Analogue Scale Pain Intensity Research Articles

Frequency of Neck Pain and Associated Disability in Medical Students

Background: Musculoskeletal disorders, particularly neck pain, have been increasingly documented among medical students due to their rigorous academic and clinical training demands. The impact of neck pain can lead to significant disability, affecting academic performance and quality of life. Prior studies have demonstrated varying prevalence across different geographies, indicating a need for further localized research. Objective: This study aimed to assess the prevalence of neck pain and its associated disability using the neck disability index among students of Akhtar Saeed Medical College and to compare these findings with global data. Methods: A cross-sectional descriptive study design was employed, involving 150 students from various medical programs. Data collection was conducted via a structured questionnaire including the Neck Pain Disability Index and the Visual Analog Scale for pain intensity. Ethical approval was obtained in line with the Helsinki Declaration. The sample size was determined statistically, and the collected data were analyzed using SPSS version 24.0. Statistical tests including independent t-tests and Chi-square tests were utilized to discern the significance of associations, with a p-value of less than 0.05 considered statistically significant. Results: Participants had an average age of 22.74±2.04 years, with a gender distribution of 58.7% female and 41.3% male. The mean score for neck pain disability was higher in females (21.33±6.45) compared to males (20.76±5.11), albeit non-significantly (p=0.562). The prevalence of neck pain in our sample (58.7%) was higher than in similar cohorts from Brazil (8.23%), Thailand (22.3%), and China (33.8%), yet comparable to Pakistan (44.8%), Australia (52.8%), and Central Saudi Arabia (54%). Approximately 22.7% of students reported neck pain that interfered with their normal activities. Conclusion: Neck pain was found to be prevalent among the medical student population, with a higher incidence in females. The study underscores the association between neck pain and disability, suggesting the need for preventive measures and interventions within the medical academic setting.

Efficacy of local metronidazole with glyceryl trinitrate versus topical glyceryl trinitrate alone in the treatment of acute anal fissure: a randomized clinical trial

Introduction Anal fissure is one of the most common diseases of the anorectal region that is frequently encountered in surgical practice, equally affects both women and men. Acute anal fissures last shorter than 6 weeks. The American Society of Colon and Rectal Surgeons favors conservative management of anal fissure as the first line of treatment. A rectal ointment containing 0.2% glyceryl triturate (GTN) can be recommended to promote the healing of anal fissures and decreasing sphincter spasm. Metronidazole is a 5-nitroimidazole derivative antibiotic with a cytotoxic bactericidal effect particularly on anaerobic bacteria. The purpose of the present study was to investigate whether local metronidazole antibiotic cream is effective and safe to use in reducing the symptoms and improving the healing process of acute anal fissure. Patients and methods This study was performed in Mansoura University Hospital, surgery outpatient clinic from the period of July 2022 till July 2023. This study was a single-blinded, randomized controlled trial. Total 100 patients were included in this study and randomly divided into two groups, 50 patients in each group. First group (group 1) treated by combination of local metronidazole 10% with 0.2% GTN while the second group treated only with GTN. Results Anal pain were present in both group in all patients with acute anal fissure while constipation were 88% in group 1 and 76% group 2. To lesser extent itching, bleeding, and diarrhea were presented in both group. Visual analog scale for pain intensity were equal in both groups at the time of first clinical examination. After 1 week and 1 month of treatment there were statistically significant difference between both groups thus the visual analog scale were lower in group 1 than group 2 (0.001 and <0.001, respectively). Healing of acute anal fissure was assessed clinically at variable interval for all patients there is statistically significant difference between both group (0.004) as regard healing, first group showed earlier and faster healing and fewer number of nonhealing of the fissure at the end of follow up. Conclusion Adding local metronidazole 10% to the classic GTN treatment will improve the symptoms of acute anal fissure specially pain and discomfort and markedly accelerate healing process.

Effectiveness and safety of Xuefu Zhuyu oral liquid on -stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea: rationale and design of a master protocol.

We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on -stagnation and blood-stasis pattern (QBP). Three randomized controlled trials (RCTs) and real-world observational studies. Based on three registry cohorts of stable angina, tension-type headache and primary dysmenorrhea, patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu (, XFZY) oral liquid or a placebo, while patients with non-QBP will be enrolled in the observational studies and experience follow-up. 1414 patients (RCTs: 574; observational studies: 840) will be recruited at seven centers in China over a 3-year period. The primary outcome is the visual analog scale of pain intensity. Adverse events will also be reported. The analysis will be undertaken separately in each sub-study, and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid. This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.

Factors promoting improvements in symptoms and health in women with fibromyalgia and chronic widespread pain: a qualitative interview study

Purpose To describe experiences of improvement among women with chronic widespread pain (CWP). Materials and methods Recruitment was made from a cohort of women with CWP who participated in a 10- to 12-year follow-up study in 2016. The inclusion criterion was an improvement of at least 30% on a visual analog scale of pain intensity between baseline and follow-up. Seventeen women participated in semi-structured interviews. Data were analysed using qualitative content analysis. Results The analysis resulted in three categories with eight subcategories: Experience of improvement included feeling better despite persisting symptoms and to be capable of more activity. Developing strategies for better health included choosing to act to improve health, developing a constructive mental approach to the illness, and changing one’s view of oneself and one’s life. Contextual factors supporting improvement included support from healthcare, social support from one’s environment, and reduced load in daily life. Conclusions Experiences of health improvement involved active changes as well as contextual factors. Clinical implications of this study are that increased knowledge regarding pain management, increased physical activity, and reduced stress could contribute to symptom improvement in persons with CWP.

Unhelpful thoughts and distress regarding symptoms are associated with recovery from upper extremity fracture

BackgroundThere is evidence that thoughts and emotions regarding symptoms are strongly associated with levels of comfort and capability for a given injury or disease. Longitudinal data from a large cohort of people recovering from an upper extremity fracture provided an opportunity to study how these mindset factors evolve during recovery. MethodsSeven hundred and four adults (66% women, mean age 59 ± 21 years) recovering from upper extremity fracture completed two measures of reaction to symptoms (the Pain Catastrophizing Scale and the Tampa Scale of Kinesiophobia), a visual analog scale of pain intensity, and two measures of magnitude of incapability 1 week, 3 to 4 weeks, and 6 to 9 months after fracture. ResultsExploratory factor analysis identified distinct groupings of questions addressing unhelpful thoughts and feelings of distress regarding symptoms. The number of distinct question groupings of mindset factors diminished over time. Variations in those groupings of mindset factors were associated with a notable amount of the variation in comfort and capability at all time points. Questions pertaining to unhelpful thoughts about symptoms had stronger associations with comfort and capability than questions measuring distress about symptoms, more so as recovery progressed. ConclusionsThe need to integrate mental health into musculoskeletal is bolstered by the observation that mindsets—interpretation of symptoms in particular–are key contributors to comfort and capability.

Effect of virtual reality and music therapy on anxiety and perioperative pain in surgical extraction of impacted third molars

BackgroundThe objective of this study was to evaluate the effect of virtual reality (VR) and music therapy on anxiety and perioperative pain in patients undergoing extraction of impacted third molars. MethodsA total of 275 patients who had to undergo surgery for third-molar extraction participated in a randomized controlled trial and were divided into 3 parallel groups: music therapy intervention (n = 91), VR intervention (n = 93), and control (n = 91). The Spielberger State-Trait Anxiety Inventory and the visual analog scale of pain intensity were used as measurements in this study. ResultsPatients in the music therapy and VR groups showed a greater reduction in anxiety level scores after third-molar extraction surgery (reduction in total anxiety in music group: 15.12; 95% CI, 13.16 to 17.08; Rosenthal r, 1.61; P < .001; reduction in total anxiety in VR group: 9.80; 95% CI, 7.66 to 11.95; Rosenthal r, 0.97; P < .001; reduction in total anxiety in control group: 6.63; 95% CI, 4.40 to 8.85; Rosenthal r, 0.62; P < .001). The intensity of pain after the intervention was lower in patients in the music therapy group than patients in the control group (P = .04). After the intervention, the music therapy and VR groups presented a significant decrease in systolic blood pressure (P < .05), diastolic blood pressure (P < .05), and heart rate (P < .05) compared with the control group. ConclusionsThese findings suggest that the use of music therapy and VR during third-molar extraction surgery reduces anxiety and improves the patient’s physiological parameters. Practical ImplicationsImplementation of these interventions (noninvasive, nonpharmacologic, economic) in the field of oral and maxillofacial surgery and dentistry could improve procedures performed under local anesthesia, improving the clinical experience of patients. This clinical trial was registered with the Australian New Zealand Clinical Trials Registry. The registration number is ACTRN12622000384752.

Changes in physical activity and the association between pain and physical activity – a longitudinal analysis of 17,454 patients with knee or hip osteoarthritis from the GLA:D® registry

Investigate change in physical activity following an 8-week education and exercise therapy program for patients with knee/hip osteoarthritis, focusing on those with low physical activity level. Furthermore, to evaluate associations between changes in pain intensity and physical activity. Data from the Good Life with osteoArthritis in Denmark (GLA:D®) registry, at baseline, immediately after completion, and 12 months after entering the program was used. Measures of interest were UCLA activity scale (1-10) and Visual Analog Scale for pain intensity (0-100mm). Changes in physical activity levels (low 1-4, moderate 5-6, and high 7-10) over three time points were investigated. Asymmetric fixed effects regression models were used to evaluate the association between clinically relevant change in pain (≥15mm) and change in physical activity level from baseline to 12 months. 37% with low activity level at baseline (n=4,836) and 69% of all patients (n=17,454) reached or maintained at least a moderate physical activity level at follow-ups. Surprisingly, both an improvement (β=1.44, P<0.001) and a worsening (β=1.18, P<0.001) in pain intensity was associated with increased physical activity in low activity patients. For all patients a similar trend was observed (β=0.51, P<0.001 and β=0.11, P=0.215, respectively). In low active knee or hip OA patients, a third of patients participating in an education and exercise therapy program reached and maintained at least a moderate physical activity level for 1year. The improvement in physical activity was not dependent on pain reduction.

Prospective, Single-arm, Split-face Pain Management Evaluation of Nitrous Oxide System During Micro-Focused Ultrasound With Visualization.

Although micro-focused ultrasound with visualization (MFU-V) has great cosmetic results, patients can be hesitant or decline the treatment due to the pain experienced during the treatment. The primary objective is to assess the efficacy of pain management of the nitrous oxide system during MFU-V treatment. The secondary objectives include patient satisfaction and efficacy on reducing facial laxity and improving aesthetic appearance. A prospective, single-arm, split-face, open-label study. Ten patients were treated with MFU-V without use of a self-administered nitrous oxide system on the right side of the face, followed by use of the nitrous oxide system on the left. A patient-reported Visual Analog Pain Intensity Scale was used to assess pain on the right and left sides at 3 different treatment time points. Patient satisfaction was measured using a 5-point Likert scale and efficacy was measured using the Investigator GAIS and the Facial Laxity Score. Clinically significant differences were seen between pain ratings for the treated and untreated sides at 2 of the 3 time points. 100.0% of patients (n=9) who had completed the study were very satisfied (55.6%) or somewhat satisfied (44.4%). Five patients (55.6%) were scored as Improved on the GAIS and 4 patients (44.4%) were scored as Much Improved. 90.00% (n=9) of patients had moderate lower face and neck laxity prior to treatment, compared with 11.11% (n=1) and 22.22% (n=2) with moderate laxity at follow-up. The nitrous oxide system provides clinically significant pain reduction, increases patient satisfaction, and improves cosmetic results of MFU-V treatment. J Drugs Dermatol. 2022;21(11):1228-1234. doi:10.36849/JDD.7030.

Efficacy of three surgical methods for gingivectomy of permanent anterior teeth with delayed tooth eruption in children

ObjectiveTo compare the efficacy of three surgically assisted permanent anterior tooth eruption methods (laser surgery, electrosurgery and routine surgery) in children.MethodSixty-three orthodontic children with retarded permanent anterior tooth were selected and according to the random number table divided into three groups: laser surgery group (group A), electrosurgery group (group B) and routine surgery group (group C). The total operative time (min), the duration of pain after gingival excision (d), Visual Analogue Scale (VAS) pain intensity scores (0–10 cm), and gingival healing time (d) were all recorded. Six months after treatment, periodontal indexes of the three groups, including gingival indexes (GI), plaque indexes (PLI), probing depth (PD) were checked by the same periodontist and recorded.ResultsSurgical records showed that compared with group C, there were statistically significant differences in operative time, pain duration, pain intensity and healing time in group A and B (P < 0.05). There was no significant difference in these four results between group A and group B. Periodontal examination indicators 6 months after surgery showed no statistical differences in GI, PLI and PD among group A, B and C. Oral clinical examination found that the three groups of patients with different treatment, dental eruption was normal.ConclusionAll the three treatments can effectively solve the problem of delayed eruption of permanent anterior teeth in children. Particularly, laser surgery and high-frequency electrosurgery have good efficacy, little pain and high operability, which can be considered as a better method to aid teeth eruption.

Pilate mat exercise versus muscle energy technique on chronic non specific low back pain

Background: Many studies have been performed to evaluate the best physical therapy technique for treating chronic nonspecific low back pain. Pilate exercises and muscle energy techniques showed favorable results in many trials. Yet, no comparisons were conducted to compare their effects. Purpose: To compare between the effects of pilate mat exercise (PME) and Muscle energy technique (MET) on pain intensity, functional disability, trunk range of motion, and flexibility in patients with chronic non specific low back pain. Subjects: seventy-eight patients diagnosed, by their orthopedist, with chronic non specific low back pain participated in this study. Methods: Patients were divided randomly into three groups: Pilate group: consisted of 29 patients who received PME and standard treatment, MET group: consisted of 29 patients who received MET treatment and standard treatment, Control group: consisted of 29 patients who received standard treatment only. Interventions were performed for 12 sessions (3 sessions/ week) over a period of four weeks. Outcomes were assessed at the beginning and at the end of the fourth week using visual analogue scale for pain intensity, V-sit and reach test (VSR) for flexibility of hamstring and lower back muscles.

Prospective Comparative Study of Fixing Displaced Transverse Patellar Fracture by Tension Band Wiring Versus Cannulated Screws with Wiring

BACKGROUND: Transverse fractures of the patella are important fractures with a wide variety of subtypes, the common incidence in the age group of 20–50 years. Surgical interference aims to achieve a perfect alignment of the joint surface, in addition to rigid fixation of the fracture for early re-habitation and early movement to retain the extensor mechanism of the knee joint. AIM: The aim of this study was to compare the radiological and functional outcomes of the displaced transverse patella fracture in adult patients treated by ORIF using tension band wiring versus cannulated screws with wiring. METHODS: A prospective analytic comparative study was conducted in Al-Kindy Teaching Hospital/Baghdad/Iraq for 18 months from April 1, 2019, to October 1, 2020. It included 32 patients with isolated displaced transverse patellar fracture AO type 34-C1. The patients have undergone operative fixation with two different surgical techniques divided randomly by choosing every other patient into two groups. Group A, the fracture was fixed by cannulated screws with wiring and Group B, the fracture was fixed by two K-wires and with tension band technique. Postoperatively, assessment of the knee function by Lysholm score, the visual analog scale for pain intensity, and active flexion range of movement were measured in degree as primary outcomes, while time to union in weeks assessed radiographically as secondary outcomes. RESULTS: The patients’ age was ranging from 26 to 49 years, with males predominant. Low-energy falls occupying a major part of the mechanism of injury in both groups. Lysholm score was significantly increased after 3, 6, and 12 months compared to that after 1 month in both groups with no statistical differences. The mean visual analog score significantly decreased in Group A after 1 month than that in Group B with no significant change in the other follow-up periods. There were no statistically significant differences in both groups regarding the range of knee movement and the radiographic assessment of fracture healing. CONCLUSION: Both techniques are good and effective with taking into consideration that open reduction and cannulated screws fixation with wiring technique is shown to be associated with lower post-operative pain and a lower frequency of complications mainly surgical site infection.

Changes in the rest-activity rhythm in migraine patients are associated with anxiety symptoms.

To characterize rest-activity rhythm in chronic migraine (CM) and to investigate the relationship between this rhythm and depressive and anxiety symptoms in patients with CM. This was a study of adults aged 20 to 40 years. The rest-activity rhythm of patients with CM (n=23) and non-headache controls (NH, n=23) was assessed by actigraphy for 15 days, and they completed the following assessments: Visual Analogue Scale for pain intensity; Headache Diary; Headache Impact Test-6; Morningness-Eveningness Questionnaire; Pittsburgh Sleep Quality Index; Epworth Sleepiness Scale; Beck Depression Inventory; and State-Trait Anxiety Inventory. Patients with CM showed less activity over 24 hours and more fragmented sleep. Reduced interdaily stability of the rest-activity rhythm was observed, with less robustness of this rhythm in the CM group. Multiple linear regressions revealed a significant association between the rest-activity rhythm and trait anxiety variables in patients with CM, specifically regarding the relative amplitude of the cycle, activity throughout 24 hours and during sleep, and robustness of the rest-activity rhythm. Our findings provide evidence that the robustness of the rest-activity rhythm, activity throughout 24 hours, and sleep fragmentation are associated with trait anxiety in patients with CM.

Effect of sitting position versus walking positions during first stage of labor on pain intensity and labor outcomes among primiparous women

Background: Labor is a physiologic process and consideration of labor pain and relief that is among the major components of maternal care. Application of some labor positions can lay the fetus better in the pelvic canal direction. Aim of the study: to evaluate the pain intensity in the sitting position versus the walking position during the first stage of labor and investigate their effects on labor outcomes among primiparous women. Research design Quasi-experimental research design was utilized to fulfill the aim of this study. Setting: The study was carried out in the labor unit in the obstetric department at Mansoura University Hospital. Sample: Included 100 primiparous women in 1 st stage of labor were recruited in the study, they were divided into two equal groups; a sitting group (50) and a walking group (50) randomly selected through convenient sampling from those who were hospitalized in the previously selected setting with a gestational age of 37–42 weeks, singleton pregnancy, and with cephalic presentation. Tools: Structured Interviewing questionnaire sheet, Structured Observational Checklist including (Partograph and Apgar score), and Visual analogue pain intensity scale (VAS) were used.

Arthroscopic vs open ankle arthrodesis: A prospective case series with seven years follow-up.

BACKGROUNDThe osteoarthritis of the ankle, although less common than other joints, is associated with severe functional limitation. Surgical options are ankle arthroscopic debridement, osteotomies, ankle arthrodesis and ankle arthroplasty. Ankle arthroplasty is increasingly used thanks to the new implants design, but ankle arthrodesis still represents the most used technique and it can be performed arthroscopically or with an open procedure. AIMTo compare mid-term results of arthroscopic vs open ankle arthrodesis of patients affected by end-stage ankle arthritis.METHODSThis study enrolled 23 patients, which underwent ankle arthrodesis. The patients were divided into 2 groups: group A (open procedure; n = 11) and group B (arthroscopic procedure, n = 12), the two groups were homogeneous with regard to age and body mass index (P = 0.347). The American Orthopaedic Foot and Ankle score (AOFAS), Freiburg Ankle score (FAS) and visual analogue scale for pain intensity were evaluated preoperatively, at six months and at final follow-up of 7.6 years in group A and 7.3 years in group B (P = 0.364).RESULTSPatients in the arthroscopic group showed better results at six-month follow-up compared to the open group at the AOFAS (group A, 62.2; group B, 78.5; P < 0.05) and the FAS (group A, 61.1; group B, 70.3; P = 0.015) scores. Pain relief was achieved in both groups at six-month follow-up (group A, 1.4; group B, 0.9; P = 0.162). Both open and arthroscopic groups showed improved clinical outcomes from baseline to final follow-up (P > 0.05). Hospital stay was shorter in group B than in group A (P = 0.001). More complications were reported in the open group than in the arthroscopic group (P = 0.459).CONCLUSIONThe arthroscopic and the open arthrodesis are valid and safe options for the treatment of ankle arthritis on the basis of clinical outcomes at 7 years follow-up. Moreover, the arthroscopic treatment shows faster improvement at six-month follow-up in comparison with the open group.

The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults.

Central nervous system depressant medications (CNSD) including benzodiazepines, z-hypnotics and opioids are regularly prescribed for the older patient. These medications are linked to dependence and associated with severe side effects in some older patients. Consensus recommendations for this group suggest limiting their use. We have recently described a high proportion of long-term CNSD use and dependence among older in-hospital patients. In this study, we aim to investigate factors associated with pain intensity and presentation of pain among older adults with long-term use of CNSDs compared to non-users. Two hundred and forty six elderly hospitalised patients were recruited consecutively in a cross-sectional study. Data was collected from patients and electronic health records (EHR). Independent variables were sex, age, education, emotional symptoms (hospital anxiety and depression scale [HADS]), cognitive function (Mini-mental State Examination test [MMSE]), comorbidity (cumulative illness rating score- geriatrics [CIRS-G]), loneliness (the six-item De Jong Gierveld Loneliness Scale) and prolonged (≥4weeks) use of any CNSDs or prolonged use of opioids (≥4weeks). All variables, including pain intensity, were collected at one time point consistent with the cross-sectional study design. Statistical analyses included descriptive statistics and linear regression models using the above mentioned variables and pain intensity (visual analogue scale for pain intensity [VAS] pain 0-100) as outcome. Additional information regarding pain presentation was extracted from the patients' EHR. Mean pain intensity VAS (SD) was 35.2 (30.4) and 18.1 (24.2) respectively, for patients with vs. without prolonged use of CNSDs. In the multivariable linear regression analysis, prolonged use of CNSDs and opioids were positively associated with pain intensity (VAS) (regression coefficient (95% CI) 20.7 (11.0; 30.3), p<0.001, and 19.8 (5.7; 33.8), p=0.006, respectively), while sex, age, education, MMSE, HADS, CIRS-G and loneliness scores were not. Pain related to back (23.2%) and lower extremities (23.2%) were most common pain sites, and those with one or more pain sites reported overall higher pain intensity compared to those with no reported pain sites (p<0.006). Prolonged use of CNSD medications as well as prolonged use of opioids are both positively associated with pain intensity. The results may have implications for treatment and long-term pain management for older patients.

Validity and reliability of the Mini-Osteoarthritis Knee and Hip Quality of Life scale in Turkish population.

Objectives This study aims to investigate the validity and reliability of the Turkish version of the Mini-Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQoL) scale developed to assess the quality of life (QoL) in patients with knee and/or hip osteoarthritis.Patients and methods Between May 2018 and May 2020, a total of 83 patients (11 males, 72 females; mean age: 58.1±10.0 years; range, 39 to 81 years) with knee and/or hip osteoarthritis were included. Demographic, clinical, and survey data (Mini-OAKHQoL, Nottingham Health Profile, Short Form-36, Western Ontario and McMaster Universities Osteoarthritis Index, Lequesne Index, and Visual Analog Scale of pain intensity) were recorded. Missing data, floor effect, and ceiling effect were calculated. For reliability analysis, internal consistency and test-retest reliability were discovered. Face, content, convergent, and divergent validities were applied.Results Among the patients, 52 (62.65%) had knee osteoarthritis, 26 (31.32%) had hip osteoarthritis, and five (6.02%) had both. Mini-OAKHQoL had a good face and content validity. The average item completion rate was 96.9%, with the time needed to perform was about 4 min. None of the subscales of Mini-OAKHQoL presented floor or ceiling effect, with a good range of responses. The Cronbach alpha coefficients and intraclass correlation coefficient (ICC) analysis of the subscales ranged from 0.927 to 0.676 and 0.987 to 0.843, respectively. Regarding convergent validity, the physical activities, mental health, and pain subscales of Mini-OAKHQoL had moderate to high correlations with the topic-related subset of the other QoL surveys. There were no or weak correlations between Mini-OAKHQoL and non-QoL parameters, indicating its divergent validity.Conclusion The Turkish version of Mini-OAKHQoL is a valid, reliable, simple, practical, accurate, completable, comprehensive, and disease-specific self-report instrument to assess QoL in patients with knee and/or hip osteoarthritis.

Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial

Background: A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic lower back pain. Objectives: Viable disc allograft was injected into painful degenerated discs to evaluate safety and determine whether it can improve pain and function. Study Design: Patients received an active treatment of allograft or saline, or continued with nonsurgical management (NSM). Prior to entering the study, patients had back pain for a minimum of 6 months before treatment that was recalcitrant to nonoperative treatment modalities. Standardized outcome measures were used to evaluate the patient’s condition before and after treatment. Primary endpoints included improvement in Oswestry Disability Index (ODI) and Visual Analog Scale of Pain Intensity (VASPI). Conventional radiographs and magnetic resonance imaging scans were used to assess disc space height and spinal alignment, and to determine the degree of disc degeneration. Patients were followed for one year after enrollment. The NSM group could cross over to the allograft group after 3 months. Setting: This multicenter trial was completed in outpatient surgical centers and office injection suites. A total of 218 patients with chronic low back pain secondary to single-level or 2-level degenerative disc disease were enrolled. Inclusion criteria included pretreatment VASPI &gt;= 40 mm, ODI score &gt;= 40 and symptoms present longer than 6 months. Patients were blinded and randomized to receive intradiscal injections of either viable disc allograft or saline. Patients randomized to the NSM group continued existing treatment. Patients were assessed at 6 and 12 months. Adverse events (AEs) were continually assessed. Methods: The VAST trial is a prospective, multicenter, blind, randomized clinical trial (RCT) for patients with single-level or 2-level degenerative lumbar disc disease. Results: At 12 months, clinically meaningful improvements in mean VASPI and ODI scores were achieved in the investigational allograft and saline groups. A responder analysis demonstrated a clinically meaningful reduction in ODI of &gt;= 15 points at 12 months that was statistically significant; 76.5% of patients randomized to allograft were responders (P = 0.03) compared to 56.7% in the saline group. A responder group characterized by a ? 20 point reduction in pain at 12 months achieved a statistically significant reduction in pain compared to the saline group (P = 0.022). In the allograft group, 11 safety adverse events occurred in 141 patients (3.5%) and there were no persistently symptomatic AEs. Limitations: Limitations of this study include a comparison to saline that has been shown to be more representative of an active comparator as opposed to a placebo. In addition, 36 patients were lost to follow-up; this loss resulted in the saline and NSM/crossover groups being smaller than the predetermined group size to have an appropriately powered analysis. Conclusions: This large, prospective blinded RCT demonstrated safety and efficacy results indicating that viable disc tissue allograft may be a beneficial nonsurgical treatment for patients who have chronically painful lumbar degenerative discs. Further studies would be optimal to confirm efficacy Key words: Viable disc tissue allograft, discogenic back pain, allograft supplementation, degenerative disc disease, low back pain, intervertebral disc, intradiscal injection

Using a postoperative pain trajectory to predict pain at 1 year after total knee arthroplasty

BackgroundThe pain trajectory is an early detection/prediction method for chronic postsurgical pain (CPSP). It is unclear whether a pain trajectory can predict CPSP in patients who have undergone a total knee arthroplasty (TKA). Here we investigated (1) whether CPSP can be predicted in TKA patients, and (2) the values that can be used to predict CPSP. MethodsWe studied 211 postoperative TKA patients. We calculated the pain trajectory (pain curve slope and intercept) using the patients’ self-reported pain intensity values at 1, 3, 5, and 7 days post-TKA. Using structural equation modeling (SEM), we performed a multiple regression analysis to investigate appropriate prediction models for the pain trajectory. Classification and regression tree (CHAID) methodology was used to calculate values to predict CPSP by a decision tree model. CPSP (dependent variable) was defined as >30 mm on a visual analog scale for pain intensity at 1 year post-TKA. The predictor variables were pain curve slope, intercept, age, sex, body mass index, and preoperative pain intensity. ResultsThe pain trajectory was the best fit among the models to predict pain intensity at 1 year post-TKA. When the pain curve slope (pain trajectory) was greater than 2.8, the probability of CPSP at 1 year post-TKA was 33.3%. ConclusionOur results suggest that the pain trajectory could be applied to post-TKA patients and used to calculate clinical values to predict CPSP. Our findings also indicate the possibility that patients with a positive pain curve slope in the first postoperative week may need early intervention to avoid CPSP.

58. Viable disc tissue allograft supplementation in the treatment of degenerated intervertebral discs the one-year results of a randomized control trial

58. Viable disc tissue allograft supplementation in the treatment of degenerated intervertebral discs the one-year results of a randomized control trial

91. The viable disc tissue allograft supplementation (VAST) randomized controlled trial in patients with chronic discogenic low back pain: Correlating age with clinical outcome

<h3>BACKGROUND CONTEXT</h3> The development of chronic low back pain (LBP) results from internal disc disruption within the nucleus pulposus and is the most common etiology of LBP in young to middle-age adults. A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic LBP. <h3>PURPOSE</h3> In this study, the clinical outcomes of patients in the VAST study were analyzed on the basis of patient age (above and below the median age of all patients). <h3>STUDY DESIGN/SETTING</h3> Randomized, controlled, multicenter study in US. <h3>PATIENT SAMPLE</h3> A total of 218 patients with chronic low back pain secondary to single-level or two-level degenerative disc disease were enrolled in the study. Patients had back pain for a minimum of 6 months that was recalcitrant to nonoperative treatment modalities. Inclusion criteria also included pretreatment VASPI ≥ 40 and ODI Score ≥ 40. <h3>OUTCOME MEASURES</h3> Oswestry Disability Index (ODI) and visual analog scale of pain intensity (VASPI), neurological exam and adverse events. Plain film radiographs and magnetic resonance (MR) imaging scans were used to assess disc space height and spinal alignment and to determine the degree of disc degeneration. <h3>METHODS</h3> Prospective, multicentered, blinded, randomized clinical trial for subjects with single or two-level degenerative lumbar disc disease was conducted. Patients had back pain for a minimum of 6 months, which was recalcitrant to nonoperative treatment modalities. Patients were blinded and randomized to receive intradiscal injections of either viable disc allograft or saline, or to continue nonblinded with nonsurgical management (NSM). The NSM group could cross over to the allograft group after 3 months. All patients crossed over into the investigational allograft treatment group. Patient data based on age comparing younger patients (19-42 years, 104 patients) to older patients (43-73 years, 114 patients) across all three groups were analyzed. Statistical analyses were performed based on 12-month post treatment improvements in ODI and VAS. <h3>RESULTS</h3> In the younger patient group, a significantly larger improvement in ODI of 29.7 points in the allograft treated group and 45.0 points in the cross over group was observed vs 17.4 points with the saline group (Overall p-value =.004). This effect was also observed in multiple responder analyses with a significantly higher percentage of allograft-treated patients demonstrating ≥15 and ≥20-point improvements in ODI vs the saline group. 69.1% of the younger patients treated with viable allograft vs 35.3% of the saline group showed clinically meaningful improvement of ODI ≥20-points (Overall p-value=.004). No significant interaction between treatment and age in VAS, and no significant benefits of allograft treatment on VAS in younger vs older patients was observed. Adverse events were reported in 30.9%, 10.5% and 17.6% of younger patients in the allograft, placebo, and conservative care groups, respectively (overall p value=0.155), compared to 28.8%, 15.8%, and 9.1% of older patients in these groups (overall p value=0.136), most commonly back pain. <h3>CONCLUSIONS</h3> This subgroup analysis indicates that younger patients (≤ 42 years) have more favorable clinical outcome vs older patients at 12 months. This data suggests that a viable disc tissue injection can effectively treat chronic discogenic LBP nonsurgically with meaningful results demonstrated in a younger patient population. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.