Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain

ContextWe recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose.ObjectivesTo report the consistency of efficacy, tolerability, and patient acceptability of FPNS vs. IRMS.MethodsPatients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Those who completed an open-label titration phase (n = 84) continued to a DB/DD phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). Pain intensity (PI) and pain relief scores were assessed. Patient acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments.ResultsPer-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful pain relief (P < 0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P < 0.01) and 60 (P < 0.05) minutes. Patients were “satisfied/very satisfied” with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of patients withdrew from titration because of AEs; no significant nasal effects were reported.ConclusionThis study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP.     

Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty: A randomized,placebo-controlled,double-blind study

BackgroundInstillation of local anesthetics into a surgical site has been gaining popularity in post-operative pain management.AimTo determine whether continuous intra-articular infusion of bupivacaine via pain-control infusion pumps (PCIP) enhances and sustains analgesia after total hip arthroplasty (THA).MethodsNinety-two patients undergoing THA were randomized to receive continuous intra-articular infusion of either 0.5% bupivacaine or 0.9% normal saline at a flow rate of 2 mL/h via a PCIP for 48 h. The primary outcome measure was pain intensity on Visual Analogue Scale (VAS) scores in the first 72 h. Other measures included time to first rescue dose of narcotics, amount of narcotic use, presence of adverse events, length of hospital stay, and hip function evaluated with the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index.ResultsDespite a longer time to first narcotic rescue (56 versus 21 min, p < 0.0001) in patients receiving bupivacaine, the two groups did not differ significantly in overall pain relief (p = 0.54). A lower VAS score was found only at time 0 and 2 h; no difference in VAS score was noted at any other time point. Additionally, no difference was found in terms of amount of narcotic use, incidence of adverse events, hospitalization days, and the WOMAC score.ConclusionContinuous intra-articular infusion of 0.5% bupivacaine at 2 mL/h via a PCIP does not provide sustained post-operative pain relief in patients undergoing THA.     

A spicamycin derivative (KRN5500) provides neuropathic pain relief in patients with advanced cancer: a placebo-controlled, proof-of-concept trial

ContextNeuropathic pain in patients with cancer can be difficult to treat effectively.ObjectivesThe purpose of the study was to determine safety and efficacy of KRN5500, a novel, spicamycin-derived, nonopioid analgesic agent, in patients with advanced cancer and neuropathic pain of any etiology.MethodsThe study was a Phase 2a, multicenter, double-blind, placebo-controlled, dose escalation clinical trial. Patients with refractory neuropathic pain and advanced cancer were randomly assigned 2:1 to receive a maximum of eight single escalating doses of KRN5500 or placebo, ranging from 0.6 to 2.2 mg/m². The primary objective was safety and tolerability. The secondary objective was efficacy, measured by change in average pain intensity on a 0–10 numeric rating scale administered one week after the patient’s final dose.ResultsNineteen patients received treatment (KRN5500 n = 12; placebo n = 7). The most frequently reported adverse events were gastrointestinal symptoms, which were more frequent and severe with KRN5500 than placebo; two (17%) KRN5500 patients discontinued the study because of nausea and vomiting. At study endpoint, KRN5500 exhibited a significant median decrease in pain intensity from baseline of 24% compared with 0% for placebo (P = 0.03). The median for largest weekly reduction in target pain intensity was 29.5% for KRN5500 and 0% for placebo patients (P = 0.02).ConclusionThis proof-of-concept study for KRN5500 in patients with advanced cancer and any type of neuropathic pain found gastrointestinal adverse events to be the predominant safety concern. The results also provided the first indication of clinical and statistical efficacy in reducing pain intensity.     

Extracorporeal shock wave therapy for treating dyspareunia: A prospective,randomized, double-blind,placebo-controlled study

BackgroundDyspareunia is a genital pain during or after penile-vaginal sexual intercourse. It is a painful spasm of the pelvic muscles that partly or entirely disables vaginal penetration.ObjectivesWe examined the effect of extracorporeal shock wave therapy (ESWT) on idiopathic non-organic dyspareunia in women. A prospective, randomized, double-blind, placebo-controlled study was conducted.MethodsThe study included 62 women who reported dyspareunia. Patients in the treatment and placebo groups received ESWT perineally weekly for 4 consecutive weeks; placebo patients received placebo stand-off treatment. The grade of dyspareunia was estimated by using the Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS) before and after treatment. Follow-ups were conducted 1, 4 and 12 weeks after the final ESWT session.ResultsThe study included 61 women. The treatment but not placebo group differed by the Marinoff Dyspareunia Scale and VAS. Differences before and after treatment within groups were all P < 0.001 and between groups, P < 0.001. Pain reduction was always > 30%. The effect sizes were both large: Marinoff 0.825 and VAS 0.883.ConclusionsESWT significantly reduced subjective pain in our women treated for dyspareunia.     

Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial

AimTo evaluate the effect of topical formulation of Rosa damascena Mill. (R. damascena) oil on migraine headache, applying syndrome diffrentiation model.Methods and materialsForty patients with migraine headache were randomly assigned to 2 groups of this double-blind, placebo-controlled cross-over trial. The patients were treated for the first 2 consecutive migraine headache attacks by topical R. damascena oil or placebo. Then, after one week of washout period, cross-over was done. Pain intensity of the patients' migraine headache was recorded at the beginnig and ten-sequence time schadule of attacks up to 24 h. In addition, photophobia, phonophobia, and nausea and/or vomitting (N/V) of the patients were recorded as secondary outcomes. Finally, gathered data were analysed in a syndrome differentiation manner to assess the effect of R. damascena oil on Hot- and Cold-type migraine headache.ResultsMean pain intensity of the patients' migraine headache in the different time-points after R. damascena oil or placebo use, was not significantly different. Additionally, regarding mean scores of N/V, photophobia, and phonophobia severity of the patients, no significant differences between the two groups were observed. Finally, applying syndrome differentiation model, the mean score of migraine headache pain intensity turned out to be significantly lower in patients with “hot” type migraine syndrome at in 30, 45, 60, 90, and 120 min after R. damascena oil application compared to “cold” types (P values: 0.001, 0.001, <0.001, <0.001, and 0.02; respectively).ConclusionIt seems that syndrome differentiation can help in selection of patients who may benefit from the topical R. damascena oil in short-term relief of pain intensity in migraine headache. Further studies of longer follow-up and larger study population, however, are necessitated for more scientifically rigorous judgment on efficacy of R. damascena oil for patients with migraine headache.     

Can Kinesio Taping® influence the electromyographic signal intensity of trunk extensor muscles in patients with chronic low back pain? A randomized controlled trial

BackgroundThe evidence of the influence of Kinesio Taping® in changing electromyographic signal intensity of the lumbar musculature in patients with chronic non-specific low back pain (LBP) is very sparse.ObjectivesTo evaluate if Kinesio Taping® changes the electromyographic signal intensity of the longissimus and iliocostalis muscles in patients with chronic non-specific LBP.MethodsProspectively registered, three-arm randomized controlled trial with a blinded assessor. Patients were randomly allocated to the following interventions: 1) Kinesio Taping® Group (n = 21), where patients received the tape according to the manufacturer's manual; 2) Placebo Group (i.e. normal surgical tape) (n = 21); and 3) Non-treatment control Group (n = 21). Assessments were performed at baseline, immediately after, and 30 min after the intervention. The primary outcome was muscle activity of the iliocostalis and longissimus muscles as measured by surface electromyography. The secondary outcome was pain intensity (measured with a 0–10 Numerical Rating Scale). The effects of treatment were calculated using linear mixed models.ResultsA total of 63 patients were recruited. Follow up rate was high (98.4%). Patients were mostly women with moderate levels of pain and disability. Kinesio Taping® was better than the control and placebo groups in only 4 of 96 statistical comparisons, likely reflective of type I error due to multiple comparisons. No statistically significant differences were identified for the immediate reduction in pain intensity between groups.ConclusionKinesio Taping® did not change the electromyographic signal intensity of the longissimus and iliocostalis muscles or reduce pain intensity in patients with chronic low back pain.Clinicaltrials.gov: NCT02759757 (https://clinicaltrials.gov/ct2/show/NCT02759757)     

The effect of oxcarbazepine in peripheral neuropathic pain depends on pain phenotype: A randomised,double-blind,placebo-controlled phenotype-stratified study

In neuropathic pain it has been suggested that pain phenotype based on putative pain mechanisms may predict response to treatment. This was a randomised, double-blind, placebo-controlled, and phenotype-stratified study with 2 6-week treatment periods of oxcarbazepine (1800-2400 mg) and placebo. The primary efficacy measure was change in median pain intensity between baseline and the last week of treatment measured on an 11-point numeric rating scale, and the primary objective was to compare the effect of oxcarbazepine in patients with and without the irritable nociceptor phenotype as defined by hypersensitivity and preserved small nerve fibre function determined by detailed quantitative sensory testing. Ninety-seven patients with peripheral neuropathic pain due to polyneuropathy, surgical or traumatic nerve injury, or postherpetic neuralgia were randomised. The intention-to-treat population comprised 83 patients: 31 with the irritable and 52 with the nonirritable nociceptor phenotype. In the total sample, oxcarbazepine relieved pain of 0.7 points (on a numeric rating scale 0-10; 95% confidence interval [CI] 0.4-1.4) more than placebo (P = 0.015) and there was a significant interaction between treatment and phenotype of 0.7 (95% CI 0.01-1.4, P = 0.047). The number needed to treat to obtain one patient with more than 50% pain relief was 6.9 (95% CI 4.2-22) in the total sample, 3.9 (95% CI 2.3-12) in the irritable, and 13 (95% CI 5.3-∞) in the nonirritable nociceptor phenotype. In conclusion, oxcarbazepine is more efficacious for relief of peripheral neuropathic pain in patients with the irritable vs the nonirritable nociceptor phenotype.     

Scrambler Therapy May Relieve Chronic Neuropathic Pain More Effectively Than Guideline-Based Drug Management: Results of a Pilot,Randomized, Controlled Trial

ContextNeuropathic pain is common, disabling, and often difficult to treat.ObjectivesTo compare guideline-based drug management with Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device.MethodsA clinical trial with patients randomized to either guideline-based pharmacological treatment or Scrambler therapy for a cycle of 10 daily sessions was performed. Patients were matched by type of pain including postsurgical neuropathic pain, postherpetic neuralgia, or spinal canal stenosis. Primary outcome was change in visual analogue scale (VAS) pain scores at one month; secondary outcomes included VAS pain scores at two and three months, pain medication use, and allodynia.ResultsFifty-two patients were randomized. The mean VAS pain score before treatment was 8.1 points (control) and 8.0 points (Scrambler). At one month, the mean VAS score was reduced from 8.1 to 5.8 (?28%) in the control group, and from 8 to 0.7 points (?91%) in the Scrambler group (P < 0.0001). At two and three months, the mean pain scores in the control group were 5.7 and 5.9 points, respectively, and 1.4 and 2 points in the Scrambler group, respectively (P < 0.0001). More relapses were seen in polyradicular pain than monoradicular pain, but retreatment and maintenance therapy gave relief. No adverse effects were observed.ConclusionIn this pilot randomized trial, Scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based drug management.     

The analgesic effect of magnetic acupressure in cancer patients undergoing bone marrow aspiration and biopsy: a randomized, blinded, controlled trial

ContextBone marrow aspiration and biopsy (BMAB) is a frequently performed and painful procedure.ObjectivesTo evaluate the efficacy of magnetic acupressure in reducing pain in cancer patients undergoing BMAB.MethodsCancer patients without previous acupuncture or acupressure experience were stratified by the number of prior BMAB and randomized to having magnetic acupressure delivered to either the large intestine 4 (LI4) acupoint or a sham site. The primary study endpoint was the patient’s pain intensity rating during the procedure using a visual analogue scale (VAS).ResultsSeventy-seven eligible patients received magnetic acupressure: 37 were randomized to treatment at the LI4 site arm and 40 at the designated sham site arm. There was no significant difference between the median pain scores of patients treated at the LI4 site and the sham site (P = 0.87). However, severe pain (VAS ≥ 7) was reported in only one patient (2.7%) treated at the LI4 site compared with eight patients (20%) at the sham site (P = 0.03). No patients experienced significant magnetic acupressure-related toxicities.ConclusionMagnetic acupressure at the LI4 acupoint requires minimal training and expense and is well tolerated. Although its use did not significantly reduce median pain scores in patients undergoing BMAB, it does appear to reduce the proportion of patients with severe pain associated with this invasive procedure.     

The Role of a Low-Dose Ketamine-Midazolam Regimen in the Management of Severe Painful Crisis in Patients With Sickle Cell Disease

ContextAcute pain is one of the main causes of hospital admission in sickle cell disease, with variable intensity and unpredictable onset and duration.ObjectivesWe studied the role of a low-dose intravenous (IV) ketamine-midazolam combination in the management of severe painful sickle cell crisis.MethodsA retrospective analysis was performed with data from nine adult patients who were admitted to the intensive care unit with severe painful sickle cell crises not responding to high doses of IV morphine and other adjuvant analgesics. A ketamine-midazolam regimen was added to the ongoing opioids as an initial bolus of ketamine 0.25 mg/kg, followed by infusion of 0.2–0.25 mg/kg/h. A midazolam bolus of 1 mg followed by infusion of 0.5–1 mg/h was added to reduce ketamine emergence reactions. Reduction in morphine daily requirements and improvement in pain scores were the determinants of ketamine-midazolam effect. The t-tests were used for statistical analysis.ResultsNine patients were assessed, with mean age of 27 ± 11 years. Morphine requirement was significantly lower after adding the IV ketamine-midazolam regimen. The mean ± SD IV morphine requirement (milligram/day) in the pre-ketamine day (D0) was 145.6 ± 16.5, and it was 112 ± 12.2 on Day 1 (D1) of ketamine treatment (P = 0.007). The Numeric Rating Scale scores on D0 ranged from eight to ten (mean 9.1), but improved to range from five to seven (mean 5.7) on D1. There was a significant improvement in pain scores after adding ketamine-midazolam regimen (P = 0.01).ConclusionLow-dose ketamine-midazolam IV infusion might be effective in reducing pain and opioid requirements in patients with sickle cell disease with severe painful crisis. Further controlled studies are required to prove this effect.     

A Randomized,Double-Blind,Placebo-Controlled Study of Fentanyl Buccal Tablets for Breakthrough Pain: Efficacy and Safety in Japanese Cancer Patients

ContextRapid-onset opioids for treating breakthrough pain (BTP) in patients with cancer are needed in the Japanese care setting.ObjectivesTo examine the efficacy and safety of fentanyl buccal tablets (FBTs) for treating BTP in Japanese cancer patients.MethodsThis was a randomized, double-blinded, placebo-controlled study. In subjects receiving around-the-clock (ATC) opioids at doses of 30 mg or more to less than 60 mg or 60–1000 mg of oral morphine equivalents (low and high ATC groups), dose titration was started from 50 to 100 μg FBT, respectively. Subjects whose effective dose was identified were randomly allocated to a prearranged administration order of nine tablets (six FBTs and three placebos), one tablet each for nine episodes of BTP (double blinded). Efficacy and safety of FBT were assessed for patients overall, and also for the low and high ATC groups.ResultsA significant difference was observed between FBT and placebo for the primary endpoint of pain intensity difference at 30 minutes. The analgesic onset of FBT was observed from 15 minutes in several secondary variables (e.g., pain relief). Adverse events were somnolence and other events associated with opioids were mostly mild or moderate. Of the low and high ATC group subjects, an effective FBT dose was identified in 72.2% and 73.1%, respectively.ConclusionThe safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.     

The effect of applying pressure to the LIV3 and LI4 on the symptoms of premenstrual syndrome: A randomized clinical trial

ObjectiveTo evaluate the effect of simple acupressure protocol in LIV3, LI4 and placebo points on the quality of life (QOL) in women with premenstrual syndrome (PMS).MethodThis paper reports a randomized, single blinded clinical trial. 97 participants (students in of Hormozgan University of Medical Sciences, Iran) with PMS were allocated to three groups to receive 20 min acupressure on different acupoints for 14 days before menstruation for three consecutive menstrual cycles (training and then two cycles self applied acupressure). The acupoints were LIV3 and LI4; one group received acupressure at a placebo point. Each participant completed the PSST scale (to determine PMS severity), HADS scale (for depression and anxiety), and quality of life SF12.ResultsThe number of people with moderate/severe PMS decreased in LIV3 and LI4 acupressure groups by the second and third cycles compared with the placebo group (p < 0.04).Moreover, depression and anxiety scores significantly decreased in the LIV3 and LI4 groups by the second and third cycles compared with the placebo group (p < 0.05).Analyzing the score of SF12 fields in the second and third cycles showed a significant difference in all dimensions between the intervention and placebo groups. There was no significant difference between LIV3 and LI4 acupressure groups in decrease of PMS symptoms, anxiety and depression and improving SF12scores (p < 0.05).ConclusionPerforming the simple acupressure protocol at LIV3 and LI4 is an effective method to decrease the severity of PMS symptoms, anxiety and depression, and to improve the QOL. Pressure at LIV3 and LI4 appears to be equally effective.     

Characterization of chemosensory alterations in advanced cancer reveals specific chemosensory phenotypes impacting dietary intake and quality of life

ContextTaste and smell (chemosensory) alterations are common and distressing among advanced cancer patients, but their specific nature is poorly described and seldom linked to dietary intake. Details of altered chemosensory perception may help to explain food intake behaviors.ObjectivesOur goal was to characterize chemosensory alterations and their relationship with dietary intake and quality of life (QOL).MethodsAdult advanced cancer patients (n = 192) completed a chemosensory self-assessment questionnaire to characterize changes in their sense of smell and four basic tastes (sweet, sour, salty, and bitter) since the onset of cancer, three-day food record, and QOL questionnaire.ResultsPatients experienced either no alteration in any basic tastes and sense of smell sensations (26% of patients) or one of three altered chemosensory phenotypes: 1) stronger sensations overall (42%), 2) weaker sensations overall (18%), or 3) mixed (some sensations stronger and others weaker, 14%). For individual sensations (sweet, sour, salty, bitter, and smell), stronger sensation was twice more prevalent than weaker sensation (P = 0.035). Patients reporting chemosensory alteration consumed 20%–25% fewer calories per day (P = 0.0018), experienced greater weight loss (P = 0.0036), and had poorer QOL scores (P = 0.0176) compared with patients with no alterations, but results did not vary by chemosensory phenotype. Chemosensory alterations were not related to tumor type (P = 0.884), gender (P = 0.286), or nausea (P = 0.278).ConclusionChemosensory alterations predict dietary intake and QOL; the identification of chemosensory phenotypes provides a rationale to adjust the properties of foods and dietary recommendations in function of the specific nature of these changes.     

Effectiveness of Spiritist “passe” (Spiritual healing) for anxiety levels,depression, pain,muscle tension,well-being,and physiological parameters in cardiovascular inpatients: A randomized controlled trial

BackgroundBiofield therapies, such as laying on of hands, are used in association with Conventional Medicine as Spiritist “passe”, among others. The aim of this study was to evaluate anxiety, depression, pain, muscle tension and well-being, as well as physiological parameters in cardiovascular inpatients submitted to the Spiritist “passe”, sham, and no intervention.MethodsIn the total, 41 cardiovascular inpatients submitted to the Spiritist “passe”, sham, and no intervention during a 10-min period on 3 consecutive days. They were evaluated through anxiety and depression level, pain, the perceptions of muscle tension and well-being and physiological parameters, before and after interventions.ResultsA significant reduction (p = 0.001) in anxiety scores and muscle tension (p = 0.011), improvement of well-being (p = 0.003) and a significant increase in peripheral oxyhemoglobin saturation scores (p = 0.028) were observed in Spiritist “passe” patients, and a significant reduction (p = 0.028) of muscle tension and improvement of well-being (p = 0.045) in sham patients. However, muscle tension reduction (p = 0.003) and improvement of well-being (p = 0.003) were more accentuated in the Spiritist “passe” compared to sham and no intervention.ConclusionsResults suggest that the Spiritist “passe” appeared to be effective, reducing anxiety level and the perception of muscle tension, consequently improving peripheral oxyhemoglobin saturation and the sensation of well-being compared to sham and no intervention in cardiovascular inpatients.     

Lack of Benefit From Paracetamol (Acetaminophen) for Palliative Cancer Patients Requiring High-Dose Strong Opioids: A Randomized,Double-Blind,Placebo-Controlled,Crossover Trial

ContextThe adjunctive use of paracetamol (acetaminophen) with strong opioids has become entrenched practice in palliative care pain management, despite little evidence to support its use.ObjectiveThe study aim was to investigate potential analgesic benefits of 4 g of paracetamol daily for palliative cancer patients requiring high-dose opioids.MethodsThirty-one patients, using at least 200 mg of oral morphine equivalent daily, were recruited to a prospective, double-blinded, randomized, crossover trial. Patients received usual medications plus 4 g of paracetamol or placebo for five days each in random order. Primary outcome, effect on pain, was assessed using daily diaries, including a numerical rating scale (NRS) from zero (no pain) to 10 (unbearable) and recording numbers of breakthrough analgesics. Secondary outcomes—nausea, vomiting, cognitive impairment, constipation, and overall well-being—were assessed using the NRS. Data from the last four days of each treatment were analyzed. Patients also indicated in which part of the study their pain was better controlled.ResultsTwenty-two patients, requiring a median dose of 255 mg of oral morphine equivalent daily, completed the trial. There were no significant order or treatment-by-order interaction effects for any variable; paired t-tests were conducted to investigate change in mean levels on outcome variables with placebo vs. paracetamol. For none of the variables was there a statistically significant difference when assessed with placebo compared with paracetamol. No change approached clinically significant levels, with a mean difference in rated pain of 0.16, and mean difference of 0.42 for a number of breakthrough medications. Fifteen patients were undecided whether paracetamol improved pain.ConclusionsThese data do not support the common practice of adding regular paracetamol daily as an adjunct to high-dose opioids for pain control in cancer patients receiving palliative care.     

Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial

BackgroundShoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome.ObjectiveTo decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture.MethodRandomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0–35 points).ResultsA total of 68 participants were included in the analysis (TA, n = 35; SA, n = 33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported.ConclusionsThe use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.     

Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial

BackgroundProprioceptive neuromuscular facilitation training and general trunk exercises have been applied to treat chronic low back pain patients. However, there is currently little study to support the use of one treated intervention over the other to improve clinical outcomes and balance ability.ObjectiveTo examine the effects of proprioceptive neuromuscular facilitation training on pain intensity, disability and static balance ability in working-age patients with chronic low back pain.MethodsForty-four chronic low back pain participants aged 18–50 years were randomized either to a three-week proprioceptive neuromuscular facilitation training or to a control group receiving general trunk exercises. Pain intensity, disability and static balance ability were measured before and after the three-week intervention.ResultsThe proprioceptive neuromuscular facilitation training intervention showed a statistically significantly greater reduction in pain intensity and improved functional disability than the controls at three weeks (between-group difference: pain intensity 1.22 score, 95% CI: 0.58 to 1.88, p < 0.001; disability 2.23 score, 95% CI: 1.22 to 3.24, p < 0.001. The proprioceptive neuromuscular facilitation training intervention also had statistically better parameters of static balance ability than the control group (between-group difference: ellipse sway area during eye opened and closed conditions 129.09 mm², 95% CI: 64.93 to 175.25, p < 0.01 and 336.27 mm², 95% CI: 109.67 to 562.87, p < 0.05, respectively; the centre of pressure velocity during eye opened and eye closed conditions 6.68 mm/s, 95% CI: 4.41 to 8.95, p < 0.01 and 6.77 mm/s, 95% CI: 4.01 to 9.54, p < 0.01, respectively).ConclusionThe three-week proprioceptive neuromuscular facilitation training provides better pain intensity, disability and static balance ability than general trunk exercises for working-age individuals with chronic low back pain but the effects do not reach the clinical meaningful level. The therapists should consider carefully when making recommendations regarding these interventions, taking into account effectiveness and costs.     

The role of knee joint moments and knee impairments on self-reported knee pain during gait in patients with knee osteoarthritis

BackgroundThe association between high mechanical knee joint loading during gait with onset and progression of knee osteoarthritis has been extensively studied. However, less attention has been given to risk factors related to increased pain during gait. The purpose of this study was to evaluate knee joint moments and clinical characteristics that may be associated with gait-related knee pain in patients with knee osteoarthritis.MethodsSixty-seven participants with knee osteoarthritis were stratified into three groups of no pain (n = 18), mild pain (n = 27), or moderate/severe pain (n = 22) based on their self-reported symptoms during gait. All participants underwent three-dimensional gait analysis. Quadriceps strength, knee extension range of motion, radiographic knee alignment and self-reported measures of global pain and function were also quantified.FindingsThe moderate/severe pain group demonstrated worse global pain (P < 0.01) and physical function scores (P < 0.01) compared to the no pain and the mild pain groups. The moderate/severe pain group also walked with greater knee flexion moments during the midstance phase of gait compared to the no pain group (P = 0.02). Additionally, the moderate/severe pain group demonstrated greater varus knee malalignment (P = 0.009), which was associated with higher weight acceptance peak knee adduction moments (P = 0.003) and worse global pain (P = 0.003) and physical function scores (P = 0.006).InterpretationGreater knee flexion moment is present during the midstance phase of gait in patients with knee osteoarthritis and moderate/severe pain during gait. Additionally, greater varus malalignment may be a sign of increased global knee joint dysfunction that can influence many activities of daily living beyond gait.     

Effect of light pressure stroking massage with sesame (Sesamum indicum L.) oil on alleviating acute traumatic limbs pain: A triple-blind controlled trial in emergency department

ObjectivesDue to adverse effects of common medications used for traumatic pain management, it is crucial to use complementary methods to alleviate this pain. Present study aimed to assess the effect of light pressure stroking massage with topical sesame oil on pain severity of patients with limbs trauma.MethodsThis triple-blinded randomized trial was conducted on 40 patients with upper or lower extremities trauma in emergency department of Busheher Amir Al-Momenian Hospital, Busheher, Iran, in 2015–2016. Patients received a 5 min massage with either liquid paraffin (placebo) or sesame oil on trauma site twice a day for 9 days duration. Pain severity was assessed by visual analogue scale in first day (baseline), 3th, 6th and 9th days of intervention in the both groups.ResultsMean changes of pain severity between two groups was significant in the 6th (−0.20 ± 1.36; P = 0.036) and 9th (−0.36 ± 1.12; P < 0.001) days of intervention. Regarding to intake of diclofenac, no significant difference was seen between sesame oil and placebo groups during 9 days of intervention (575.23 ± 3.11 and 625.13 ± 4.23 respectively, P = 0.601). There were no adverse effects during the study in the both groups.ConclusionMassage with topical sesame oil was associated with significant reduction in pain severity of patients with limbs trauma. Therefore, it is suggested to use this oil on complementary medicine for pain relief due to low cost, easy usage and lack of adverse effects.