Mean Baseline Visual Analogue Scale Research Articles

Safety and clinical efficacy of microwave ablation combined with percutaneous vertebroplasty in the treatment of multisegmental spinal metastases.

To evaluate the safety and efficacy of microwave ablation (MWA) combined with percutaneous vertebroplasty (PVP) in the treatment of multisegmental (2-3 segments) osteolytic spinal metastases. This study comprised a retrospective analysis of data from 20 patients with multisegmental (2-3 segments) osteolytic spinal metastases who received MWA combined with PVP. The visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, Quality of Life Questionnaire-Bone Metastases 22 (QLQ-BM22), and local recurrence before and after the operation were measured. The occurrence of complications was observed to evaluate safety. All operations were completed successfully with no serious complications. Transient nerve injury occurred in two cases, but recovered after symptomatic treatment. The bone cement leakage rate was 13.9% (6/43). The mean baseline VAS scores were 7.25 ± 0.91 before treatment and 7.25 ± 0.91, 3.70 ± 1.12, 2.70 ± 0.73, 2.40 ± 0.68, 2.25 ± 0.71, and 2.70 ± 0.92 at 1 day, 1 week, 1, 3, and 6 months after treatment; all values were significantly lower (P < 0.001). The mean baseline ODI score decreased from 56.90 ± 9.74 before treatment to 41.90 ± 7.09, 38.10 ± 7.93, and 38.80 ± 10.59 at 1, 3, and 6 months after treatment, respectively; all values were significantly lower (P < 0.001). The average QLQ-BM22 baseline score decreased from 54.10 ± 5.36 before treatment to 44.65 ± 5.22, 43.05 ± 4.78, 42.30 ± 4.06, and 42.15 ± 5.47 at 1 week, 1, 3, and 6 months after treatment; all values were significantly lower (all P < 0.001). The postoperative survival time of all patients was >6 months. In three patients, four vertebral segments recurred 6 months after operation. MWA combined with PVP is a safe and effective treatment for multisegmental osteolytic vertebral metastases that can effectively relieve pain, improve spinal function, improve quality of life, and delay tumor progression. However, it is a long operation, necessitating good preoperative preparation and effective intraoperative pain relief measures.

Estimating the Minimal Clinically Important Difference on the Visual Analogue Scale for Carpometacarpal Thumb Joint Osteoarthritis.

The minimal clinically important difference (MCID) is the smallest perceived treatment effect that patients deem clinically significant. There is currently no agreement on an appropriate MCID for the pain visual analogue scale (VAS) in the context of thumb osteoarthritis (OA). We approximated MCIDs using a distribution-based approach that pooled standard deviations (SDs) associated with baseline mean values of the pain VAS (0-100 mm). We extracted the data from randomized controlled trials (RCTs) included in a systematic review of adults with long-term OA of the thumb. We excluded RCTs that did not report baseline SD values. The MCIDs were derived at 0.4 and 0.5 SDs of the pooled SD and compared with previously published MCIDs for the pain VAS in OA. A total of 403 patients were pooled from 7 RCTs for the analysis. The mean baseline VAS pain score was 5.6 cm. We derived an MCID of 0.72 cm at 0.4 SDs and 0.91 cm at 0.5 SDs using baseline SDs. We found that MCIDs derived from a distribution-based approach approximated published MCIDs for the VAS for pain for OA in the knee and hip. The authors propose that a change of 0.7 to 0.9 cm on the VAS is clinically meaningful in the context of long-term OA of the thumb.

Ozone disc nucleolysis in the management of herniated lumbar intervertebral disc: A retrospective analysis.

Various minimally invasive surgeries were proposed for the management of herniated lumbar intervertebral disc. However, to choose optimal treatment modality to maximize patient benefit is a clinical challenge for the treatment givers. The objective was to study the role of ozone disc nucleolysis in the management of herniated lumbar intervertebral disc by retrospective analysis. We conducted a retrospective analysis of patients of lumbar disc herniation treated by ozone disc nucleolysis during May 2007-May 2021. There were total of 2089 patients with 58% of males and 42% of females. The age ranged from 18 to 88 years. Outcome was measured on the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) along with modified MacNab method. The mean baseline VAS score was 7.73, which became 3.07 at 1 month, 1.44 at 3 months, 1.42 at 6 months, and 1.36 at 1 year. Similarly, the mean ODI index was 35.92 at baseline, which improved to 9.17 at 1 month, 6.14 at 3 months, 6.10 at 6 months, and 6.09 at 1 year. VAS score and ODI analysis was found to be statistically significant with P < 0.05. Modified MacNab criterion showed successful treatment outcome in 85.6% with excellent recovery in 1161 (55.58%), good recovery in 423 (20.25%), and fair recovery in 204 (9.77%). Mediocre or no recovery was seen in the remaining 301 patients amounting to a 14.40% failure rate. This retrospective analysis confirms that ozone disc nucleolysis is an optimally effective and least invasive treatment option for herniated lumbar intervertebral disc with a significant reduction in disability.

Abstract No. : ABS0544 : A prospective randomised study comparing computerised tomography guided neurolytic coeliac plexus block with oral analgesic therapy in the treatment of severe pain due to pancreatic cancer

Background and Aims:Neurolytic Coeliac Plexus block (NCPB) is a promising treatment modality apart from commonly practiced oral analgesicTherapy (OAT) for pancreatic cancer pain. The aim was to compare the efficacy of NCPB with OAT in the treatment of severe pancreatic cancer pain.Methods:Forty four patients with severe upper abdominal pain (Visual Analogue Scale(VAS) >7/10) due to unresectable pancreatic cancer were allocated randomly and equally in either NCPB group or OAT group. Patients in NCPB group were treated with 99.99% ethanol as neurolytic agent for coeliac plexus block under Computerised Tomography (CT) guidance. OAT group patients were treated with morphine tablets orally. Patients’pain intensity and opioid analgesic consumption (Oral Morphine equivalent (OME)) were assessed at day 1, 7 and 28 after the intervention. Oral morphine tablets were started in the NCPB group when the patients had severe pain after the NCPB intervention.Results:Mean baseline VAS pain scores were 8.2 and 7.9 for NCPB group and OAT group, respectively. At day 1, 7 and 28, pain scores of NCPB group were significantly lower than that of OAT group (P<0.05), 1.4±0.7 versus 3.9±0.8, 1.7±0.6 versus 3.3±0.5 and 2.1±0.8 versus 3.0±0.7, respectively(table 1). At day 1, 7 and 28, OME (mg/day) values in NCPB group were significantly lower than in OAT group (P<0.05), 8.1±0.2 versus 39.5±0.7, 12.2±0.8 versus 48.3±0.4 and 14.6±0.5 versus 57.1±0.8, respectively (table 2).Table 1Changes in visual analogue scale valuesVisual analogue scale (0-10) (mean values) Day 0Day 1Day 7Day 28NCPB group8.21.41.72.1OAT group7.93.93.33.0Table 2Oral morphine equivalent (mg/day) consumptionOral morphine equivalent (mg/day) (mean values) Day 1Day 7Day 28NCPB group8.112.214.6OAT group39.548.357.1Conclusion:CT guided NCPB is an effective treatment modality for controlling severe upper abdominal pain due to unresectable pancreatic cancer. Celiac plexus, block, pancreatic cancer

Abstract No. : ABS2211

Background & Aims:Neurolytic celiac plexus block (NCPB) is a promising treatment modality apart from commonly practiced oral analgesic therapy (OAT) for pancreatic cancer pain. This study aimedto compare the efficacy of NCPB with OAT in the treatment of severe pancreatic cancer pain.Methods:Forty four patients with severe upper abdominal pain Visual Analogue Scale (VAS) score ≥7/10, due to unresectable pancreatic cancer were allocated randomly and equally in either NCPB group or OAT group. Patients in NCPB group were treated with 99.99% ethanol as a neurolytic agent for celiac plexus block under computerised tomography(CT) guidance. Patients in OAT group were treated with morphine tablets given orally. Patients’ pain intensity (VAS) and opioid analgesic consumption (oral morphine equivalent (OME)) were assessed at day 1, 7 and 28 after the intervention. Oral Morphine tablets were started in the NCPB group when patients developed severe pain after the intervention.Results:Mean baseline VAS scores were 8.2 and 7.9 for NCPB group and OAT group, respectively. At day 1, 7 and 28, pain scores of NCPB group were significantly lower than OAT group (P<0.05), 1.4±0.7 versus 3.9±0.8, 1.7±0.6 versus 3.3±0.5 and 2.1±0.8 versus 3.0±0.7, respectively. At day 1, 7 and 28, OME (mg/day) values of NCPB group were significantly lower than OAT group (P<0.05), 8.1±0.2 versus 39.5±0.7, 12.2±0.8 versus 48.3±0.4 and 14.6±0.5 versus 57.1±0.8, respectively.Conclusion:CT guided NCPB is an effective treatment modality for controlling severe upper abdominal pain due to unresectable pancreatic cancer.

Effectiveness of intra-articular hyaluronic acid versus corticosteroids in knee osteoarthritis: a comparative study

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Osteoarthritis (OA) is the largest cause of disability worldwide and the most common cause of knee discomfort. OA is a chronic, progressive joint disease marked by articular cartilage deterioration and secondary hyperosteogeny. OA affects 35 percent of those over the age of 65 and produces considerable pain in the knee joint. The patient with OA not only suffers from chronic pain, stiffness, and reduced movement, physical and/or mental co-morbidity, but also has a direct impact on their quality of life.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 72 patients with symptomatic osteoarthritis of unilateral knee joint (pain &amp;gt;3 months) were included in the present study. They were randomly divided into two groups; group A (n=36) included patients who were given intra-articular injection hyaluronic acid and group B (n=36) included those who were given intra-articular corticosteroid injection. All the data was compared both within the group as well as with one another at different follow up time.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; There was no significant difference in the basic demographic distribution in both groups. Female sex predilection was seen in the present study. In patients receiving hyaluronic acid (HA), mean baseline visual analog scale (VAS) score was noted to be 7.45±1.4. Then at 2 weeks, 6 weeks, 3 months and 6 months follow up the mean VAS score was 3.4±1.3, 2.78±1.1, 3.71±1.4 and 3.90±1.2; p&amp;lt;0.05).&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Steroids provide an acute symptomatic relief but their benefits are short lasting. On the other hand, HA provides long lasting therapeutic pain relief.&lt;/p&gt;

Ozone disc nucleolysis in cervical intervertebral disc herniation: A nonrandomized prospective analysis in 246 patients

ABSTRACTBackground:Inherent complications associated with surgery and limited success of percutaneous minimally invasive procedures make researches wanting for an ideal treatment for cervical disc herniation.Objective:We prospectively study the role of ozone disc nucleolysis in cervical intervertebral disc herniation.Patients and Methods:From January 2008 to December 2020, we prospectively study 246 consecutive patients of cervical disc herniation treated by a single session of intradiscal injection of ozone–oxygen mixture (ozone disc nucleolysis). There were 55% of females and 45% of males. Age ranged from 28 to 68 years with a mean of 47. The outcome was measured on visual analog scale (VAS) scale and neck disability index (NDI) along with Mcnab method.Results:The mean baseline VAS score was 7.87 which became 3.09 at 1 month, 1.42 at 3 months, 1.40 at 6 months, and 1.35 at 1 year. The mean NDI was 36.27 at baseline which improved to 9.24 at 1 month, 6.25 at 3 months, 6.20 at 6 months, and 6.22 at 1 year. This was found to be significant with P < 0.05. Modified McNab criterion showed excellent recovery in 138 (56.10%), good recovery in 50 (20.32%), and fair recovery in 22 (8.94%), resulting in a successful rate of 85.36%. Mediocre recovery was seen in the remaining 36 patients amounting to a 14.64% failure rate.Conclusion:This study showed that ozone disc nucleolysis significantly reduces the pain related to cervical disc herniation along with a significant reduction in disability.

Flupirtine in the Management of Taxane-induced Pain in Cancer Patients.

Objectives:Paclitaxel and docetaxel are two commonly used chemotherapeutic agents in the treatment of various types of cancers. However, debilitating taxane-induced arthralgia and myalgia are among the most common adverse reactions associated with taxanes, which has greatly influenced medical practitioners. Most of the mild and moderate analgesics were found to be less effective in the management of taxane induced pain. So we used flupirtine, a non-opioid analgesic, in the treatment of taxane-induced pain.Materials and Methods:In this study, we analysed the baseline pain score and follow-up data of 60 patients receiving a taxane-based chemotherapy regimen. Baseline data of these study populations experiencing significant taxane-induced pain were compared with follow-up data after treating them with analgesic flupirtine (200 mg/day). The baseline and follow-up data representing pain were assessed with the help of the Visual Analogue Scale (VAS), and the quality of life was determined using the Brief Pain Inventory (BPI) scale questionnaire.Results:The mean baseline and follow-up VAS score was compared using paired sample t-test, which showed a significant reduction in taxane-induced pain after treatment with flupirtine (P < 0.001). Similarly, the mean BPI score representing the quality of life before and after treatment with flupirtine was compared, and a notable improvement in quality of life was seen after treatment with flupirtine. The mean and follow-up data of aspartate aminotransferase and alanine aminotransferase levels of patients were also compared to assess the adverse drug reaction profile of the drug, and the analyzed data was found to be statistically insignificant (no significant liver toxicity) which indicates that drug can be used effectively for a period of <2 weeks.Conclusion:We believe that flupirtine can be used as an effective analgesic in dire situations where patients require opioid analgesics for the management of taxane-induced pain, provided that the drug is given for <2 weeks to avoid drug-related hepatotoxicity.

The medium to long-term effects of two-duct ligation for excessive drooling in neurodisabilities, a cross-sectional study

This study aims to evaluate the medium to long-term (1-12 years) effectiveness of two-duct ligation (2-DL) in patients with nonprogressive neurodisabilities. Main outcomes included a Visual Analogue Scale (VAS), Drooling Severity (DS) and Drooling Frequency (DF), collected at baseline, 32 weeks postintervention and 1-12 years postintervention. Secondary outcomes were adverse events (AEs), and satisfaction. Forty-two patients were analyzed (mean age 17 years, mean baseline VAS 82). VAS decreased significantly from baseline to long-term (n=30. Mean difference -36.5, CI -47.0 to -26.0, p≤0.001; -26.1, CI -36.2 to -15.9, p≤0.001). However, long-term VAS significantly increased compared to VAS at 32 weeks (+10.4, CI 1.0-19.8, p=0.031). Out of 42 patients, 64% would recommend 2-DL to peers. There is a significant subjective 2-DL effect on drooling severity in the medium to long-term as reported by patients and caregivers, but there is also a certain degree of recurrence in this time span, and 33% of the patients required subsequent treatment. However, the majority of patients and/or caregivers would recommend 2-DL to peers.

Surgical Outcome of Anterior Cervical Decompression and Fusion in Patients with Cervical Spondylotic Myelopathy and Radiculopathy in Terms of Improvement of Pain

Objective: Cervical spondylosis is a common degenerative condition leading to compression of nerve roots or spinal cord, causing radiculopathy or myelopathy. Anterior cervical decompression and fusion (ACDF) techniques are commonly recognized procedures in treating axial cervical spine pain and upper extremity radicular discomfort. The study analyzed the surgical outcome of anterior cervical decompression and fusion (ACDF) in cervical spondylotic myelopathy (CSM) and radiculopathy patients in terms of pain improvement.&#x0D; Material and Methods: This descriptive case series analysis was performed at the Neuro Surgery department, Lady Reading Hospital Peshawar. A total of 146 patients between age 18 – 65 years meeting the inclusion criteria underwent anterior decompression &amp;post-procedure improvement in pain of neck and arm/shoulder was determined using patient reported outcome (PRO) measure, namely visual analog scale (VAS) of 0-10 and a final outcome that is an improvement of pain, i.e., Mild to no pain (VAS score ?3) was considered after 12 months.&#x0D; Results: The mean age was 52 years ± 8.273. As regards gender distribution, 78% of patients were male, while 22% were female. The mean baseline VAS score was 6.5 ± 2.37, mean postoperative VAS score was 3.5 ± 1.161 with a mean point improvement in pain of 3.0 points (p-value &lt; 0.05). 80% of patients had shown improvement in reducing pain, while 20% did not have shown any improvement.&#x0D; Conclusion: This study revealed that independent of symptoms duration and presentation, patients reported dramatic improvements in neck and arm pain after ACDF.

Superior hypogastric plexus block as an effective treatment method for endometriosis-related chronic pelvic pain: an open-label pilot clinical trial

We aimed to investigate the effect of superior hypogastric plexus (SHP) block on pain relief and quality of life of patients with refractory endometriosis. Sixteen patients with refractory endometriosis underwent SHP block. The outcome measures included visual analogue scale (VAS) for chronic pelvic pain, VAS for dysmenorrhoea, and VAS for dyspareunia. The short-form endometriosis health profile (EHP-5) was used to measure quality of life. All the outcome measures were evaluated at weeks 0, 1, 4, 12 and 24. The mean baseline VAS scores significantly improved after the SHP block (p < .001 for all). The mean overall EHP-5 score also significantly improved from 54.3 ± 18.2 to 24.6 ± 13.3 (p < .001). The positive effects of SHP were not diminished over time. No serious adverse effect was noticed in any of the patients. Preliminary results suggest that SHP block could be used as an effective method in pain control and improvement of quality of life in refractory endometriosis. IMPACT STATEMENT What is already known on this subject? Safety and efficacy of SHP block in the treatment of CPP has been revealed in earlier investigations. However, the efficacy of SHP block for pain management in patients with refractory endometriosis has not been investigated in earlier investigations. What do the results of this study add? SHP block is an effective method for pain control and improvement of quality of life in patients with refractory endometriosis. The positive effects of this treatment did not diminish over 24-weeks follow-up of the study. No serious adverse effect was noticed in any of the patients. What are the implications of these findings for clinical practice and/or further research? Preliminary results suggest that SHP block could be used safely and effectively for controlling pain and improvement of quality of life in patients with refractory endometriosis.

Role of triple injection of Platelet rich plasma as a therapeutic strategy for Osteoarthritis knee: A single blind prospective, hospital based study

Background & Aim After evolving as a promising treatment option for tendinopathies & sports injuries, there have been encouraging reports of using platelet rich plasma (PRP) in the treatment of osteoarthritis (OA) knees.However still there is no general consensus on the number and frequency of PRP injections, which would lead to favourable outcome.The present study was undertaken to evaluate the role of 3 intraarticular (IA) PRP injections given 1 month apart, in patients of OA knee. Methods, Results & Conclusion Methods The present study included 50 patients (92 knees) consisting of 30 females and 20 males presenting to Teerthanker Mahaveer Medical College, between September 2017 to June 2018 having Kellgren-Lawrence (KL) grades I, II & III OA knees.3 intra articular injections of 3 ml PRP were given in the affected knee at an interval of 1 month each.Western Ontario and Mc Master Scores (WOMAC) and Visual analog scale (VAS) for pain were measured before the 1st injection (baseline score) and then before the 2nd and 3rd injection.Subsequent follow up was done at 3, 6& 12 months after the 3rd injection. Results 6 patients were lost to follow up.The mean age was 53.27years.The mean BMI (SD) was 31.8 (4.6).The mean baseline WOMAC score and VAS was 56.30 and 6.09 respectively.The mean WOMAC & VAS score was 48.87 & 5.24 before the 2nd injection and 38.99 & 4.19 before the 3rd injection respectively.The mean WOMAC score and VAS at 3, 6& 12 months of follow up were 31.01 & 3.431, 29.86 & 3.29, 20.16 & 2.09 respectively(Figure 1,2).The mean pain scores decreased at each follow-up (11.96 at baseline,3.02 at final follow up).The trend of other secondary WOMAC parameters, i.e. stiffness (3.78 at baseline,1.78 at final follow up) & physical function (35.74 at baseline,15.36 at final follow up) was noted to be similar to the pain(Figure 3).This shows statistically significant improvement in the studied variables (p Conclusion The results of our study highlight that 3 injections of PRP given at an interval of 1 month are both safe and effective as a modality of treatment for KL grade I & II & III OA knees.

Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA).

IntroductionInhaled low-dose methoxyflurane is approved in Europe for emergency relief of moderate-to-severe trauma-related pain in adults, but data versus active comparators are sparse. The phase IIIb Methoxyflurane in Emergency Department in ITAly (MEDITA) trial investigated the analgesic efficacy, practicality and safety of methoxyflurane versus standard analgesic treatment (SAT) for acute trauma pain.MethodsThis was a randomised, active-controlled, parallel-group, open-label trial conducted in 15 Italian emergency units. Adults with limb trauma and pain score ≥ 4 on numerical rating scale (NRS) were randomised 1:1 to inhaled methoxyflurane 3 mL or SAT [intravenously administered (IV) morphine 0.1 mg/kg for severe pain (NRS ≥ 7); IV paracetamol 1 g or IV ketoprofen 100 mg for moderate pain (NRS 4–6)]. The primary endpoint was overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10 min. Non-inferiority and superiority of methoxyflurane versus SAT were concluded if the upper 95% confidence interval (CI) for the treatment comparison (methoxyflurane–SAT) was less than 1 and less than 0, respectively.ResultsBetween 8 February 2018 and 8 February 2019, 272 patients were randomised (136 per treatment group). A total of 270 patients (mean age 51 years; 49% male; 34% with severe pain; mean baseline VAS 67 mm) were treated and analysed for efficacy and safety. Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference − 5.94 mm; 95% CI − 8.83, − 3.06 mm), moderate pain (− 5.97 mm; 95% CI − 9.55, − 2.39 mm) and severe pain (− 5.54 mm; 95% CI − 10.49, − 0.59 mm). Median onset of pain relief was 9 min for methoxyflurane and 15 min for SAT. Practicality of methoxyflurane treatment was rated “Excellent”, “Very Good” or “Good” by 90% of clinicians vs. 64% for SAT. Adverse events (all non-serious) were reported by 17% of methoxyflurane-treated patients and 3% of SAT-treated patients.ConclusionMethoxyflurane provided superior pain relief to SAT in patients with moderate-to-severe trauma pain and may offer a simple, fast, effective non-opioid treatment option.Trial registrationTrial registered with EudraCT (2017-001565-25) on 2 March 2018 and ClinicalTrials.gov (NCT03585374) on 13 July 2018.FundingMundipharma Pharmaceuticals S.r.l.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01055-9) contains supplementary material, which is available to authorized users.

Exercise-Based VRT Shows Benefits in Balance and Postural Stability in Adult Patients with Unilateral Vestibular Hypofunction

Background and Objective: Vestibular rehabilitation therapy (VRT) is an exercise-based program designed to improve balance function and alleviate problems related to dizziness, including vestibular hypofunction. This study aimed to evaluate the therapeutic effects of VRT exercises on balance function in adults with unilateral vestibular hypofunction (UVH). Methods: Thirty-one patients (mean age: 39.48 (±10.96) years old) with confirmed UVH participated in this study. The VRT program consisted of habituation and adaptation exercises in combination with gait and balance exercises. The handicapping influences of dizziness were measured with a dizziness handicap inventory (DHI) scale to measure the level of respondent’s performance on physical, emotional, and functional dimensions. Visual analogue scale (VAS) was also used to rate the severity of dizziness symptoms. The DHI and VAS scales were assessed pre-intervention and post-intervention at one, two, and four weeks follow-ups after the last rehabilitation session. Results: An analysis of variance showed a significant reduction and a consequent improvement in DHI scores after vestibular exercises in all domains: emotional, physical and functional (p &lt; 0.001). The mean total DHI score significantly decreased by 15 points after one week, 24 points after two weeks and 15 points after four weeks of the last VRT session. The mean baseline VAS score was 7.71 (±0.91) that significantly decreased at one, two, and four weeks post-intervention to 4.81 (±0.73), 3.77 (±0.61), and 3.16 (±0.97), respectively (p&lt;0.001). Conclusion: The exercise-based VRT shows benefits for adult patients with chronic dizziness concerning improvement in the vertigo symptom scale, fall risk, balance and emotional status.

Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA)

Background: Inhaled low-dose methoxyflurane is approved in Europe for emergency relief of moderate-to-severe trauma-related pain in adults, but data versus active comparators are sparse. The Phase IIIb MEDITA trial investigated the analgesic efficacy, practicality and safety of methoxyflurane versus standard analgesic treatment (SAT) for acute trauma pain. Methods: Randomised, active-controlled, parallel-group, open-label trial conducted in 15 Italian emergency units. Adults with limb trauma and pain score ≥4 on Numerical Rating Scale (NRS) were randomised 1:1 to inhaled methoxyflurane 3mL or SAT (intravenous [IV] morphine 0.1mg/kg for severe pain [NRS ≥7]; IV paracetamol 1g or IV ketoprofen 100mg for moderate pain [NRS 4-6]). Primary endpoint was overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10min. Non-inferiority and superiority of methoxyflurane versus SAT were concluded if the upper 95% confidence interval (CI) for the comparison was <1 and <0, respectively. Findings: Between February 8, 2018, and February 8, 2019, 272 patients were randomised (136 per group). 270 patients (mean age 51 years; 49% male; 34% with severe pain; mean baseline VAS: 67mm) were treated and analysed. Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference: -5·94mm; 95% CI: -8·83, -3·06mm), moderate pain ( 5·97mm; 95% CI: 9·55, -2·39mm) and severe pain (-5·54mm; 95% CI: -10·49, -0·59mm). Median onset of pain relief was 9min for methoxyflurane and 15min for SAT. Practicality of methoxyflurane treatment was rated Excellent, Very or Good by 90% of clinicians vs. 64% for SAT. 17% of methoxyflurane-treated patients and 3% of SAT-treated patients reported adverse events (all non-serious). Interpretation: Methoxyflurane provided superior pain relief to SAT in patients with moderate-to-severe trauma pain and may offer a simple, fast, effective non-opioid treatment option. Trial Registration: This trial is registered with EudraCT (2017- 001565-25) and ClinicalTrials.gov (NCT03585374). Funding Statement: The study was funded by Mundipharma Pharmaceuticals srl. Costs for article processing and Open Access were funded by Mundipharma Pharmaceuticals srl. Declaration of Interests: Sebastiano Mercadante, Antonio Voza, Sossio Serra, Germana Ruggiano, Giseppe Carpinteri, Gianfilippo Gangitano, Fabio Intelligente and Andrea Fabbri have nothing to disclose. Elisabetta Bonafede is an employee of the clinical research organisation that conducted the study. Antonella Sblendido, Amedeo Soldi and Alberto Farina are employees of Mundipharma Pharmaceuticals srl. Ethics Approval Statement: The study was approved by the Italian Medicines Agency (AIFA). The trial was conducted in accordance with the principles established in the Declaration of Helsinki and the International Conference on Harmonization guidelines for good clinical practice. All trial documents and procedures were approved by the appropriate ethics committees at each site, and written informed consent (or verbal witnessed consent) was obtained from all patients before initiation into the study.

Intravesical administration of combined hyaluronic acid and chondroitin sulfate can improve symptoms in patients with refractory bacillus Calmette-Guerin-induced chemical cystitis: Preliminary experience with one-year follow-up.

We investigated the efficacy of intravesical instillations of combined hyaluronic acid (HA) and chondroitin sulphate (CS) in patients with bacillus Calmette-Guérin (BCG)-induced chemical cystitis unresponsive to first-line therapies. We retrospectively reviewed the clinical records of patients with grade 2 BCG-induced chemical cystitis unresponsive to first line therapeutic options performed according to the International Bladder Cancer Group guidelines who underwent intravesical instillations of HA/CS. Bladder pain, urinary urgency, voiding volume and number of voids/24 hours recorded prior to treatment, at the end of the treatment, at six months and at one-year follow-up were recorded and analyzed. The records of 20 patients were identified. All patients underwent eight weekly instillations of HA/CS. Mean baseline visual analogue scale (VAS) scores ± Standard Deviation (SD) for urinary urgency and bladder pain were 7.8 ± 0.5 and 7.2 ± 1.0, respectively. Mean number of voids/24 hours ± SD was 15.4 ± 2.3 and mean urine volume per void ± SD was 85.8 ± 21.0 mL. At the end of the treatment, mean VAS scores ± SD for urgency and pain significantly decreased to 4.7 ± 1.1 and 4.2 ± 0.9, respectively (p < 0.05 in both cases). Mean number of voids/24 hours ± SD decreased to 9.6 ± 1.4 (p < 0.05) and mean urine volume per void ± SD significantly increased to 194.1 ± 59.5 mL (p < 0.05). At six months and one-year followup, all outcome measures remained stable. Bladder instillations of HA/CS provide significant and durable improvement of bladder pain, urinary urgency, urinary volume per void and urinary frequency in patients with refractory BCG-induced chemical cystitis.

Role of ozone Disc Nucleolysis in Herniated intervertebral Disc: The Indian experience

Aim: To study the role of ozone disc Nucleolysis in herniated intervertebral disc &#x0D; Materials: We retrospectively analysed consecutives patients undergoing ozone disc nucleolysis. There were Total of 5265 patients with 2740 males and 2525 females .their Age was ranging from 17yrs to 84 years. Patients weight was ranging from 36 to 138 kilograms. All the patients had failed conservative management for at least 3weeks. &#x0D; Methods: All the patients were clinically evaluated as per inclusion and exclusion criterions. Pre-treatment Visual Analogue scale (VAS)and Oswestry Disability Index (ODI).All the patients undergone Pre-treatments work up of MRI of the spine.256 patients were undergone Nerve physiological study(EMG,NCV and SSEP).All the procedures were carried out in Cathlab (Siemen's Artis zee) under local anaesthesia. In Lumbar region 3 cc of ozone and in cervical 1cc of ozone-oxygen mixture injected .In Lumbar region additionally 7cc of ozone –oxygen mixture along with local anaesthetic(Lidocaine) –corticosteroid(Hydrocortisone and triamcinolone) –rheological enzyme (hynidase) injected in epidural space. There were 4406 patients with Lumbar disc herniation and 861 patients with cervical disc herniation. Statistical Analysis was done by SAS online version 2 Results: Outcome was assessed by VAS score, Oswestry Disability Index and modified MacNab scale at 6 month, 12 months and 18 months The mean baseline VAS score was 9 which became 4.9 post ozone disc nucleolysis . Disability Index was 36.13 at baseline which improved to 9.86 post treatment. Success rate was 81% by Modified MacNab outcome scale. Results by all above mentioned the three methods were found to be statistically significant. Conclusion: Ozone disc nucleolysis is highly effective in the treatment of herniated intervertebral disc .It is safe, Durable and cost effective in our series. Our results were slightly better than the published literature. However randomised control trial is recommended to further substantiate our results.

Intravenous versus oral paracetamol for acute pain in adults in the emergency department setting: a prospective, double-blind, double-dummy, randomised controlled trial

ObjectiveTo determine if intravenous paracetamol was superior to oral paracetamol as an adjunct to opioids in the management of moderate to severe pain in the ED setting.MethodsA prospective, randomised, double-blind,...

Ablation of the basivertebral nerve for treatment of back pain: a clinical study

Background ContentLumbar axial back pain arising from degenerative disc disease continues to be a challenging clinical problem whether treated with nonsurgical management, local injection, or motion segment stabilization and fusion. PurposeThe purpose of this study was to determine the efficacy of intraosseous basivertebral nerve (BVN) ablation for the treatment of chronic lumbar back pain in a clinical setting. Study DesignPatients meeting predefined inclusion or exclusion criteria were enrolled in a study using radiofrequency energy to ablate the BVN within the vertebral bodies adjacent to the diagnosed level. Patients were evaluated at 6 weeks, and 3, 6, and 12 months postoperatively. Patient SampleSeventeen patients with chronic, greater than 6 months, low back pain unresponsive to at least 3 months of conservative care were enrolled. Sixteen patients were treated successfully following screening using magnetic resonance imaging finding of Modic type I or II changes and positive confirmatory discography to determine the affected levels. The treated population consisted of eight male and eight female patients; the mean age was 48 years (34–66 years). Outcome MeasuresSelf-reported outcome measures were collected prospectively at each follow-up interval. Measures included the Oswestry Disability Index (ODI), visual analogue scale score, and Medical Outcomes Trust 36-Item Short-Form Health Survey (SF-36). Materials and MethodsThis is an industry-sponsored study to evaluate the effectiveness of intraosseous nerves in the treatment of chronic back pain. Consented and enrolled patients underwent ablation of the BVN using radiofrequency energy (INTRACEPT System, Relievant Medsystems, Inc, Redwood City, CA, USA) guided in a transpedicular or extrapedicular approach. Preoperative planning determined targeted ablation zone and safety zones. ResultsMean baseline ODI of the treated cohort was 52±13, decreasing to a mean of 23±21 at 3 months follow-up (p<.001). The statistically significant improvement in ODI observed at 3 months was maintained through the 12-month follow-up. The mean baseline visual analogue scale score decreased from 61±22 to 45±35 at 3 months follow-up (p<.05), and the mean baseline physical component summary increased from 34.5±6.5 to 41.7±12.4 at 3 months follow-up (p=.03). ConclusionAblation of the BVN for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period.

Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!).

IntroductionAcute pain remains highly prevalent in the Emergency Department (ED) setting. This double-blind, randomized, placebo-controlled UK study investigated the efficacy and safety of low-dose methoxyflurane analgesia for the treatment of acute pain in the ED in the adult population of the STOP! trial.MethodsPatients presenting to the ED requiring analgesia for acute pain (pain score of 4–7 on the Numerical Rating Scale) due to minor trauma were randomized in a 1:1 ratio to receive methoxyflurane (up to 6 mL) or placebo (normal saline), both via a Penthrox® (Medical Developments International Limited, Scoresby, Australia) inhaler. Rescue medication (paracetamol/opioids) was available immediately upon request. Change from baseline in visual analog scale (VAS) pain intensity was the primary endpoint.Results300 adult and adolescent patients were randomized; data are presented for the adult subgroup (N = 204). Mean baseline VAS pain score was ~66 mm in both groups. The mean change from baseline to 5, 10, 15 and 20 min was greater for methoxyflurane (−20.7, −27.4, −33.3 and −34.8 mm, respectively) than placebo (−8.0, −11.1, −12.3 and −15.2 mm, respectively). The primary analysis showed a highly significant treatment effect overall across all four time points (−17.4 mm; 95% confidence interval: −22.3 to −12.5 mm; p < 0.0001). Median time to first pain relief was 5 min with methoxyflurane [versus 20 min with placebo; (hazard ratio: 2.32; 95% CI: 1.63, 3.30; p < 0.0001)]; 79.4% of methoxyflurane-treated patients experienced pain relief within 1–10 inhalations. 22.8% of placebo-treated patients requested rescue medication within 20 min compared with 2.0% of methoxyflurane-treated patients (p = 0.0003). Methoxyflurane treatment was rated ‘Excellent’, ‘Very Good’ or ‘Good’ by 77.6% of patients, 74.5% of physicians and 72.5% of nurses. Treatment-related adverse events (mostly dizziness/headache) were reported by 42.2% of patients receiving methoxyflurane and 14.9% of patients receiving placebo; none caused withdrawal and the majority were mild and transient.ConclusionThe results of this study support the evidence from previous trials that low-dose methoxyflurane administered via the Penthrox inhaler is a well-tolerated, efficacious and rapid-acting analgesic.FundingMedical Developments International (MDI) Limited and Mundipharma Research GmbH & Co.KG.Trial registrationClinicaltrials.gov identifier: NCT01420159, EudraCT number: 2011-000338-12.