Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study

Pain Medicine ◽  
2020 ◽  
Vol 21 (11) ◽  
pp. 2713-2718
Author(s):  
Dimitrios Papadopoulos ◽  
Chrysanthi Batistaki ◽  
Georgia Kostopanagiotou

Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.

2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  

Abstract Background Hair loss is one of the most common side effects of chemotherapy, and can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there are no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction, YH0618, could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effects of chemotherapy. Besides, the theory of Chinese Medicine believes that the “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/design Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contain taxanes or/and anthracyclines, and the chemotherapy regimen will be for at least six cycles with a cycle every 3 weeks. Subjects assigned to group A will receive YH0618 granules twice a day (6 g each time), 6 days a week, mixed with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle. Secondary outcomes include changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion This research is of great significance for the treatment of cancer and improving the quality of life of cancer patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1800020107. Registered on 14 December 2018.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5594-5594
Author(s):  
V. E. Von Gruenigen ◽  
H. Frasure ◽  
N. Fusco ◽  
E. Eldermire ◽  
S. Eaton ◽  
...  

5594 Background: To compare the efficacy of pyridoxine versus placebo in the prevention of palmar-plantar erythrodysesthesia (PPE) and on quality of life (QOL) in patients treated with pegylated liposomal doxorubicin hydrochloride for ovarian, breast, or endometrial cancer. Methods: All patients received pegylated liposomal doxorubicin hydrochloride 40 mg/m2 IV q 4 weeks over 1 hour every 28 days for a maximum of 6 cycles. Patients received pyridoxine 100 mg (group A) by mouth or placebo (group B) twice daily. Nurses conducted standard PPE education for all patients. Patients with Grade 2 or 3 PPE that persisted despite dose reductions/delays were unblinded, and were given pyridoxine if taking placebo. Patients completed the Functional Assessment of Cancer Therapy (FACT) assessment tool. Analyses were conducted by group and comparisons were also made between patients who experienced grade 2/3 PPE versus grade 0/1. Chi-square or Fisher's exact test were used. Results: Thirty-four patients were enrolled with 18 randomized to group A and 16 to group B. Mean age was 64 years (SD=9.6; range 45–81 years). Five patients (group A, 3; group B, 2) were unevaluable (due to pegylated liposomal doxorubicin hydrochloride reaction during first chemotherapy cycle). Overall 15/29 (52%) patients had incidence of PPE (all grades), with 10/29 (34%) having grade 2/3 events (no grade 4 events observed). In group A, 8/15 (53%) patients had a PPE event and 7/14 (50%) in group B; p=0.857. For grade 2/3 events, there was no difference as 6/15 (40%) occurred in group A and 4/14 (29%) in group B; p=0.70. There were no differences in global or domain QOL scores between those patients with Grade 2/3 PPE versus Grade 0/1. Less than half [4/10 (40%)] of patients with Grade 2/3 PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Conclusions: As administered in this study, pyridoxine did not prevent PPE in patients treated with pegylated liposomal doxorubicin hydrochloride. Quality of life differences were not observed; however, not all patients with PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Pyridoxine is not indicated for prevention of PPE during chemotherapy. [Table: see text] [Table: see text]


2020 ◽  
Vol 14 ◽  
Author(s):  
Zhenkai Han ◽  
Tao Hong ◽  
Yuanyuan Ding ◽  
Shimeng Wang ◽  
Peng Yao

BackgroundPostherpetic neuralgia (PHN) is a form of long-lasting neuropathic pain that can severely affect patients’ quality of life. Pulsed radiofrequency (PRF) has been proven to be effective in treating PHN, but the optimal radiofrequency parameters are still not well defined. This retrospective study aimed to compare the efficacy and safety of CT-guided PRF at three different voltages for the treatment of PHN patients.MethodsThis study included 109 patients with PHN involving the thoracic dermatome who were treated in the Department of Pain Management of Shengjing Hospital, China Medical University, from January 2017 to May 2019. They were divided into three groups based on the PRF voltage used: group A (45 V), group B (55 V), and group C (65 V). The PRF therapy (voltage 45, 55, and 65 V) was performed in all patients by targeting the thoracic dorsal root ganglion. After surgery, patients were followed at 3 days, 1 month, 3 months, 6 months, and 12 months. Observation at each follow-up included basic patient characteristics, visual analog scale (VAS), 36-Item Short Form Health Survey (SF-36) scores, patient satisfaction, complications, and side effects.ResultsVisual analog scale scores decreased and SF-36 scores increased for all patients in the three groups at each post-operative time point (1, 3, 6, and 12 months; all P < 0.01). Pain relief, improvement in quality of life, and overall satisfaction were more significant for patients in group C than for those in groups A and B at the 3-, 6-, and 12-month follow-ups (all P < 0.05). Patients in group B had lower VAS scores and higher overall satisfaction levels than those in group A (both P < 0.01). A small number of patients from each group (n ≤ 3) experienced mild intraoperative and post-operative complications, which bore no relationship with group assignment (all P > 0.05). At post-operative day 3, patients in group C had skin numbness affecting a larger area than patients in the other two groups (both P < 0.05), but the differences were no longer statistically significant at day 30 after the operation. All patients experienced a drop in numbness area of more than 30% after surgery.ConclusionCompared with PFR at 45 and 55 V, PFR at 65 V had superior efficacy in treating PNH, with a favorable safety profile.


2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  

Abstract Background: Hair loss is the one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies have shown that YH0618 medicinal and edible decoction could significantly promote hair growth in cancer patients after chemotherapy, and will not interfere with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believe “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 200 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome end point is successful hair preservation assessed using WHO Toxicity Grading Scale (grade ≤II), and objective indexes of hair loss levels, hair density and quality recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include assessment of quality life, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial Registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107. Keywords: Medicinal and edible compound prescription, YH0618 granule, chemotherapy-induced hair loss, Taxanes, Anthracyclines, Kidney deficiency and renal dysfunction, Quality of life.


2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.


2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.


2021 ◽  
Vol 18 (1) ◽  
pp. 28-32
Author(s):  
Shashank Sangoli

Aim: Sciatica is one of the most severe form of low back pain, with a lifetime prevalence of approximately 30 percent. To assess the short-term and long-term efficacy of surgical and conservative care in the incidence of sciatic symptoms and quality of life in standard clinical settings in patients with lumbar disc herniation. Material and method: It is a retrospective study conducted at Medical Trust Hospital, Kochi who underwent micro lumbar discectomy for single level lumbar disc herniation, and of those with the same diagnosis but who refused surgery or were still waiting for the surgery to be scheduled. The patients were divided into two groups as Group A- treated surgically and Group B – awaiting for surgery and managed non-surgically. Cases between 20-60 years of age, male or female, with low back pain and lower limb radiculopathy, positive signs of root tension (SLRT between 30-70 degrees or severe femoral root stress), associated neurological dysfunction (with respect to corresponding abnormal reflexes, reduced sensation in dermatomal distribution or weakness in myotomal distribution) and multiple disc herniation cases if only one of the level was symptomatic, were included. The study excluded patients with scoliosis of more than 15 degrees, segmental instability, spondylolisthesis, spine or tumor infection, psychiatric disease, refusal of patients and age < 20 and > 60 years.  All patients recruited had to fill the consent and a clinical evaluation by means of established questionnaires which included the Short Form 36 (SF36), 16 the Oswestry Disability Index (ODI), 17 and the visual analog scale for pain (VAS). Then were grouped into: Group A, for those who had already undergone surgical treatment and Group B, those awaiting surgery. Results:Total 60 patients fulfilling the inclusion criteria were included in present study. Mean age of the patients in Group A was 36.7 ± 5.8 and in Group B was 37.01 ± 5.56 years. Male preponderance was observed in our study with male to female ratio of 1.7:1. At the time of admission, patients in both the groups suffered similar scale of pain and agony. The VAS and ODI did not show significant difference in the pain and disability in both group of patients. During follow-up of 6month and 2 years, surgically treated patients showed a significant improvement in the scores of VAS and ODI. Also the SF-36 also showed a similar results and was better in patients treated by surgery contrary with conservative treatment. Conclusion:the study concluded with positive benefits from surgery with a reduction in pain reported in the lower limbs (VAS leg with p<0.05) and improved function (Oswestry with p<0.05); however, it did not show any much significant change in quality of life according to the SF-36 scale.  


Lupus ◽  
2020 ◽  
pp. 096120332097903
Author(s):  
Francesco Natalucci ◽  
Fulvia Ceccarelli ◽  
Enrica Cipriano ◽  
Carlo Perricone ◽  
Giulio Olivieri ◽  
...  

Introduction Joint involvement represents the major determinant in quality of life (QoL)in Systemic Lupus Erhytematosus (SLE) patients. However, QoLhas been generally evaluated by non-specific questionnaires. We evaluated the relationship between SLE musculoskeletal manifestations and QoL, assessed by LupusQoL. Methods Patients with joint involvement (group A) were compared with those without this feature (group B). Disease activity was assessed by SLEDAI-2k in the whole population, while DAS28 and swollen to tender ratio were applied to assess joint activity. LupusQoL was administered to all the patients. Results Group A included 110 patients [M/F 8/102; median age 49 years (IQR 13), median disease duration 156 months (IQR 216)], group B 58 [M/F 11/47; median age 40 years (IQR 15), median disease duration 84 months (IQR 108)].We found significanlty lower values in all the LupusQoL domains except for one (burden to others) in group A in comparison with group B. A significant correlation between DAS28 values and all the LupusQoL domains in group A was found; only three domains correlated with SLEDAI-2k. Conclusions SLE-related joint involvement significantly influences disease-specific QoL. DAS28 better correlated with LupusQoL domains in comparison with SLEDAI-2k, confirming the need for specific musculoskeletal activity indices.


2021 ◽  
Vol 15 (7) ◽  
pp. 1801-1803
Author(s):  
Nazia Sajjad ◽  
Sara Qadir ◽  
Rukhsana Kasi ◽  
Tayyaba Rasheed ◽  
Fozia Unar ◽  
...  

Objectives: To compare the frequency of satisfactory quality of life between vaginal hysterectomy and abdominal hysterectomy. Study Design: Randomized controlled trial. Place and Duration of Study: Department of Obstetrics and Gynecology, Niazi Medical & Dental College, Sargodha from 1st April 2020 to 31st December 2020. Methodology: Ninety patients were comprised and they were divided in two groups; group A (vaginal hysterectomy) and Group B (abdominal hysterectomy) were performed. Hysterectomies (vaginal or abdominal) were performed by consultant gynecologist having experience at having least 5 years). Results: Mean age of the patients was 49.82±3.207 years, mean age of the patients of group A was 49.82±3.193 years and mean age of the patients of group B was 49.82±3.256 years. Satisfactory quality of life was noted in 38 (84.44%) patients of study group A and 29 (64.44%) patients of study group B. Statistically significant (P = 0.051) difference between the frequency of satisfactory quality of life between the both groups was noted. Conclusion: Results of this study reveals that post hysterectomy quality of life found more satisfactory in vaginal hysterectomy group as compared to abdominal hysterectomy group. Insignificant association of post hysterectomy quality of life with age group, marital status, parity and socio-economical status was found. Findings of this study also revealed that post hysterectomy satisfactory quality of life is not associated with education of the patients. Key words: Hysterectomy, Quality of life, abdomen, vagina, WHO, Uterus


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