scholarly journals A  Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Ahmadreza Jamshidi ◽  
Farhad Gharibdoost ◽  
Sima Sedighi ◽  
Asghar Hajiabbasi ◽  
Amir-Hossein Salari ◽  
...  
Keyword(s):  
Back Pain ◽  
Safety Concern ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Life Questionnaire ◽  
Vas Score ◽  
Vas Scores ◽  
The Mean ◽  
Iranian Patients ◽  
Phase Iv

The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar®, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 μg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant ( p < 0.001 ). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.

scholarly journals Short-Term Effect of Lumbar Traction on Intervertebral Discs in Patients with Low Back Pain: Correlation between the T2 Value and ODI/VAS Score

Cartilage ◽  
2021 ◽  
pp. 194760352199679
Author(s):  
Zhen-zhen Liu ◽  
Hui-quan Wen ◽  
Ye-qing Zhu ◽  
Bin-liang Zhao ◽  
Qing-cong Kong ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
T2 Mapping ◽  
Low Back ◽  
Vas Score ◽  
Grade Ii ◽  
Lumbar Traction ◽  
Vas Scores ◽  
The Mean ◽  
Pfirrmann Grade

Objective The effect of lumbar traction on low back pain (LBP) patients is controversial. Our study aims to assess changes in the intervertebral disc water content after lumbar traction using T2 mapping and explore the correlation between changes in the T2 value and Oswestry Disability Index (ODI)/visual analogue scale (VAS) score. Design Lumbar spine magnetic resonance imaging was performed, and the ODI/VAS scores were recorded in all 48 patients. Midsagittal T2-weighted imaging and T2 mapping were performed to determine the Pfirrmann grade and T2 value. Then, the T2 values were compared between pre- and posttraction, and the correlation between changes in the T2 value and ODI/VAS scores were examined. Results In the traction group, the changes in the nucleus pulposus (NP) T2 values for Pfirrmann grades II-IV and the annulus fibrosus (AF) T2 values for Pfirrmann grade II were statistically significant after traction ( P < 0.05). Changes in the mean NP T2 value of 5 discs in each patient and in the ODI/VAS score showed a strong correlation ( r = 0.822, r = 0.793). Conclusion T2 mapping can be used to evaluate changes in the intervertebral disc water content. Ten sessions of traction resulted in a significant increase in quantitative T2 measurements of the NP in discs for Pfirrmann grade II-IV degeneration and remission of the patients’ clinical symptoms in the following 6 months. Changes in the mean NP T2 value of 5 discs in each patient were strongly correlated with changes in the ODI/VAS score.

scholarly journals OP0028 EFFICACY OF APREMILAST FOR THE PAIN OF ORAL ULCERS ASSOCIATED WITH ACTIVE BEHÇET’S SYNDROME: 12-WEEK RESULTS FROM THE RANDOMIZED, PHASE III RELIEF STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 20.2-21
Author(s):  
G. Hatemi ◽  
A. Mahr ◽  
M. Takeno ◽  
D. Kim ◽  
M. Melikoglu ◽  
...  
Keyword(s):  
Phase Iii ◽  
Controlled Study ◽  
Behçet’S Syndrome ◽  
Research Support ◽  
Behçet's Syndrome ◽  
Oral Ulcers ◽  
Behcet’S Syndrome ◽  
Vas Scores ◽  
The Mean ◽  
Behcet's Syndrome

Background:Oral ulcers (OU) associated with Behçet’s syndrome are often painful, may interfere with the ability to eat and can negatively affect quality of life.1,2Apremilast (APR), an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in the treatment of OU associated with Behçet’s syndrome in a phase III, multicenter, randomized, double-blind, placebo (PBO)-controlled study (RELIEF; BCT-002).3Objectives:To describe the efficacy of APR treatment in improving OU pain associated with Behçet’s syndrome in RELIEF.Methods:Patients were randomized (1:1) to APR 30 mg twice daily (APR 30 BID) or PBO twice daily for a 12-week PBO-controlled phase, followed by a 52-week active treatment extension. Eligible patients were ≥18 years of age and had active Behçet’s syndrome with ≥3 OU at randomization or ≥2 OU at screening and randomization and without active major organ involvement. Clinical improvement in OU was evaluated by the area under the curve for the number of OU through Week 12 (AUCWk0-12; primary efficacy endpoint) and by assessments of OU number. Patient-reported OU pain was evaluated by the 100-mm visual analogue scale (VAS). The statistical tests were 2-sided (α=0.05). The proportions of patients achieving the minimal clinically important difference (MCID) and higher rates of improvement, defined as ≥10-mm,4≥30-mm (3-fold MCID), ≥50-mm (5-fold MCID) improvements in OU pain VAS scores, respectively, were analyzed through Week 12. An ANCOVA model was used to analyze the primary endpoint and assessments of OU number and OU pain (VAS). The proportion of patients achieving improvement in OU pain VAS scores at Week 12 were summarized descriptively.Results:A total of 207 patients were randomized and received ≥1 dose of study medication (APR: n=104; PBO: n=103). At baseline, the mean (SD) number of OU was 4.2 (3.7) in the APR 30 BID group and 3.9 (2.7) in the PBO group, and the mean (SD) OU pain VAS scores were 61.2 (27.6) and 60.8 (26.9), respectively. At Week 12, significantly greater improvements were observed with APR 30 BID vs. PBO in AUCWk0-12(least-squares [LS] mean [SE]: 129.5 [15.9] vs. 222.1 [15.9];P<0.0001), number of OU (LS mean [SE]: 1.1 [0.2] vs. 2.0 [0.3];P=0.0003) and OU pain VAS scores (LS mean [SE] change from baseline: −40.7 [3.3] vs. −15.9 [3.3];P<0.0001). The proportion of patients who achieved the MCID of ≥10-mm improvement in OU pain VAS scores at Week 12 was greater with APR 30 BID vs. PBO; this pattern was also observed for the higher 3- and 5-fold improvements in MCID (Figure 1). Greater proportions of APR 30 BID vs. PBO patients achieved ≥10-mm and ≥30-mm improvements in OU pain VAS scores over 12 weeks. Notably, greater achievement of ≥50-mm improvement in OU pain VAS scores was observed with APR 30 BID vs. PBO as early as Week 1 and maintained up to Week 12 (Figure 2).Conclusion:For patients with active Behçet’s syndrome, APR 30 BID provided significantly greater improvements vs. PBO in OU number and OU pain at Week 12, including the greater proportion of patients achieving MCID and 3- and 5-fold MCID of OU pain in the APR 30 BID group vs. the PBO group. These results indicate a clinically meaningful treatment effect of APR 30 BID on the OU associated with Behçet’s syndrome.References:[1]Kokturk A.Patholog Res Int. 2012;2012:690390.[2]Hatemi G, et al.Ann Rheum Dis. 2008;67:1656-1662.[3]Hatemi G, et al.N Engl J Med. 2019;381:1918-1928. 4. Dworkin RH, et al.J Pain. 2008;9:105-121.Disclosure of Interests:Gulen Hatemi Grant/research support from: BMS, Celgene Corporation, Silk Road Therapeutics – grant/research support, Consultant of: Bayer, Eli Lilly – consultant, Speakers bureau: AbbVie, Mustafa Nevzat, Novartis, UCB – speaker, Alfred Mahr Consultant of: Celgene, Speakers bureau: Roche, Chugai, Mitsuhiro Takeno Speakers bureau: Esai, Tanabe-Mitsubishi – speaker; Celgene Corporation – advisory board, Doyoung Kim: None declared, Melike Melikoglu: None declared, Sue Cheng Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Shannon McCue Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Sven Richter Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Michele Brunori Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Maria Paris Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Mindy Chen Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of the conduct, Yusuf Yazici Consultant of: BMS, Celgene Corporation, Genentech, Sanofi – consultant, Consultant of: BMS, Celgene Corporation, Genentech, Sanofi – consultant

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

SAT0416 ENTHESITIS AND CLINICAL RESPONSE IN PSORIATIC ARTHRITIS: REAL-LIFE DATA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1161.1-1161
Author(s):  
S. Ganhão ◽  
S. Garcia ◽  
B. M. Fernandes ◽  
M. Rato ◽  
F. Pinheiro ◽  
...  
Keyword(s):  
Back Pain ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Real Life ◽  
Inflammatory Back Pain ◽  
Skeletal Involvement ◽  
Vas Score ◽  
Das 28 ◽  
The Mean

Background:Psoriatic arthritis (PsA) is an inflammatory arthritis that is characterized by a broad spectrum of clinical conditions, including axial skeletal involvement, enthesitis, dactylitis, uveitis and arthritis. Among those, enthesitis, the inflammation of the junction where the tendon, ligament or joint capsule inserts into the bone, is assigned to be the hallmark, affecting 35–50% of patients. Several clinical methods have been developed to measure it, including The Maastricht AS Enthesitis Score (MASES) index, which tests 13 entheses and the Spondyloarthritis Research Consortium of Canada (SPARCC) index that assesses 16.Objectives:To assess the relationship between enthesitis and clinical response in psoriatic arthritis.Methods:Retrospective study including all the patients with PsA meeting the CASPAR criteria, beginning first-line biologic therapy at our centre. Demographic and clinical data including age, gender, body mass index (BMI), smoking status, physical examination findings such as presence of enthesitis, dactylitis, chronic back pain, tender and swollen joint counts (TJC/ SJC), ESR, CRP, DAS 28 4vESR, BASDAI, BASFI, BASMI, ASDAS, HAQ, patient VAS score, MASES and SPARCC were collected from the Portuguese database Reumapt. Statistical analysis was performed with SPSS. Continuous variables were analysed through Spearman correlations.Results:We included 119 patients with PsA (60 female), of which 14.9% were active smokers. The mean age of patients was 46.3 ± 1.03 years. The median disease duration was 6.8 (0.3-33.8) years and the mean BMI was 26.8 ± 0.5 Kg/m2.Enthesitis, dactylitis, inflammatory back pain, peripheral arthritis, ungueal distrophy, and psoriasis were present in 53 (45.7%), 45 (38.8%), 76 (65.5%), 109 (94%), 45 (38.8%), 104 (89.7%) patients, respectively.At baseline, mean (SD) disease activity parameters were: DAS 28 4vESR 4.9 (0.2), ESR 33.2 (2.3) mm/h; CRP 2.35 (0.3) mg/dL, HAQ 1.3 (0.1), BASDAI 6.6 (0.2), ASDAS 3.9 (0.1), BASMI 3.7 (0.2), BASFI 5.8 (0.3), MASES 1.9 (0.3), SPARCC 2.3 (0.3). Median (min-max) values of TJC, SJC and patient VAS score at baseline were 4 (0-28), 3 (0-19), 76 (0-100), respectively.There were statistically significant positive correlations (0-12 months) between ΔMASES and ΔDAS 28 4vESR (p=0.02, rho=0.432), Δpatient VAS score (p=0.027, rho=0.307), ΔHAQ (p=0.02, rho=0.411), ΔBASDAI (p=0.025, rho=0.326), ΔBASFI (p=0.037, rho=0.315), ΔASDAS (p=0.023, rho= 0.331). Correlations between ΔSPARCC and ΔDAS 28 4vESR (p=0.023, rho=0.332), Δpatient VAS score (p=0.003, rho=0.402), ΔHAQ (p=0.012, rho=0.440), ΔBASDAI (p=0.011, rho=0.368), ΔBASFI (p=0.001, rho=0.445), ΔASDAS (p=0.002, rho= 0.437), ΔCDAI (p=0.039, rho=0.320) and ΔSDAI (p=0.039, rho=0.319), were also significant. However, there weren’t strong correlations between ΔMASES neither ΔSPARCC and PsARC response at 12 months.Conclusion:Our results suggest that enthesitis is correlated with clinical response in PsA, supporting the idea that it is a major determinant of disease activity. It should be given more importance, namely by incorporating it in daily clinical practice, due to its major role, both in establishing an early diagnosis and in assessing treatment response.References:[1]Sunar I, Ataman S, Nas K, Kilic E, Sargin B, Kasman SA, et al. Enthesitis and its relationship with disease activity, functional status, and quality of life in psoriatic arthritis: a multi‑center study. Rheumatol Int. 2019 Nov 26. doi: 10.1007/s00296-019-04480-9.Disclosure of Interests:Sara Ganhão: None declared, Salomé Garcia: None declared, Bruno Miguel Fernandes: None declared, Maria Rato: None declared, Filipe Pinheiro: None declared, Eva Mariz: None declared, Miguel Bernardes Speakers bureau: Abbvie, Amgen, Biogen, Eli-Lilly, Glaxo-Smith-Kline, Pfizer, Janssen, Novartis, Lúcia Costa: None declared

The efficacy of microendoscopic discectomy in reducing iatrogenic muscle injury

2008 ◽  
Vol 8 (1) ◽  
pp. 39-43 ◽  
Author(s):  
Dong Ah Shin ◽  
Keung Nyun Kim ◽  
Hyun Cheol Shin ◽  
Do Heum Yoon
Keyword(s):  
Back Pain ◽  
Lactate Dehydrogenase ◽  
Muscle Injury ◽  
Creatine Phosphokinase ◽  
Serum Levels ◽  
Analog Scale ◽  
Vas Scores ◽  
Microendoscopic Discectomy ◽  
The Mean ◽  
Herniated Nucleus Pulposus

Object The objective of this study was to evaluate the invasiveness of microendoscopic discectomy (MED) in comparison with microscopic discectomy (MD) by measuring serum levels of creatine phosphokinase (CPK)-MM and lactate dehydrogenase (LDH)-5, and by comparing visual analog scale (VAS) scores of postoperative pain. Methods This study included a group of 15 patients who underwent surgery using MED and 15 patients who underwent surgery using MD, both for single-level unilateral herniated nucleus pulposus. The CPK-MM and LDH-5 levels were measured at admission and after 1, 3, and 5 days postoperatively. Pain assessment was recorded using scores raging from 0 to 10 on a subjective VAS at admission and at 1, 3, and 5 days postoperatively. Results The mean CPK-MM levels were lower for the MED group than for the MD group at both 3 (576.1 ± 286.3 IU/L compared with 968.1 ± 377.8 IU/L) and 5 days (348.1 ± 231.0 IU/L compared with 721.7 ± 463.2) postoperatively (p < 0.05). The mean VAS scores for postoperative back pain were lower in the MED group than in the MD group, both at 1 (3.3 ± 2.3 compared with 5.8 ± 1.5) and 5 days (1.9 ± 1.1 compared with 3.6 ± 1.1) postoperatively (p < 0.01). Conclusions The MED procedure is less invasive than MD, and causes less muscle damage and less back pain.

scholarly journals Outcomes of decompression without fusion in patients with lumbar spinal stenosis and substantial back pain

2021 ◽  
pp. 1-4
Author(s):  
Rachid Bech-Azeddine ◽  
Søren Fruensgaard ◽  
Mikkel Andersen ◽  
Leah Y. Carreon
Keyword(s):  
Back Pain ◽  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Structural Instability ◽  
Radicular Pain ◽  
Leg Pain ◽  
Neurogenic Claudication ◽  
Vas Score ◽  
The Mean ◽  
Lumbar Spinal

OBJECTIVEThe predominant symptom of lumbar spinal stenosis (LSS) is neurogenic claudication or radicular pain. Some surgeons believe that the presence of substantial back pain is an indication for fusion, and that decompression alone may lead to worsening of back pain from destabilization associated with facet resection. The purpose of this study was to determine if patients with LSS and clinically significant back pain could obtain substantial improvements in back pain after a decompression alone without fusion.METHODSThe DaneSpine database was used to identify 2737 patients with LSS without segmental instability and a baseline back pain visual analog scale (VAS) score ≥ 50 who underwent a decompression procedure alone without fusion. Standard demographic and surgical variables and patient outcomes, including back and leg pain VAS score (0–100), Oswestry Disability Index (ODI), and EQ-5D at baseline and at 12 months postoperatively, were collected.RESULTSA total of 1891 patients (69%) had 12-month follow-up data available for analysis; the mean age was 66.4 years, 860 (46%) were male, the mean BMI was 27.8 kg/m2, and 508 (27%) were current smokers. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for back pain (72.1 to 42.1), leg pain (71.2 to 41.3), EQ-5D (0.35 to 0.61), and ODI (44.1 to 27.8).CONCLUSIONSPatients with LSS, clinically substantial back pain, and no structural instability obtain improvement in back pain after decompression-only surgery and do not need a concomitant fusion.

scholarly journals The Effectiveness of Thai Massage and Joint Mobilization

2017 ◽  
Vol 10 (2) ◽  
pp. 3
Author(s):  
Chantip Juntakarn, MA ◽  
Thavat Prasartritha, MD ◽  
Prapoj Petrakard, MD
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Outcome Measures ◽  
Randomized Study ◽  
Secondary Outcome ◽  
Control Group ◽  
Low Back ◽  
Short Term ◽  
Joint Mobilization ◽  
The Mean

Background: Non-specific low back pain (LBP) is a common health problem resulting from many risk factors and human behaviors. Some of thesemay interact synergistically and have been implicated in the cause of low back pain. Massage both traditional Thai massage and joint mobilization as a common practice has been shown to be effective for some subgroup of nonspecific LBP patients.Purpose and Setting: The trial compared the effectiveness between traditional Thai massage and joint mobilization for treating nonspecificLBP. Some associated factors were included. The study was conducted at the orthopedic outpatient department, Lerdsin General Hospital, Bangkok, Thailand.Methods: Prospective, randomized study was developed without control group. The required sample size was estimated based on previouscomparative studies for effectiveness between techniques. Two primary outcome measures were a 0 to 10 visual analog scale (VAS) of pain andOswestry Disability Index (ODI). Secondary outcome measures were satisfaction of patients and adverse effects of the treatment. The ‘‘intention to treat’’ (ITT) and per protocol approach were used to compare the significance of the difference between treatment groups.Participants: One hundred and twenty hospital outpatients, 20 (16.7%) male and 100 (83.3%) female, were randomized into traditional Thai massage and joint mobilization therapy. The average age of traditional Thai massage and joint mobilization was 50.7 years and 48.3 years, respectively. Both groups received each treatment for approximately 30 minutes twice per week over a four-week period. Total course did not exceed eight sessions.Result: With ITT, the mean VAS of traditional Thai massage group before treatment was 5.3 (SD = 1.7) and ODI was 24.9 (SD = 14.7), while in jointmobilization groups, the mean VAS was 5.0 (SD = 1.6) and ODI was 24.6 (SD = 15). After treatment, the mean VAS and ODI were significantlyreduced (VAS = 0.51 (SD = 0.89) and ODI = 8.1 (SD = 10.7) for traditional Thai massage, VAS = 0.86 (SD = 1.49) and ODI = 8.26 (SD = 12.97) for joint mobilization). Constipation was found in 34 patients (28.3%).Conclusion: The traditional Thai massage and joint mobilization used in this study were equally effective for short-term reduction of pain and disability in patients with chronic nonspecific LBP. Both techniques were safe with short term effect in a chosen group of patients.

scholarly journals Paired comparison between water and nutrient drink tests in healthy volunteers

2009 ◽  
Vol 46 (4) ◽  
pp. 304-310 ◽  
Author(s):  
Vasileios Papadopoulos ◽  
Maria Fragaki ◽  
Konstantinos Mimidis
Keyword(s):  
Fluid Intake ◽  
Paired Comparison ◽  
Multiple Regression Model ◽  
Burning Sensation ◽  
Normal Volunteers ◽  
Vas Score ◽  
Normal Individuals ◽  
Vas Scores ◽  
The Mean ◽  
Drink Test

CONTEXT: Drink tests constitute an inexpensive and non-invasive tool, which has been proposed to discriminate individuals with altered fluid intake, as dyspeptics. However, their use in everyday clinical practice is still limited as standardization still lacks. OBJECTIVE: To perform a direct, paired comparison between the water and the nutrient drink test in normal volunteers. METHODS: Thirty eight normal volunteers (19 males, 19 females, mean age 24.4 ± 0.4 years) underwent drink test with water and nutrient (Nutridrink) within 7-10 days. Both tests included a loading (consumption of 100 mL/min for water and 15 mL/min for Nutridrink for the longest possible period of time) and a recuperation phase (observation after cessation of fluid intake), being separated by the maximal saturation point. During phases, satiety, fullness, discomfort, bloating, belching, nausea, pain and burning sensation (epigastric and thoracic) were recorded using a 0-100 visual analogue scale score (VAS). For the purpose of configuration, four variables were considered: time (t), VAS score (V), VAS slope (S) for a given time period, and probability of participation (Q) at a given timepoint. RESULTS: The loading phase lasted for 11.6 ± 1.7 min in water (total VAS: 879 ± 123, total VAS slope 72.6 ± 10.9 min-1) and 93.3 ± 18.4 min in Nutridrink test (total VAS: 1462 ± 411, total VAS slope 15.9 ± 3.2 min-1); P<0.001. The mean ingested volume recorded was 1155 ± 164 mL for water and 1399 ± 276 mL for nutrient; P = 0.076. Cessation of fluid intake was mainly attributed to fullness (76.3%) in water and satiety (69.2%) in Nutridrink test. Nausea was recorded only in Nutridrink test (15.4%). No volunteer reported substantial, persistent pain or burning sensation. The recuperation phase lasted 63.6 ± 7.8 min in water (total VAS: 278 ± 75, total VAS slope 3.97 ± 0.95 min-1) and 123.2 ± 17.5 min in Nutridrink test (total VAS: 841 ± 126, total VAS slope 6.81 ± 1.63 min-1); P<0.001. Concerning total VAS scores for both phases of the two tests, fullness and satiety represented a mere four fifths of the total (43% and 36%, respectively). Belching (8%), bloating (6%), nausea (4%), and discomfort (3%) followed, while pain and burning sensation represented <1% of the whole. However, intra- and intertest correlations concerning total and symptom-specific VAS scores revealed statistically significant variations underlying differences in physiology of liquid intake. A multiple regression model considering body mass index, gender and age as dependent variables, and total and symptom-specific VAS scores and slopes for both phases of the two tests as independent variables, did not reveal any primary correlation. The function linking the expected probability of participation Q and symptom-specific VAS score V with time t is approached by the formulas Q(t)=1/[1+(t/c)^k] and V(t)=V0*e^(-t/c), respectively; V0 is the mean symptom-specific VAS score, c, and k are phase- and test- related constants, and e = 2.718 is the base of natural logarithms. CONCLUSION: The comparative standardization of both drink tests in normal individuals might provide a tool for clinical application, targeting the diagnosis and treatment of relevant functional disorders.

scholarly journals Minimally Invasive Transforaminal Lumbar Interbody Fusion: An Attractive Option for Select Failed Backs

2018 ◽  
Vol 12 (1) ◽  
pp. 52-58 ◽  
Author(s):  
Arvind G. Kulkarni ◽  
Shashidhar Bangalore Kantharajanna ◽  
Abhilash N. Dhruv
Keyword(s):  
Back Pain ◽  
Blood Loss ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Percentage Change ◽  
Leg Pain ◽  
Lumbar Interbody Fusion ◽  
Vas Scores ◽  
The Mean

<sec><title>Study Design</title><p>Retrospective case series.</p></sec><sec><title>Purpose</title><p>To compare minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) outcomes in primary and revision surgeries.</p></sec><sec><title>Overview of Literature</title><p>Revision spinal fusion is often associated with an increased risk of approach-related complications. Patients can potentially benefit from the decreased approach-related morbidity associated with MI-TLIF.</p></sec><sec><title>Methods</title><p>Sixty consecutive MI-TLIF patients (20 failed back [Fa group], 40 primary [Pr group]) who underwent surgery between January 2011 and May 2012 were reviewed after Institutional Review Board approval to compare operative times, blood loss, complications, Oswestry Disability Index (ODI) scores, and Visual Analog Scale (VAS) scores for back and leg pain before surgery and at the last follow-up.</p></sec><sec><title>Results</title><p>Nineteen revision surgeries were compared with 36 primary surgeries. One failed back and four primary patients were excluded because of inadequate data. The mean follow-up times were 28 months and 24 months in the Pr and Fa groups, respectively. The mean pre- and postoperative ODI scores were 53.18 and 20.23 in the Pr group and 52.01 and 25.72 in the Fa group, respectively (ODI percentage change: Pr group, 60.36%±29.73%; Fa group, 69.32%±13.72%; <italic>p</italic>=0.304, not significant). The mean pre- and postoperative VAS scores for back pain were 4.77 and 1.75 in the Pr group and 4.1 and 2.0 in the Fa group, respectively, and the percentage changes were statistically significant (VAS back pain percentage change: Pr group, 48.78±30.91; Fa group, 69.32±13.72; <italic>p</italic>=0.027). The mean pre- and postoperative VAS scores for leg pain were 6.52 and 1.27 in the Pr group and 9.5 and 1.375 in the Fa group, respectively (VAS leg pain percentage change: Pr group, 81.07±29.39; Fa group, 75.72±15.26; <italic>p</italic>=0.538, not significant). There were no statistically significant differences in operative time and estimated blood loss and no complications.</p></sec><sec><title>Conclusions</title><p>MI-TLIF outcomes were comparable between primary and revision surgeries. The inherent technique of MI-TLIF is particularly suitable for select failed backs because it exploits the intact paramedian corridor.</p></sec>

scholarly journals Clinical results following robotic navigation guidance for sacroiliac joint fusion in 36 patients

2022 ◽  
Vol 52 (1) ◽  
pp. E6
Keyword(s):  
Clinical Improvement ◽  
Sacroiliac Joint ◽  
Clinical Results ◽  
Guidance System ◽  
Robotic Navigation ◽  
Vas Score ◽  
Patient Reported ◽  
Vas Scores ◽  
The Mean

OBJECTIVE In this study, the authors aimed to describe a new technique of sacroiliac joint (SIJ) fusion using a robotic navigation guidance system and to document clinical results with patient-reported visual analog scale (VAS) scores. METHODS Patients diagnosed with SIJ dysfunction were surgically treated using 2 hydroxyapatite (HA)–coated, threaded screws with the aid of the robotic navigation system. In a total of 36 patients, 51 SIJs were fused during the study period. Patients’ VAS scores were used to determine clinical improvement in pain. Postoperative imaging at routine intervals during the follow-up period was also performed for assessment of radiological fusion. In addition, complication events were recorded, including reoperations. RESULTS All 36 patients had successful fusion evidenced by both CT and clinical assessment at the final follow-up. Two patients underwent reoperation because of screw loosening. The mean preoperative VAS score was 7.2 ± 1.1, and the mean 12-month postoperative VAS score was 1.6 ± 1.46. This difference was statistically significant (p < 0.05) and demonstrated a substantial clinical improvement in pain. CONCLUSIONS Robotic navigation–assisted SIJ fusion using 2 HA-coated, threaded screws placed across the joint was an acceptable technique that demonstrated reliable clinical results with a significant improvement in patient-reported VAS pain scores.

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