VAS Reduction Research Articles

Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months

Rhizarthrosis is the most frequent form of osteoarthritis and is responsible for pain, disability and reduced functionality. The aim of the study is to investigate the clinical effects of shock wave treatment in patients suffering from arthritis of the first finger. A prospective clinical study was designed, in which 72 patients affected by rhizarthrosis were randomized to treatment with shock waves or exercises; in both groups an immobilization brace was used on the first finger. At recruitment and at 1, 3 and 6 months, patients received assessments of pain (VAS), functionality (FIHOA) and disability (DASH); furthermore, the perception of improvement was monitored during follow-ups (Roles and Maudsley Score). In both groups there was a significant improvement in all scores in the comparison between recruitment and 6 months. The perception of improvement was statistically better in the shock wave group than in the exercise group at 1, 3 and 6 months. The regression analysis showed that the reduction of VAS and DASH were statistically influenced by shock wave treatment (p < 0.001). Both therapies are effective in managing patients suffering from arthritis of the first finger, but the shock wave treatment could ensure greater persistence of improvements.

033. Outcomes of Embolization with Various Embolic Agents in Patients with Pelvic Congestion Syndrome: A Literature Review

Background: Pelvic congestion syndrome (PCS) is a condition that causes chronic pelvic pain in women of reproductive age.1 There are several management options, one of which is venous embolization using a variety of embolic agents. This literature review aims to explore various embolic agents and its effectiveness in treating PCS. Method: Literature search was performed at 4 different databases, resulting in 13 usable studies with total of 1153 subjects that were further analyzed and included in this literature review. Results: Different options for embolization summarized in this study include coiling, vascular plug, sclerosant agent, glue, and vinyl alcohol copolymer. Coiling is the option most used, with 9 studies mentioned its usage. In all the studies, positive outcomes were observed (reduction in VAS, clinical remission), but there are still few studies that compare the variety of embolic agents and their outcome. Conclusion: Embolization remains a viable option for PCS management, but further clinical trials are needed to compare different types of embolic agents and their outcomes.

Ultrasound-guided infiltration with hyaluronic acid compared with corticosteroid for the treatment of Morton's neuroma.

A local injection may be used as an early option in the treatment of Morton's neuroma, and can be performed using various medications. The aim of this study was to compare the effects of injections of hyaluronic acid compared with corticosteroid in the treatment of this condition. A total of 91 patients were assessed for this trial, of whom 45 were subsequently included and randomized into two groups. One patient was lost to follow-up, leaving 22 patients (24 feet) in each group. The patients in the hyaluronic acid group were treated with three ultrasound-guided injections (one per week) of hyaluronic acid (Osteonil Plus). Those in the corticosteroid group were treated with three ultrasound-guided injections (also one per week) of triamcinolone (Triancil). The patients were evaluated before treatment and at one, three, six, and 12 months after treatment. The primary outcome measure was the visual analogue scale for pain (VAS). Secondary outcome measures included the American Orthopaedic Foot and Ankle Society (AOFAS) score, and complications. Both groups showed significant improvement in VAS and AOFAS scores (p < 0.05) after 12 months. The corticosteroid group had a significantly greater reduction in VAS and increase in AOFAS scores compared with the hyaluronic acid group, at one, three, and six months, but with no significant difference at 12 months. There were no complications in the hyaluronic acid group. There were minor local complications in six patients (six feet) (25.0%) in the corticosteroid group, all with discolouration of the skin at the site of the injection. These minor complications might have been due to the three weekly injections of a relatively high dose of corticosteroid. No patient subsequently underwent excision of the neuroma. An ultrasound-guided corticosteroid injection showed statistically significantly better functional and pain outcomes than an ultrasound-guided injection of hyaluronic acid for the treatment of a Morton's neuroma at many timepoints. Thus, a corticosteroid injection should be regarded as a primary option in the treatment of these patients, and the only indication for an injection of hyaluronic acid might be in patients in whom corticosteroid is contraindicated.

Does Cannabis-based Medicine Improve Pain and Sleep Quality in Patients With Traumatic Brachial Plexus Injuries? A Triple-blind, Crossover, Randomized Controlled Trial.

After traumatic brachial plexus injuries, despite treatment with appropriate medications, some patients experience uncontrollable pain, which can be devastating. Cannabis-based medicine is considered to have pain-relieving benefits in this situation, but the evidence is limited. Is cannabis-based medicine effective compared with the placebo in (1) reducing pain (measured by the VAS for pain) and neuropathic pain (measured by the DN4 questionnaire), and (2) improving sleep quality (measured by the VAS for sleep quality) in patients with traumatic brachial plexus injury? This prospective, triple-blinded (the researcher administering the substance, the patients, and the evaluator were all blinded to the substance used), two-period crossover, placebo-controlled, randomized controlled trial was conducted at a single center. Between January 2020 and January 2022, we treated 147 patients for neuropathic pain related to a traumatic brachial plexus injury. Our inclusion criteria were age between 20 and 60 years and moderate-to-severe pain (VAS for pain equal to or greater than 4 of 10 for more than 6 months), even with the use of appropriate medications. Based on these criteria, 20% (30) of patients were eligible. They were randomly allocated to receive either cannabis-based medicine followed by the placebo or vice versa. Fifteen patients received cannabis-based medicine first, and 15 patients received the placebo first. The groups did not differ at baseline in terms of demographic parameters. Participants received both the cannabis-based medicine and the placebo; they started with 10 days of the initial intervention, followed by a 14-day washout period, and then a 10-day period with the second intervention. The dosage regimen adhered strictly to the protocol. The outcomes were the (1) VAS for pain, which ranges from 0 to 10 and where 0 represents no pain and 10 signifies the worst pain; (2) the DN4 questionnaire which ranges from 1 to 10 and where a score of 4 or higher indicates a positive result for neuropathic pain; and (3) VAS for sleep quality, from 0 (worst) to 10 (best). The minimum clinically important difference of VAS for pain was defined as a 2-point improvement. After enrollment, 7% (2 of 30) of patients (one patient received the cannabis-based medicine first and another received the placebo first) were lost before the minimum study follow-up, leaving 93% (28 of 30) for analysis. With 28 patients in each group, the study was powered a priori at 90% to detect a clinically important difference of 2 points in the VAS for pain. No carryover or period effects were observed in the study. Four patients experienced mild dizziness during the cannabis-based medicine period but were able to continue the intervention. When comparing the use of cannabis-based medicine alongside pain control medications with the combination of placebo and pain control medications, the reduction in pain VAS from the preintervention resulted in a mean difference of 1 (99% CI -0.03 to 2.1; p = 0.01). Neuropathic pain was reported by 75% (21 of 28) of patients in both interventions (OR 1 [99% CI 0.07 to 14.1]; p > 0.99). The VAS for sleep quality favored cannabis-based medicine with a mean difference of 1.5 (99% CI 0.7 to 2.4; p < 0.001). Our study findings indicate that cannabis-based medicine did not improve pain by a clinically important margin. Consequently, our study advises against the addition of cannabis-based medicine to the standard medication treatment for pain in patients with traumatic brachial plexus injury. Level 1, therapeutic study.

Add-on Vitamin E in Improving Treatment Outcomes in Diabetic Peripheral Neuropathy: A Prospective Interventional Study

Background: Neuropathy is one of the most common long-standing complications of diabetes, affecting over 50% of the diabetic individuals. Managing DPN and its complications involves comprehensive care and a multidisciplinary approach. Besides pharmacological treatments, botanicals and dietary supplements that have also been found to improve symptoms of DPN without affecting glucose control. The possible role of vitamin E in the management of DPN have been postulated in various studies. The present study thus aimed to prospectively assess whether add-on treatment with vitamin E can improve treatment outcomes in diabetic peripheral neuropathy.Methods: The study included newly diagnosed patients with diabetic peripheral neuropathy for a period of initial two months. Patients were randomly allocated to either standard treatment Group (Group A) or the interventionGroup (Group B). As a part of intervention, patients received vitamin E 400mg once daily in addition to thestandard of care. Efficacy Parameters measured at baseline, 6 months and 12 months included changes in visual analog scoring, mean pain score, brief pain inventory and patient’s global impression of change. Treatment safety, quality of life and treatment adherence was assessed. Data was statistically analysed.Result: The study included a total of 100 patients, 50 patients in each Group. Significantly higher decrease of glycaemic measures was noted for Group B compared to Group A in terms of PPPG and serum creatinine, however, there was comparable change in HbA1c and FPG for both Groups. There was comparable significant reduction in mean VAS scoring at 6 and 12 months for Group B. Considering all the efficacy measures, there was highest reduction for the pain interference in the intervention arm (Group B), in comparison to Group A. (p&lt;0.001). Quality of life measures and mean adherence scoring significantly increased for treatment group B as compared to A at both 6 months and 12 months of study assessments. No major safety concerns were reported during the study period.Conclusion: Our study noted that addition of vitamin E as an added supplementation to the standard of careshowed benefits in terms of patient reported reduced pain interference and pain perception, which also significantly improved overall quality of life in these patients.

Successful treatment of solar lentigines by topical application of stabilized cysteamine: A vehicle-controlled, double-blind randomized study.

Solar lentigines are common hyperpigmented lesions typically appearing after 50 years of age and associated with negative psychological effects in affected individuals. Topical depigmenting products, such as hydroquinone and even the Kligman's formula, are usually ineffective for treating lentigines. Stabilized cysteamine has been recently shown to be as effective as the modified Kligman's formula for treating melasma. In this study, we evaluated the therapeutic effect of a stabilized cysteamine on solar lentigines. A vehicle-controlled, double-blind, and randomized study was performed on 30 patients with solar lentigines. Stabilized cysteamine or vehicle control creams were applied on solar lentigines on the dorsum of the hands daily for 12 weeks. Clinical measurements with colorimetry and visual analog scale were performed at baseline, 4, 8, and 12 weeks. Statistically significant results were obtained in the cysteamine group versus the vehicle control group. Stabilized cysteamine provided a 40% reduction in colorimetric values (p < 0.002) versus a 2% reduction in the vehicle group (p < 0.405). Cysteamine also provided a 40% reduction in VAS (p < 0.001) versus a 2% reduction in the vehicle group (p < 0.245). Significant improvement of solar lentigines was observed after 12 weeks of application of stabilized cysteamine by all evaluation methods. Stabilized cysteamine represents a highly effective topical treatment for solar lentigines and can be considered as one of the first topical therapies effective on this hyperpigmentary disorder.

Topical applications of heterologous platelet rich plasma (PRP) for refractory gingival lesions in autoimmune blistering diseases.

Recalcitrant gingival erosions, blisters and desquamative gingivitis are common features in oral autoimmune blistering diseases (AIBD). First line treatments include high-dosage corticosteroids and other immunosuppressive drugs, with several side effects and elevated number of recurrences. Autologous platelet-rich plasma (PRP) has been recently introduced as an alternative treatment and its use seems to be promising and safe. In this study we describe the use of topical application of heterologous PRP in nine patients affected by mucous membrane pemphigoid, with gingival lesions refractory to previous treatments. Topical applications of PRP were performed once a week for 2 months and the endpoint for clinical evaluation was set 3 months after the last session. Oral disease severity score (ODSS) and VAS scores for pain measurement were recorded before and after treatment. The procedure was painless, well accepted, and free from adverse reactions. All patients (100%) reported a reduction in VAS whereas reduction in ODSS was observed in 89% of patients. Within the limits of the study, topical heterologous PRP is a safe and promising procedure to be studied in future controlled randomized trials as adjuvant treatment for refractory gingival lesions in patients with AIBDs.

Shoulder pain management strategies and early functional outcome after arthroscopic rotator cuff tear repair. A randomized controlled study

BackgroundThe management of acute postoperative pain after rotator cuff surgery can be challenging. To our knowledge, there are no data available in the literature correlating satisfactory pain control with improvement in terms of function. The purposes of the present study were to evaluate: 1) pain pattern after arthroscopic rotator cuff repair in patients operated with two different techniques (transosseous vs transosseous equivalent); 2) safety/efficacy of three different pharmacological pain control strategies; 3) possible relationship between a correct shoulder pain management protocol in the early post-operative period and patients’ functional improvement. Methods114 patients underwent rotator cuff tear repair, either with a Transosseus or a Transosseus equivalent technique. 62 (54%) were male and 52 (46%) were female. The average age was 59 ± 9 years. They were randomly assigned into three different pain management protocols: Paracetamol as needed (max 3 tablets/day) for 1 week (Protocol A), Paracetamol + Codein 1 tablet three times per day for 7 days (Protocol B), or Paracetamol + Ibuprofen 1 tablet two times per day for 7 days (Protocol C). Immediate passive mobilization of the operated shoulder was allowed. VAS and Passive Flexion values were recorded at 7 (T1), 15 (T2) and 30 (T3) days post-surgery. DASH values were recorded at 90 days post-surgery. All patients were asked to register any kind of signs/symptoms that may appear during drug assumption according to each pain management protocols. ResultsAll the pain management protocols administered were well tolerated by all the study population, and no adverse signs/symptoms were highlighted during drug assumption.Pain pattern: in both surgical techniques, patients within Protocol A were associated with worst results in terms of mean VAS at each time point examined when compared to Protocol B and C (p < 0,05). In patients within Protocol A, no statistically significant differences were found at each point time examined comparing the two surgical techniques, with the exception of T2, where the TO was associated with an higher VAS value than TOE (p < 0.05). No differences were highlighted in Protocol B and C when comparing the values between two surgical techniques.ROM: in both surgical techniques, patients within Protocol A were associated with worst results in terms of mean PROM at each time point examined when compared to Protocol B and C (p < 0,05). In the TO group, patients within Protocol B had better PROM values at T1 (p < 0,05) and T2 (p < 0,05) compared to Protocol C, but no differences were highlighted at T3. In the TOE group, no statistically significant differences were found between patients within Protocol B and C at each time point examined.DASH: In the TO group, no statistically significant differences were found regarding the DASH values comparing Protocol B vs Protocol C, but they were highlighted comparing the values between Protocol A and Protocol B (p < 0,05), and between Protocol A and Protocol C (p < 0,05). Similar results were recorded in the TOE group. ConclusionPost-operative pain is influenced by the surgical technique used being transosseous more painful in the first 15 days after surgery. Oral anti-inflammatory drugs are a feasible strategy to appropriately control post-operative pain. An association between Paracetamol and either Codein or Ibuprofen can lead to better outcomes in terms of VAS reduction and early recovery of passive ROM.

Comparison between adenosine and magnesium sulfate as an adjuvant for ultrasound-guided rectus sheath block. A prospective randomized controlled study

ABSTRACT Background Rectus sheath block (RSB) is an effective nerve block. This study aimed to compare adenosine and magnesium sulfate as an adjuvant for ultrasound-guided RSB (UG-RSB). Methods This prospective controlled randomized trial was performed on 96 adult patients (ASA I and II) undergoing umbilical or epigastric hernia repair. The patients were assigned randomly to three equal groups and got bilateral UG-RSB. Adenosine group: using 20 ml bupivacaine hydrochloride 0.25% + 12 mg of adenosine (4 ml) +1 ml saline 0.9%. Magnesium group: using 20 ml bupivacaine hydrochloride 0.25% + 500 mg of magnesium sulfate (5 ml). Control group: using 20 ml bupivacaine hydrochloride 0.25% + 5 ml of saline 0.9%. Registration No.: 6/2018ANET17 Results A significant postoperative reduction of VAS up to 18 h was detected in the magnesium sulfate group and up to 12 h was detected in the adenosine group. A statistically significant prolongation of time to the first analgesia in magnesium and adenosine groups than control groups (483.44 ± 48.03 & 415.28 ± 29.81 than 325.31 ± 50.29, respectively), as well as the mean postoperative morphine consumption was 5.94 ± 1.61, 8.03 ± 1.0 and 16.69 ± 2.49 among magnesium, adenosine, and control groups, respectively. The postoperative complications were statistically significantly higher in the control group. Conclusion This study validates the effectiveness of adenosine versus magnesium sulfate as good adjuvants for improving the quality and duration of UG-RSB and reduction of postoperative narcotic requirements. However, the duration was relatively longer with magnesium sulfate.

The application of microwaves in axillary hyperhidrosis: Curative effect observation of a pathological examination over 1 year.

In Asia, axillary hyperhidrosis is a frequent problem for many people, and the consequent excessive sweating can seriously affect many aspects of daily life and even lead to mental disorders. Microwave therapy is a new, non-invasive treatment method for axillary hyperhidrosis, whose energy and long-term effectiveness still needs to be clinically validated. The aim of this study was to evaluate the clinical efficacy, safety, histological changes, and psychological status of microwave devices in the treatment of axillary hyperhidrosis and osmidrosis. We conducted a prospective self-controlled study in a top-tier Chinese hospital. After a 5/5 energy treatment session, a skin biopsy was taken to observe histological changes both before and after treatment. An iodine starch test was used to determine the sweating range. We evaluated symptoms of improved efficacy using the Hyperhidrosis Disease Severity Scale (HDSS) and assessed changes in life status with the DLQI. In the case of concurrent underarm odor, odor-5, VAS, and Young-Jin Park grading were used to assess odor relief. The effect of odor on psychology was assessed by using a psychological status symptom checklist (scl-90). The study period was 1 year. We observed 20 patients in this study. Of those, 90% met the primary treatment endpoint of a decrease in axillary hyperhidrosis symptomatology to below grade 2 on the HDSS score (p < 0.001). Furthermore, 75% of patients achieved a treatment endpoint of at least 50% reduction in VAS (p < 0.001). 70% of patients achieved a treatment endpoint of at least 50% reduction in odor-5 (p < 0.001). The iodine starch test showed that the region decreased 99% from the baseline to 12 months after follow-up had ended (p < 0.001). Eight patients volunteered to undergo histological examination; their average light density of immunohistochemistry decreased from 1.04 (0.4-2.11) to 0.07 (0.04-0.46; p < 0.05). The immunohistochemical positive number for sweat glands was initially 104 (59.75-132.5) but was 41.5 (29.75-62) after the procedure. None of the patients experienced any serious adverse reactions. The treatment demonstrated high effectiveness, safety, and short-lived adverse reactions.

A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study

ObjectivesThe aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP). Materials and MethodsTwenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated. ResultsMean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was −51.7 mm (95% CI, −60.7 to −42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures. ConclusionsThis novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems. Clinical Trial RegistrationThis study is registered on anzctr.org.au with identifier ACTRN12618000647235.

Management of Medication-Related Osteonecrosis of the Jaw with Photobiomodulation and Minimal Surgical Intervention

Medication-related osteonecrosis of the jaw (MRONJ) is a relatively common pathology occurring in around 5% of patients taking bisphosphate and other antiresorptive or anti-angiogenic medications. Despite the efforts, as of today there is still no consensus on its management. In this case report, the successful management of stage II MRONJ was performed for an eighty-three-year-old female patient suffering from pain and alteration in her normal oral functions (swallowing and phonation). The treatment consisted of three sessions of photobiomodulation therapy (PBM), followed by minimal surgical intervention and three other sessions of PBM. PBM was applied on the sites of osteonecrosis with the follow parameters: 4 J/cm2; a power of 50 mW; 8 mm applicator diameter; a continuous contact mode. Irradiation was performed on three points, including the vestibular, occlusal and lingual parts of each of the bone exposure areas. Each point was irradiated for 40 s, and, in total, nine points were made per session, and nine sessions were conducted. To assess the pain, a visual analogue scale was used in which zero represented no pain at all and ten represented the greatest pain. At the first session and before any intervention, the patient stated that her pain was 8 out of 10. At the end of the treatment, a significant reduction in VAS was noted (2/10) and, clinically, a healing of the soft tissue in the previously exposed bone was observed. This case report suggests that the combination of PBM with surgical intervention is promising in the management of MRONJ.

P099 Attention-based Virtual Reality - A Safe, Acceptable and Potentially Highly Effective Treatment for Fibromyalgia Syndrome: Findings from The VIPA Study

Abstract Background/Aims Chronic pain is highly prevalent and a leading cause of disability worldwide with a crippling socioeconomic cost. Current non-pharmacological management of conditions including Fibromyalgia Syndrome (FMS) are labour intensive to implement and not widely available. There is an urgent need to develop accessible, innovative treatments for pain cohorts. Virtual reality (VR) is a modern technology that immerses users within a three-dimensional, interactive virtual environment delivered through a head-mounted display. VR is widely used for acute pain, following multiple randomised controlled trials showing efficacy. Despite growing numbers of feasibility studies and a handful of larger clinical trials, robust evidence within chronic pain cohorts including FMS is still limited. Through the VIPA Study, we investigated the impact of different VR characteristics on acceptability and pain using multiple feasibility studies in patients with FMS. Methods Patients with FMS were recruited through outpatient clinics at the Norfolk and Norwich University Hospital. We investigated four VR systems representing the spectrum of commercially available technologies. Participants used each system in a random order for five minutes. The interactive VR program experienced with each headset was co-developed alongside industry partners specifically for patients with chronic pain. Baseline questionnaires included the McGill pain questionnaire short form (MPQ-SF; total score: 0-45), pain visual analogue scale (VAS; 0-10) and Revised Fibromyalgia Impact Questionnaire (FIQR; total score: 0-100). MPQ-SF and VAS data were also collected approximately 15 minutes after use of the fourth headset (post-intervention). Questionnaires collected acceptability data using 7-point Likert scale rating questions (1=strongly disagree to 7=strongly agree). The VR sickness questionnaire (VRSQ) gained side-effect data (total severity score: 0-100). Results 26 participants with FMS were included (mean (SD) age 48 ±14yrs, 88% female). Disease severity ranged from moderate to extreme (mean FIQR 65 ±16). Following use of all headsets, a 40% reduction in mean MPQ-SF total scores from baseline were reported (baseline 24 ±9, post-intervention 15 ±9, p = &amp;lt;0.001). A 24% reduction in mean pain VAS was observed (baseline 5.5 ±1.9, post-intervention 4.0 ±1.9, p = &amp;lt;0.001) with one participant reporting an 80% reduction (change in VAS: 5.9). Participants indicated high levels of acceptability across VR systems when asked about comfort, quality, usability and immersion (mean total headset score ranged from 77-97 out of 105). Side effects were infrequent and mild (mean total VRSQ score across devices: 17 ±12). 100% agreed they would be open to using VR regularly at home for pain management (mean rating 6.5 ±0.6). Conclusion Patients with FMS can experience large reductions in pain following VR, find the technology acceptable with limited side effects, and are open to home use for pain management. VR has enormous potential as an accessible, home-based treatment for chronic pain. VIPA provides strong justification for future RCTs investigating efficacy and dose-response. Disclosure J. Tsigarides: Grants/research support; J.T. has received a small amount of funding from Orbital Global Ltd to support research equipment purchase for The VIPA Study. V. Grove: None. N. Shenker: None. J. Dainty: None. J. Chipping: None. S. Miles: None. S. Sami: None. A. MacGregor: None.

The Choice of Spinal Cord Stimulation Versus Targeted Drug Delivery in the Management of Chronic Pain: Validation of an Outcomes Predictive Formula

ObjectiveIn 2020, Mekhail et al published a formula that predicted the likelihood of a successful outcome for those who undergo spinal cord stimulation (SCS) for long-term pain management, based on retrospectively collected clinical and demographic data from one major medical center. The aim of this study is to validate such a predictive formula, prospectively, in a cohort of patients from multiple medical practices that are more representative of real-life clinical practice. Materials and MethodsFor the study, 939 patients who underwent successful SCS or targeted drug delivery (TDD) trials at multiple independent medical centers in the USA were enrolled into the Medtronic product surveillance registry data base before they underwent SCS or TDD device implantation, from 2018 to 2020. The registry data were collected prospectively but not specifically for this study. The data examined included demographic information, pain diagnosis, pain scores (visual analog scale [VAS]), Oswestry Disability Index scores, and quality-of-life scores at baseline and six months after implant. Because our goal is to validate the previously published predictive formula, in addition to the outcomes data previously mentioned, we collected the variables necessary for such a task: sex, age, depression, the presence of neuropathic pain, spine-related pain diagnosis, and persistent spinal pain syndrome “post laminectomy syndrome.” Spine-related pain diagnosis included subjects with chronic spine pain who never had back surgery and whose pain was not radicular nor neuropathic. ResultsOf 619 patients with SCS, 138 (22%) achieved ≥ 50% reductions of the baseline VAS at six months. The logistic model predicts SCS success with an area under the receiver operating characteristic curve (AUC) of 80% in the current validation data set. Of 320 patients with TDD, 147 (46%) achieved ≥ 50% reduction of the baseline VAS at six months. The logistic model predicts TDD success with an AUC of 78% in the current validation data set. ConclusionThe study provides real life validation of the previously published predictive formula(4).

The Effectiveness of Various Types of Electrical Stimulation of the Spinal Cord for Chronic Pain in Patients with Postherpetic Neuralgia: A Literature Review.

Postherpetic neuralgia (PHN) is a severe condition that remains a challenge to treat. Spinal cord stimulation (SCS) is used in cases of insufficient efficacy of conservative treatment. However, in contrast to many other neuropathic pain syndromes, there is a huge problem in reaching long-term stable pain relief in patients with PHN using conventional tonic SCS. The objective of this article was to present a review of the current management strategies of PHN, their efficacy, and safety. We searched for articles containing the keywords "spinal cord stimulation AND postherpetic neuralgia," "high-frequency stimulation AND postherpetic neuralgia," "burst stimulation AND postherpetic neuralgia" and "dorsal root ganglion stimulation AND postherpetic neuralgia" in Pubmed, Web of Science, and Scopus databases. The search was limited to human studies published in the English language. There were no publication period limitations. Bibliographies and references of selected publications on neurostimulation for PHN were further manually screened. The full text of each article was studied once the abstract was analyzed by the searching reviewer and found appropriate. The initial search yielded 115 articles. Initial screening based on abstract and title allowed us to exclude 29 articles (letters, editorials, and conference abstracts). The full-text analysis allowed us to exclude another 74 articles (fundamental research articles, research utilizing animal subjects, and systemic and nonsystemic reviews) and results of PHN treatment presented with other conditions, leaving 12 articles for the final bibliography. 12 articles reporting on the treatment of 134 patients with PHN were analyzed, with a disproportionally large amount of traditional SCS treatment than that to alternative SCS: DRGS (13 patients), burst SCS (1 patient), and high-frequency SCS (2 patients). Long-term pain relief was achieved in 91 patients (67.9%). The mean VAS score improvement was 61.4% with a mean follow-up time of 12.85 months. Although the number of patients in alternative SCS studies was very limited, almost all of them showed good responses to therapy with more than 50% VAS improvement and reduction of analgesic dosage. The article contains a review analysis of 12 articles concerning the current methods of treatment for postherpetic neuralgia including conservative treatment, spinal cord stimulation, and novel neuromodulation strategies. Available information on the pathophysiology of PHN and the effect or stimulation on its course, together with a number of technical nuances concerning various types of neurostimulation are also elucidated in this article. A number of alternative invasive treatments of PHN are also discussed. Spinal cord stimulation is an established treatment option for patients with pharmacologically resistant PHN. High-frequency stimulation, burst stimulation, and dorsal root ganglion stimulation are promising options in the management of PHN due to the absence of paresthesias which can be painful for patients with PHN. But more research is still required to recommend the widespread use of these new methods.

Surgical management of isthmic spondylolisthesis: A comparative study of postoperative outcomes between ALIF and TLIF

IntroductionCircumferential fusion by the anterior (ALIF) or transforaminal (TLIF) approach combined with posterior instrumentation is currently used for the surgical treatment of low-grade isthmic spondylolisthesis. But few studies have compared the clinical and radiological outcomes of various interbody fusion techniques. The objective of this study was to compare the clinical and radiological results at 2 years postoperative of two fusion techniques–TLIF versus ALIF plus posterior instrumentation–for low-grade isthmic spondylolisthesis in adults. Materials and methodsThis was an observational multicenter study done at nine French healthcare facilities specialized in spine surgery. The inclusion criteria were minimum age of 18 years, grade 1–3 isthmic spondylolisthesis, ALIF+posterior fixation (ALIF+PS) or TLIF, minimum follow-up of 2 years. Clinical and radiological evaluations were done preoperatively and at 2 years of follow-up. A lumbar CT scan was done at 1 year postoperative to evaluate fusion. ResultsThe cohort consisted of 89 patients (50 women, 39 men) with a mean age of 47.7±12.3 (18–79) years. The patients in the ALIF groups (n=71) had a significantly longer hospital stay than those in the TLIF group (n=18): 5.7 days versus 4.6 days (p=.04). However, their medical leave from work was significantly shorter: 31.0 weeks versus 40.7 (p=.003). Lumbar pain VAS diminished faster in the ALIF groups, with a significantly larger drop than the TLIF group in the first 3 months postoperative. Only the increase in lumbar disc lordosis was larger in the ALIF group: 11.7°±12.0° versus 6.0°±11.7° (p=.036). There was a significant correlation between the increase in global lordosis and reduction in lumbar VAS at 2 years postoperative (ρ=−0.3295; p=.021). ConclusionALIF+PS provides a faster relief of postoperative low back pain than TLIF but there are no significant clinical differences between techniques at 2 years of follow-up. Despite better restoration of disc lordosis in the ALIF+PS group, there was no difference in the restoration of global lordosis. Level of evidenceIII; multicenter comparative study.

Incidence of Complications in Early vs. Late Laparoscopic Cholecystectomy after Acute Cholecystitis

Background: The majority of digestive tract illnesses are caused by biliary ailments. Cholelithiasis is one of them,that produces generalized illness, necessitating surgical intervention for complete recovery. Aims: The goal ofthis study was to compare the outcomes of early (within one week) and delayed (after six weeks) laparoscopiccholecystectomy for acute cholecystitis.Patients and Methods: This study was took place from November 2019 to July 2021, at the General Surgerydepartment, Beni-Suef University hospitals, with 54 cases diagnosed with acute cholecystitis during the studyperiod were included. Patients were randomized using the closed envelope method.Results: Operative time showed significant prolongation in the delayed group (76.12 vs. 37.98 minutes in the earlygroup – p &lt; 0.001).Early intervention was associated with a significant reduction in post-operative pain measuredby VAS (3 vs. 4 in the other group – p = 0.015). Patient satisfaction was significantly improved in the early groupcompared to the late group (p &lt; 0.001).Conclusion: This study found that laparoscopic cholecystectomy at early stage is a safe and feasible therapeuticoption for cholecystitis. It’s linked to lower VAS scores, shorter operative times, and lower complication rates. It’snot statistically significant, but related to higher patient satisfaction.

Examining the Effects of Mirror Therapy on Psychological Readiness and Perception of Pain in ACL-Injured Female Football Players.

Virtual reality-guided imagery (VRGI) and mirror therapy (MT) have been used in isolation to treat patients suffering from different injuries. However, no attempts have been made to understand the effects of combined VRGI and MT added to conventional physical therapy, and no information exists regarding perceptual responses to these rehabilitation strategies in female football players. Thus, this study aimed to examine the effect of MT added to conventional rehabilitation on psychological readiness and perception of pain in ACL-injured female football players. Thirty ACL-injured female football players competing in the 2nd and 3rd Italian tier who underwent an ACL rehabilitation program from the same clinic participated in this study. Players were randomly distributed in an MT group (n = 15) and a CON group (n = 15). All participants reported their perception of pain on a VAS before and after the interventions and their psychological readiness to return to sport after ACL injury and reconstruction surgery on the ACL-RSI scale after the intervention. An independent-sample t-test was performed to assess between-group differences in post-intervention ACL-RSI, and a further independent-sample t-test to assume non-significant differences between VAS values before the intervention. A two-way repeated-measures analysis of variance was used to test the null hypothesis of no different change in VAS over time between groups. After the intervention, the MT group perceived largely greater psychological readiness (p &lt; 0.01). MT and CON groups experienced a large reduction in VAS after the intervention (p &lt; 0.001). However, a small time × group interaction was observed (p = 0.023). MT reported a greater perception of the psychological readiness of the soccer players and a lower perception of pain than those who performed conventional therapy.

Effect of Perineural Dextrose Injection on Myofascial Pain Syndrome

Background: Myofascial pain syndrome (MFPS) is defined as the motor, sensory, and autonomic signs resulting from trigger points (TrPs). Objectives: To assess the effectiveness of the perineural injection in patients with MFPS. Materials and methods: The study was conducted at AL Ramadi Teaching Hospital, Department of Rheumatology, Ramadi City, Iraq. The study period was from June 2019 to January 2021. A retrospective review of 100 patients with prospectively collected clinical and radiologic data was performed to evaluate the effectiveness of perineural injection on MFPS. A 3 ml of 5% dextrose solution was managed sub-cutaneous straight at the labeled chronic constrictive injury and tender spots rounding the knee. The VAS and WOMAC were calculated for each participant at the time of the presentation and 1, 3, and 6 months following treatment. Results: The mean age of the patients was 60.93 ± 6.17 years (25-70 years). Three-quarters (75/100) of the cases were female. Seventy subjects were from the age group ≥ 40 years, while the remaining 30 cases were from the age group < 40 years. Fifty-five cases were with right-sided involvement. Successful results were achieved in 90% of the participants. There were no statistically significant differences between the effective and not effective groups regarding the age, gender, and the involved side (P-value > 0.05). There was a reduction in the mean VAS (8.47 ± 0.77) of pain and WOMAC (78.99 ± 5.69) score at the time of presentation to 1.87 ± 1.32 for the VAS and 17.84 ± 4.66 WOMAC at 6-months post-injection period. No complications were reported in all patients apart from mild pain at the injection site. Conclusion: Perineural dextrose injection was successful in 90% of the patients with MFPS. This modality results in a sharp reduction of both VAS and WOMAC scores from the time of the presentation to 6-months post-treatment. We recommend using this modality because it is easy, effective, and safe.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis. This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion. Patients are followed with reporting at 3months, and 12months for primary endpoint analysis of efficacy and safety based on improved composite endpoints relative to baseline, with success defined as greater than 20mm back pain reduction in Visual Analog Scale 100mm (VAS) while standing or walking, greater than 20mmleg pain reduction in VAS while standing or walking, Zurich Claudication Questionnaire (ZCQ) improvement of 0.5 or greater in two or three domains, Oswestry Disability Index (ODI) improvement of a least 10points and no reoperations or revisions at the index level(s). Secondary endpoints included a multidimensional assessment in the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 and Patient Global Impression of Change (PGIC). In this interim 3-month analysis, 82% of patients reported they were improved from the procedure, while 65% of patients demonstrated clinical meaningful improvement in their pain and function, as defined by the VAS, ODI, and ZCQ. There was only one adverse event and no complications were identified at last clinic research follow-up visit. This interim analysis of the first 20% of the enrolled patients out to 3months was to determine safety of the procedure and report on adverse events, acknowledging the heterogeneity of surgical specialty. Further follow-up and greater numbers are needed as the study is ongoing. ClinicalTrials.gov identifier, NCT05504499.