: A cross-sectional study conducted in primary care practice in France. A total of 709 GPs completed a self-administered questionnaire assessing fear-avoidance beliefs [the Fear-Avoidance Beliefs Questionnaire (FABQ)] and 2,727 patients with acute LBP completed a self-administered questionnaire assessing pain, perceived handicap and disability (on the Quebec Back Pain Disability Scale) and fear-avoidance beliefs (on the FABQ). RESULTS: Patients' FABQ mean scores were 16.8+/-5.0 for physical activities (FABQ Physical) and 19.5+/-10.9 for occupational activities (FABQ Work). From multivariate analysis, the following factors were associated with patients' FABQ Phys and Work scores: having a GP with a high rating on the FABQ Phys (P=0.0001 and 0.02 for FABQ Phys and Work, respectively), no sport practice (vs. occasional: P=0.0003 and 0.03; vs. usual/competition: P=0.0001 and 0.004), disability score (Quebec) (P=0.0001 for both FABQ scores), and pain intensity (P=0.0012 and 0.0013). CONCLUSIONS: High levels of fear-avoidance beliefs occur early in LBP patients, and key messages on this topic should probably be delivered at a very early stage of the disease.     

Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial.

We evaluated etoricoxib, a novel COX-2-specific inhibitor, in 319 patients with chronic low back pain (LBP) in this double-blind, placebo-controlled trial. Patients were randomized to a 60 mg dose (n = 103) or 90 mg dose (n = 107) of etoricoxib, or placebo (n = 109), daily for 12 weeks. The primary endpoint was low back pain intensity scale (Visual Analog Scale of 0- to 100-mm) time-weighted average change from baseline over 4 weeks. Other endpoints included evaluation over 3 months of low back pain intensity scale, Roland-Morris Disability Questionnaire (RMDQ), low back pain bothersomeness scale, patient- and investigator-global assessments, Patient Health Survey (MOS SF-12), rescue acetaminophen use, and discontinuation due to lack of efficacy. Etoricoxib provided significant improvement from baseline versus placebo in pain intensity (4 weeks: 12.9 mm and 10.3 mm for 60-mg and 90-mg doses, P <.001 for each; 12 weeks: 10.5 mm and 7.5 mm for 60-mg and 90-mg doses, P =.001 and.018, respectively). Etoricoxib at either dose led to significant improvement in other endpoints, including RMDQ scores, bothersomeness scores and global assessments. Etoricoxib given once daily provided significant relief of symptoms, and disability associated with chronic LBP that was observed 1 week after initiating therapy, was maximal at 4 weeks, and was maintained over 3 months.     

Value of myocardial contrast echocardiography for predicting left ventricular remodeling and segmental functional recovery after anterior wall acute myocardial infarction.

OBJECTIVE: We sought to study the value of microvascular perfusion assessed by myocardial contrast echocardiography in predicting left ventricular remodeling after anterior wall acute myocardial infarction. METHODS: In 31 patients myocardial contrast echocardiography was performed up to 48 hours after acute myocardial infarction with determination of end-diastolic and end-systolic volumes, wall-motion score index, and myocardial perfusion score index (MPSI) at rest and under dobutamine stress at 6 months. Patients were classified into remodeling group (RG) (n = 19) and non-RG (n = 12), and, according to number of segments without opacification, reflow (< or =2 segments, n = 15) and no-reflow (>2 segments, n = 16) groups. RESULTS: Wall-motion score index (1.84 +/- 0.22 vs 1.64 +/- 0.3; P =.049), MPSI (1.53 +/- 0.25 vs 1.26 +/- 0.17; P =.006), and number of segments without contrast (3.11 +/- 2.23 vs 1.08 +/- 1.38; P =.018) were higher in RG than in non-RG. End-diastolic and end-systolic volumes, and wall-motion score index, increased significantly in RG at 6 months and decreased in non-RG. MPSI increased in RG (1.53 +/- 0.25-1.66 +/- 0.21; P =.011) and was the only independent predictor of left ventricular remodeling (odds ratio = 1.8; 95% confidence interval = 1.15-2.82; P =.010). No-reflow group presented 27.8 +/- 19.9% of segments with resting functional recovery or contractile reserve, and reflow group presented 69.9 +/- 31.2% (P <.001). CONCLUSION: MPSI obtained 48 hours after acute myocardial infarction is an independent predictor of left ventricular remodeling. Patients with two or fewer segments without opacification revealed a better prognosis of resting ventricular function and contractile reserve.     

Endogenous opioid effects on motoneuron pool excitability: potential analgesic effect of acute exercise

BACKGROUND: Metabolic and thermal stresses of exercise mediate the release of endogenous opioids depressing motoneuron activation (MNA). Although exercise is routinely presented as a coequal treatment for management of acute and chronic low back pain (LBP), it is not clear that exercise-induced endogenous opioid release can play a role in the analgesic and treatment outcomes for patients with LBP. Furthermore, if opioid involvement is present, it is not clear what level of exercise might be beneficial in the suppression of MNA and possibly LBP. OBJECTIVE: To determine whether exercise-induced endogenous opioid release can play a role in the analgesic and treatment outcomes for patients with LBP and to determine what level of exercise might be beneficial in the suppression of MNA and possibly LBP. METHODS: To test this hypothesis, male (n = 3) and female (n = 3) healthy volunteers were tested 6 times over a 4-week period. The 6 trials included high-intensity treadmill exercise at 75% O(2max) with placebo or naloxone, low-intensity exercise at 40% O(2max) (placebo or naloxone) and no exercise control (placebo or naloxone). The evoked spinal Hoffmann H-reflex (soleus muscle) was measured as the criterion for MNA before and after exercise and expressed with the maximal M-wave as the maximal H(max)/M(max) percent ratio. Naloxone (10 mg) or isovolumic saline solution was administered double-blind (1 mL bolus) after recovery from exercise and before H-reflex measurement. RESULTS: The results show a significant reduction in the H(max)/M(max) percent ratio for both exercise conditions (40.0 +/- 7.1 to 33.9 +/- 9.1% for 75% O(2max) and 37.4 +/- 4.8 to 33.0 +/- 5.3% for 40% O(2max); P <.01). Naloxone treatment did not attenuate the exercise-induced H(max)/M(max) percent ratio suppression. CONCLUSION: Endogenous opioids do not appear to modulate motoneuron responses to exercise under these experimental conditions.     

Assessment of left ventricular systolic and diastolic function by Doppler tissue imaging in patients with preinfarction angina.

BACKGROUND: The aim of this study was assessment of left ventricular (LV) systolic and diastolic function by pulsed wave Doppler tissue imaging (DTI) in patients with or without preinfarction angina in acute myocardial infarction. METHODS: We prospectively evaluated 31 consecutive patients (4 women, 27 men; age 58 +/- 10 years) with a first acute myocardial infarction. LV systolic and diastolic function was assessed by classic methods and DTI on the third day during acute myocardial infarction. Patients were divided into 2 groups according to the presence (group 1; n = 10) or absence (group 2; n = 21) of preinfarction angina. Mitral inflow velocities and early diastolic mitral annular velocity (Em), late diastolic mitral annular velocity (Am), peak systolic mitral annular velocity, Em/Am, the ratio of early diastolic mitral inflow velocity (E) to Em, and myocardial performance index were calculated by DTI. RESULTS: Group 1 had significantly higher Em and Em/Am than group 2 (11.3 +/- 3.34 cm/s vs 7.4 +/- 2.07 cm/s, P <.0001; 1.01 +/- 0.38 cm/s vs 0.6 +/- 0.2 cm/s, P =.001, respectively). The E/Em ratio and myocardial performance index were significantly lower in group 1 than in group 2 (5.1 +/- 2.92 vs 8.10 +/- 3.15, P=.018; 0.49 +/- 0.15 vs 0.65 +/- 0.24, P =.042, respectively). Wall-motion score index was lower in those with preinfarction angina than in those without (1.6 +/- 0.36 vs 1.9 +/- 0.39; P =.04, respectively). Peak systolic mitral annular velocity and Am were not statistically different between groups (9.4 +/- 1.84 vs 8.3 +/- 2.03, P =.172; 11.7 +/- 3.07 vs 12.1 +/- 3.34, P =.72, respectively). There were no significant differences between the 2 groups regarding transmitral E velocity, atrial contraction mitral inflow velocity (A), E/A ratio, isovolumetric relaxation time, and deceleration time of the mitral E wave (P =.91, P =.08, P =.58, P =.81, and P =.71, respectively). CONCLUSION: LV diastolic function was better in patients with preinfarction angina than in patients without. This condition could not be detected by conventional mitral inflow Doppler velocities, but could be detected by DTI. This preliminary evidence shows that DTI is better than conventional mitral Doppler indices in the assessment of a favorable LV diastolic function in patients with preinfarction angina.     

Topiramate in patients with episodic migraine: reducing the risk for chronic forms of headache

OBJECTIVE: The aim was to evaluate whether preventive treatment with topiramate in patients with episodic migraine reduces the risk of developing chronic forms of headache. BACKGROUND: Chronic forms of headache, including chronic migraine or medication overuse headache (MOH), are characterized by 15 or more headache days per month. Acute medication overuse has been shown to be a risk factor for developing chronic headache, but it is not known whether preventive treatment can reduce the risk of developing chronic forms of headache or the development of MOH. METHODS: Pooled data from 3 trials in patients with episodic migraine randomized either to treatment with 100 mg topiramate per day (n = 384) or with placebo (n = 372) were analyzed with regard to the number of headache days during a prospective 4-week baseline period and the individual final 4 weeks of each patient's treatment during the planned 26-week double-blind treatment period. RESULTS: The number of headache days per month in the topiramate versus the placebo-treated groups was 7.3 +/- 3.0 versus 7.3 +/- 3.1 during baseline and 4.1 +/- 4.2 versus 5.6 +/- 4.9 during the final 4 weeks, respectively (P < .001). At the end of the study, 8 versus 16 patients fulfilled International Headache Society criteria of chronic headache (odds ratio: 2.11, P= .082). Moreover, a significantly lower number of patients receiving topiramate treatment reported an increase in headache days per month by the end of the study when compared to placebo (66 vs 88 patients, respectively; odds ratio: 1.49, P < .05). Finally, the number of days with usage of acute medication was significantly lower in the topiramate arm compared with placebo (3.3 +/- 3.7 vs 4.3 +/- 3.6, respectively; P < .001). CONCLUSION: Preventive treatment with topiramate in patients with episodic migraine may reduce the risk of developing chronic forms of headache.     

Impact of continuous low level heatwrap therapy in acute low back pain patients: subjective and objective measurements

OBJECTIVES: Muscular pain is usually associated with increased muscle tension resulting in a vicious tension-pain-cycle, leading to increased alertness and stress. However, this has not been broadly evaluated using objective methods, for example, looking at neurophysiologic changes. The focus of this study was, therefore, to combine objective [spontaneous electroencephalogram (EEG) as a surrogate of alertness and stress] with subjective parameters (self-assessed pain affected variables) to investigate the effect of continuous low-level heat therapy in low back pain (LBP)-patients. METHODS: This investigation was a randomized, active controlled, parallel-designed study. Thirty patients were randomly assigned to one of 2 groups: the control group, in which patients were provided with oral analgesics (nonsteroidal anti-inflammatory drug) and instructed to use it if needed, and the treatment group, in which patients in addition to oral analgesics as rescue medication were provided with a heatwrap therapy. The objective parameters were assessed by measuring the power of frequency bands in the spontaneous EEG. The subjective parameters (sleep pattern, well-being, pain intensity, etc.) were assessed by a Pain, Sleep, and Stress Questionnaire. RESULTS: In the EEG-recordings, the heatwrap therapy group showed decreased power in Beta-1 and Beta-2 frequency bands compared with the control group, indicating a reduction in arousal. Also, in comparison to the control group, the heatwrap therapy group reported significantly reduced LBP, everyday situations being less stressful, a better night's sleep, and a decreased number of daytime naps. DISCUSSION: In addition to classic psychophysical assessment of pain-related parameters and sleep quality, performance in daily life, we were able to obtain objective measures (EEG) that suggest an acute therapeutic relaxation on the basis of the central nervous system effects accompanying the reported significant pain relief. We believe that this was due to a reduced nociceptive information load in LBP-patients after the use of the heatwrap therapy.     

Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy

BACKGROUND: Painful neuropathy is one of the most common long-term complications of diabetes mellitus and often proves difficult to relieve.METHODS: Patients with diabetic neuropathy with moderate or greater pain for at least 3 months, were evaluated for efficacy, safety and health-related quality of life (QOL) while receiving controlled-release (CR) oxycodone (OxyContin) or active placebo. Patients underwent washout from all opioids 2-7 days before randomization to 10 mg CR oxycodone or active placebo (0.25 mg benztropine) q12h. The dose was increased, approximately weekly, to a maximum of 40 mg q12h CR oxycodone or 1 mg q12h benztropine, with crossover to the alternate treatment after a maximum of 4 weeks. Acetaminophen, 325-650 mg q4-6h prn was provided as rescue.RESULTS: Thirty-six patients were evaluable for efficacy (21 men, 15 women, mean age 63.0+/-9.4 years). CR oxycodone resulted in significantly lower (P=0.0001) mean daily pain (21.8+/-20.7 vs. 48.6+/-26.6 mm VAS), steady pain (23.5+/-23.0 vs. 47.6+/-30.7 mm VAS), brief pain (21.8+/-23.5 vs. 46.7+/-30.8 mm VAS), skin pain (14.3+/-20.4 vs. 43.2+/-31.3 mm VAS), and total pain and disability (16.8+/-15.6 vs. 25.2+/-16.7; P=0.004). Scores from 6 of the 8 SF-36 domains and both summary scales, Standardized Physical Component (P=0.0002) and Standardized Mental Component (P=0.0338) were significantly better during CR oxycodone treatment. The number needed to treat to obtain one patient with at least 50% pain relief is 2.6 and clinical effectiveness scores favoured treatment with CR oxycodone over placebo (P=0.0001).CONCLUSION: CR oxycodone is effective and safe for the management of painful diabetic neuropathy and improves QOL.     

Safety and efficacy of a traditional herbal medicine (Throat Coat) in symptomatic temporary relief of pain in patients with acute pharyngitis: a multicenter,prospective, randomized,double-blinded,placebo-controlled study

OBJECTIVE: To investigate the safety and efficacy of Throat Coat) (Traditional Medicinals,) Sebastopol, CA), a traditional demulcent herbal tea, in comparison with a placebo tea in the symptomatic treatment of acute pharyngitis. DESIGN: Multicenter, prospective, randomized, double-blinded, placebo-controlled, two-armed, parallel-group clinical trial. SETTINGS: Three primary care clinics in Duluth, MN, Madison, WI, and Middleton, WI. SUBJECTS: Patients of both genders (>or=18 years of age) with clinical diagnoses of acute pharyngitis. INTERVENTIONS: Patients (n = 60) were randomly assigned to receive 5-8 oz of Throat Coat (n = 30) or a placebo (n = 30), four to six times daily. The study period was 2 to 7 days with a window for the follow-up visit of 2-10 days accounting for the variable duration of sore throat symptoms. OUTCOME MEASURES: Primary efficacy parameter: sum of pain intensity differences (SPID) for pain in throat on swallowing, calculated as the area under the curve (AUC) of pain intensity difference scores (assessed at 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes, and 30 minutes after treatment). Secondary efficacy parameter: total pain relief (TOTPAR), calculated as the AUC from time 0 (baseline) to 30 minutes of pain relief (assessed at 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes, and 30 minutes). RESULTS: Compared to placebo, intensity of throat pain when swallowing was significantly reduced by Throat Coat in intention to treat and valid for efficacy analysis (VEA). Significant differences in change from baseline pain were observed at 5 min (p = 0.007), 10 min (p = 0.005), 15 minutes (p = 0.01), 20 minutes (p = 0.05), and 30 minutes (p = 0.04) after completion of the first dose (VEA analysis). There was a statistically significant improvement of SPID in the Throat Coat-treated group: Least square means +/- standard error of the means (SEM) of SPID were -16.5 +/- 13.9 in the placebo group and -43.8 +/- 11.9 in the Throat Coat-treated group (p = 0.012). TOTPAR was also significantly higher in the Throat Coat-treated group: Least square means +/- SEM of TOTPAR were 32.4 +/- 12.8 in the placebo group and 53.6 +/- 10.9 in the Throat Coat-treated group (p = 0.031). This study shows that Throat Coat is significantly superior to placebo and provided a rapid, temporary relief of sore throat pain in patients with pharyngitis.     

Acupuncture treatment of chronic low-back pain -- a randomized, blinded, placebo-controlled trial with 9-month follow-up

There is some evidence for the efficacy of acupuncture in chronic low-back pain (LBP), but it remains unclear whether acupuncture is superior to placebo. In a randomized, blinded, placebo-controlled trial, we evaluated the effect of traditional acupuncture in chronic LBP. A total of 131 consecutive out-patients of the Department of Orthopaedics, University Goettingen, Germany, (age=48.1 years, 58.5% female, duration of pain: 9.6 years) with non-radiating LBP for at least 6 months and a normal neurological examination were randomized to one of three groups over 12 weeks. Each group received active physiotherapy over 12 weeks. The control group (n=46) received no further treatment, the acupuncture group (n=40) received 20 sessions of traditional acupuncture and the sham-acupuncture group (n=45) 20 sessions of minimal acupuncture.Changes from baseline to the end of treatment and to 9-month follow-up were assessed in pain intensity and in pain disability, and secondary in psychological distress and in spine flexion, compared by intervention groups.Acupuncture was superior to the control condition (physiotherapy) regarding pain intensity (P=0.000), pain disability (P=0.000), and psychological distress (P=0.020) at the end of treatment. Compared to sham-acupuncture, acupuncture reduced psychological distress (P=0.040) only. At 9-month follow-up, the superiority of acupuncture compared to the control condition became less and acupuncture was not different to sham-acupuncture.We found a significant improvement by traditional acupuncture in chronic LBP compared to routine care (physiotherapy) but not compared to sham-acupuncture. The trial demonstrated a placebo effect of traditional acupuncture in chronic LBP.     

Effects of a continuing education program on nurses' practices of cancer pain assessment and their acceptance of patients' pain reports

A hospital-based quasi-experimental (pretest and post-test) study was conducted in Kaohsiung Veteran General Hospital, Taiwan. This study was to evaluate a continuing education program (CEP) on nurses' practices of cancer pain assessment and their acceptance of patients' pain reports with respect to four types of misconceptions. A questionnaire was sent to on-duty nurses or head nurses with patient care responsibilities before the implementation of CEP (n=645) and six months after the program (n=630). The response rates were 92.6% and 91.3% for pretest and post-test surveys, respectively. The CEP was implemented in 8 weeks with four-repeated sessions of 4-hour lectures. A one-day workshop focused on cancer pain assessment and treatment was held 3 months after the four-repeated sessions. Several educational strategies and teaching materials were used in the CEP. The results showed that CEP made statistically significant yet moderate improvement in nurses' practices of pain assessment using pain rating scales (pretest 3.29+/-0.76 vs. post-test 3.48+/-0.75, P<0.001) and acceptance of patient's pain reports without misconceptions on addiction (3.12+/-0.80 vs. 3.39+/-0.90, P<0.001), phantom pain (3.91+/-0.96 vs. 4.07+/-0.92, P=0.005), and placebo testing (3.63+/-0.72 vs. 3.81+/-0.73, P<0.001), except on patient gender-age-related doubts (3.60+/-0.72 vs. 3.67+/-0.77, P=0.109). In order to achieve further improvement, additional follow-up CEP combined with a hospital-wide institutionalization of pain assessment should be promoted and implemented in the future.     

Risk factors for non-specific low back pain in schoolchildren and their parents: a population based study

A survey of adolescent schoolchildren and their parents through a self-administered questionnaire was conducted to determine the prevalence of low back pain (LBP) in schoolchildren and their parents and to assess its association with exposure to known and presumed risk factors. A previously validated, self-administered questionnaire was used for collecting information on back pain history, anthropometric measures, physical and sports activity, academic problems, hours of leisure sitting, smoking, and alcohol intake. Schoolchildren between the ages of 13 and 15 in schools of the island of Mallorca and their parents (n=16,394) took part in the study. The lifetime prevalence of LBP was 50.9% for boys and 69.3% for girls; point prevalence (7 days) was 17.1% for boys and 33% for girls. There was a significant association with LBP and pain in bed (OR=13.82, 95% CI: 10.47-18.25, P<0.001), reporting scoliosis (OR=2.87, 95% CI: 2.45-3.37, P<0.001), reporting difference in leg length (OR=1.26, 95% CI: 1.02-1.56, P=0.033), practice of any sport more than twice a week (OR=1.23, 95% CI: 1.09-1.39, P=0.001) and being female (OR=1.11, 95% CI: 1.04-1.19, P=0.001). There was no association found between LBP and body mass index, the manner in which books were transported, hours of leisure sitting, alcohol intake or cigarette smoking. Among parents, the lifetime prevalence of LBP was 78.2% for mothers and 62.6% for fathers; point prevalence (7 days) was 41% for mothers and 24.3% for fathers, and there were significant associations with LBP and pain in bed (OR=18.07, 95% CI: 14.72-22.19, P<0.001), report of scoliosis (OR=8.77, 95% CI: 6.44-11.95, P<0.001), report of difference in leg length (OR=2.21, 95% CI: 1.60-3.04, P<0.001), being a university graduate (OR=1.89, 95% CI: 1.21-2.98, P=0.006), being female (OR=1.49, 95% CI: 1.33-1.67, P<0.001), and swimming (OR=1.10, 95% CI: 1.4-1.18, P=0.002). There was no association found between LBP and alcohol intake, cigarette smoking or the practice of other sports. Although there was a positive association in terms of scoliosis between biological parents and their children (P<0.001), there was no association found in familial (biological or not) occurrence of LBP. The prevalence of LBP among adolescents in southern Europe is similar to northern Europe, it is comparable to that in adults, and is associated with several factors. There is a strong association between pain in bed or upon rising in both adolescents and adults. Scoliosis, but not LBP, appears to be related to heredity. Further longitudinal studies are necessary to establish risk factors that are predictive for LBP in adolescents.     

The effect of silicone injections in the diabetic foot on peak plantar pressure and plantar tissue thickness: a 2-year follow-up

OBJECTIVE: To report the efficacy of injected liquid silicone (ILS) in the foot at 2 years after administration. DESIGN: Randomized controlled trial. SETTING: Diabetic foot clinic in the United Kingdom. PARTICIPANTS: Twenty-eight diabetic neuropathic patients, randomized into an active treatment group (n=14) and a placebo group (n=14). INTERVENTION: Participants were given either 6 injections of 0.2mL of liquid silicone (silicone group) or equal volumes of saline (placebo group) under metatarsal head sites with callus. MAIN OUTCOME MEASURES: Plantar tissue thickness and plantar pressures were measured at 3, 6, 12, and 24 months postinjection. RESULTS: At 12 months, the plantar tissue thickness in the silicone group had increased by a mean 1.6+/-0.9mm (P=.001), and remained increased at 24 months (1.1+/-0.7mm, P=.003). Peak plantar pressure in the silicone group was reduced at 12 months (-165.0+/-253.5kPa, P=.03), but not at 24 months. There was no change in tissue thickness or peak plantar pressure in the placebo group at 12 and 24 months. The reduction in the pressure time integral (PTI) in the silicone group did not reach significance at 12 months (-.71+/-1.17kPa/s, P=.055). Although PTI returned to baseline at 24 months for the silicone group, it was significantly increased in the placebo group (.64+/-.37kPa/s, P=.043), suggesting that silicone may still exhibit some pressure-reducing properties after 24 months. CONCLUSIONS: The results indicate that at 24 months postinjection the cushioning properties of ILS have reduced, suggesting that booster injections may be required in certain patients.     

Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial

BACKGROUND: Valdecoxib, a cyclooxygenase (COX)-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and primary dysmenorrhea. Therapeutic doses of COX-2 specific inhibitors are as effective as nonspecific nonsteroidal anti-inflammatory drugs in reducing inflammatory pain while sparing the gastrointestinal and platelet toxicity associated with nonspecific COX-1 inhibition. OBJECTIVE: The aim of this study was to assess the analgesic efficacy and tolerability of valdecoxib 40 mg/d compared with placebo in the treatment of chronic low back pain. METHODS: This 4-week, prospective, randomized, double-blind placebo-controlled, parallel-group study was conducted at 37 centers across the United States and 5 centers in Canada. Patients aged > or =18 years with chronic low back pain in flare were enrolled. Patients were randomized to receive valdecoxib 40-mg/d or placebo tablets, once daily for 4 weeks. Patients rated low back pain intensity on a visual analog scale and completed the Roland-Morris Disability Questionnaire and the modified Brief Pain Inventory-Short Form (mBPI-SF) at each visit. RESULTS: Two hundred ninety-three patients were enrolled. The valdecoxib group comprised 148 patients (81 women, 67 men; mean [SD] age, 48.6 [13.3] years; mean [SD] body weight, 86.6 [20.9] kg), and the placebo group included 145 patients (85 women, 60 men; mean [SD] age, 48.7 [12.6] years; mean [SD] body weight, 85.6 [19.9] kg). Of the enrolled patients, 249 completed the study: 134 patients (91%) who received valdecoxib and 115 patients (79%) who received placebo. No statistically significant differences in patient baseline characteristics were noted between treatment groups, except in response to 1 mBPI-SF question; patients in the valdecoxib group reported significantly greater interference in relations with other people due to pain than did those in the placebo group (P = 0.048). Changes from baseline in low back pain intensity were significantly greater in valdecoxib-treated patients at each assessment (all, P < 0.001 vs placebo). Pain scores on the mBPI-SF indicated significantly greater pain relief with valdecoxib at each assessment (all, P < or = 0.014 vs placebo). Improvements in mean Roland-Morris Disability Questionnaire score with valdecoxib were significantly greater than with placebo at each assessment (all, P < or = 0.003). Although the overall incidence of adverse events (AEs) was significantly higher among patients receiving valdecoxib than those receiving placebo (35.1% vs 24.1%, respectively; P = 0.042), no significant differences were found between groups for the incidence of any individual AE. Most AEs (89% [77/87 total events]) were mild or moderate in severity. CONCLUSIONS: In this study of patients with chronic low back pain, valdecoxib 40 mg/d provided rapid relief (within 1 week) and consistent relief (over 4 weeks). In addition, significant improvement in function and decreased disability were found with valdecoxib compared with placebo.     

Association Between Clinical Tests Related to Motor Control Dysfunction and Changes in Pain and Disability After Lumbar Stabilization Exercises in Individuals With Chronic Low Back Pain

ObjectiveTo investigate whether clinical tests used to detect motor control dysfunction can predict improvements in pain and disability in patients with chronic nonspecific low back pain (LBP) who have undergone an 8-week lumbar stabilization exercise program.Study DesignA prospective cohort study.SettingOutpatient physical therapy university clinic.ParticipantsSeventy people with chronic nonspecific LBP were recruited, and 64 completed the exercise program (N=64).InterventionsThe lumbar stabilization program was provided twice a week for 8 weeks.Main Outcome MeasuresPain intensity (11-point numerical rating scale) and disability (Roland Morris Disability Questionnaire) and clinical tests, such as the Deep Muscle Contraction (DMC) scale, Clinical Test of Thoracolumbar Dissociation (CTTD), and Passive Lumbar Extension (PLE) test. Univariate and multivariate linear regression models were used in the prediction analysis.ResultsMean changes in pain intensity and disability following the 8-week stabilization program were ?3.8 (95% confidence interval [CI], ?3.2 to ?4.4) and ?7.4 (95% CI, ?6.3 to ?8.5), respectively. Clinical test scores taken at baseline did not predict changes in pain and disability at 8-week follow-up.ConclusionOur findings revealed that the DMC scale, CTTD, PLE test, clinical tests used to assess motor control dysfunction, do not predict improvements in pain and disability in patients with chronic nonspecific LBP following an 8-week lumbar stabilization exercise program.     

Intravenous myocardial contrast echocardiography predicts left ventricular remodeling in patients with acute myocardial infarction.

BACKGROUND: This study evaluated the ability of intravenous myocardial contrast echocardiography (MCE) performed in the setting of acute myocardial infarction for prediction of left ventricular (LV) remodeling. METHODS: Intravenous MCE was performed immediately before, 1 hour, and 24 hours after primary percutaneous transluminal coronary angioplasty (PTCA) in 35 patients with a first myocardial infarction. The MCE was used to define the relative perfusion defect size (in %; relMCD). Two-dimensional echocardiography was performed directly after angioplasty and after 4 weeks to determine LV end-diastolic volumes (LVEDV). The increase in LVEDV at 4 weeks defined a remodeling (> 15% increase) and a nonremodeling group (< or = 15% increase). RESULTS: Patients with remodeling had larger relMCD before (22.0 +/- 16.1 vs 8.0 +/- 11.9, P =.015), 1 hour (20.0 +/- 13.0 vs 4.9 +/- 11.6, P =.001), and 24 hours after PTCA (22.9 +/- 14.1 vs 1.2 +/- 2.8, P <.001). There was a significant correlation between relMCD 24 hours after PTCA and the increase in LVEDV at 4 weeks (r = 0.648; P <.001). Receiver operating characteristic (ROC) curve analysis revealed a relMCD at 24 hours of 5.1% or more to predict remodeling with a sensitivity of 94% and a specificity of 87% (area under ROC curve = 0.917; SE = 0.054). Multivariate analysis demonstrated relMCD at 24 hours to be the only predictor of remodeling (odds ratio = 173.4; P =.022). CONCLUSION: The size of the persistent MCE perfusion defect after revascularization for acute myocardial infarction has a high predictive value for LV remodeling during a 4-week follow-up period.