scholarly journals VIRTUAL REALITY THERAPY IN THE TREATMENT OF HAM/TSP INDIVIDUALS: RADOMIZED CLINICAL TRIAL

2014 ◽  
Vol 4 (2) ◽  
Author(s):  
Victor Almeida Cardoso de Oliveira Arnau ◽  
Maíra Macêdo ◽  
Elen Beatriz Pinto ◽  
Abrahão Fontes Baptista ◽  
Bernardo Galvão Castro-Filho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Virtual Reality ◽  
Positive Impact ◽  
Therapeutic Option ◽  
Spastic Paraparesis ◽  
Double Blind ◽  
Therapeutic Exercises ◽  
Emotional Aspects

Introdution: The myelopathy associated with HTLV-1 or tropical spastic paraparesis (HAM/TSP) is a chronic, progressive demyelination disease that predominantly affects the spinal cord. The balance and locomotion in affected individuals are compromised and require therapeutic alternatives for rehabilitation. Objective: To determine the effect on aspects of balance, pain and quality of life for the use of virtual reality as an additional therapeutic option in the treatment of patients with HAM / TSP. Methodology: Randomized double blind clinical trial was conducted with nine individuals with the diagnosis confirmed by WHO criteria, divided into a group that performed a protocol of therapeutic exercises and another added that the exercise protocol, four games to virtual reality. All participants underwent an evaluation of the balance by Berg scale, of pain by visual analogical scale (VAS) and quality of life by SF-36 before and after 10 sessions. Results: The group that performed exercises with virtual therapy showed improvements in balance (p=0.033), functional capacity (p=0.010) and emotional aspects (p=0.004) in the intragroup analysis and the emotional aspects on intergroup analysis (p=0.027). Conclusion: Virtual reality did not reduce pain intensity but demonstrated a positive impact on the emotional aspects of quality of life.

Oral Propolis, Nutritional Status and Quality of Life with Chemotherapy for Breast Cancer: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 1-9
Author(s):  
Seyed Hossein Davoodi ◽  
Vahid Yousefinejad ◽  
Bayazid Ghaderi ◽  
Mohammad Esmail Akbari ◽  
Shoaleh Darvishi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Nutritional Status ◽  
Double Blind ◽  
Double Blind Clinical Trial

scholarly journals A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025526
Author(s):  
Xiaofang Lv ◽  
Rui Feng ◽  
Jingbo Zhai
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Growth Factor ◽  
Fibroblast Growth Factor ◽  
Treatment Period ◽  
Current Evidence ◽  
Fibroblast Growth ◽  
Acidic Fibroblast Growth Factor ◽  
Double Blind

IntroductionNipple fissure and nipple pain are common complaints among breastfeeding mothers. Studies found that mupirocin was effective in preventing and treating infections of damaged nipple and nipple pain. Acidic fibroblast growth factor (aFGF) plays an important role in wound healing. However, current evidence on the efficacy and safety of mupirocin plus aFGF for nipple fissure and nipple pain in breastfeeding women is inconclusive due to the lack of well-designed randomised controlled trials on this topic. The purpose of this study is to test the hypothesis that mupirocin plus aFGF is more effective than mupirocin alone for nipple fissure and nipple pain in breastfeeding women.Methods and analysisThis study is a randomised, double-blind, single-centre, parallel-group clinical trial. A total of 120 breastfeeding women with nipple fissure and nipple pain will be randomly assigned to either mupirocin plus aFGF group or mupirocin plus placebo group according to a computer-generated random allocation sequence. The treatment period lasts 14 days. The primary outcome is nipple pain intensity measured by the Visual Analogue Scale on day 14 during the treatment period. Secondary outcome measures include time to complete nipple pain relief, changes in the Nipple Trauma Score, time to complete healing of nipple trauma, quality of life measured by the Maternal Postpartum Quality of Life (MAPP-QOL) Questionnaire, the frequency of breast feeding, the rate of breastfeeding discontinuation, weight change in infants and adverse events.Ethics and disseminationThe study has gained approval from the Ethics Review Committee of Tianjin Central Hospital of Gynaecology Obstetrics on 22 January 2018 (approval no. 2018KY001). We plan to publish our research findings in a peer-reviewed academic journal and disseminate these findings in international conferences. This study has been registered with the Chinese Clinical Trial Registry.Trial registration numberChiCTR1800017248.

scholarly journals Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Function, and Quality of Life in Fibromyalgia: A Double-Blind Randomized Clinical Trial

2015 ◽  
Vol 95 (1) ◽  
pp. 129-140 ◽  
Author(s):  
Brian Noehren ◽  
Dana L. Dailey ◽  
Barbara A. Rakel ◽  
Carol G.T. Vance ◽  
Miriam B. Zimmerman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Nerve Stimulation ◽  
Transcutaneous Electrical Nerve Stimulation ◽  
Treatment Modalities ◽  
Double Blind ◽  
Electrical Nerve Stimulation ◽  
Double Blind Placebo ◽  
Patient Reported

BackgroundFibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.ObjectivesThe purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.DesignThis will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.ParticipantsThree hundred forty-three participants with fibromyalgia will be recruited for this study.InterventionParticipants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.MeasurementsThe primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.LimitationsBecause having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.ConclusionsThe results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.

Changes in oral health related quality of life after dental bleaching in a double-blind randomized clinical trial

2014 ◽  
Vol 42 (2) ◽  
pp. 114-121 ◽  
Author(s):  
Sônia Saeger Meireles ◽  
Marília Leão Goettems ◽  
Raquel Venâncio Fernandes Dantas ◽  
Álvaro Della Bona ◽  
Iná S. Santos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Randomized Clinical Trial ◽  
Health Related Quality ◽  
Double Blind ◽  
Dental Bleaching ◽  
Related Quality ◽  
Health Related

scholarly journals Personal innovative approach in radiation therapy of lung cancer- functional lung avoidance SPECT-guided (ASPECT) radiation therapy: a study protocol for phase II randomised double-blind clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Azza Ahmed Khalil ◽  
Eric Hau ◽  
Val Gebski ◽  
Cai Grau ◽  
Harriet Gee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Radiation Dose ◽  
Pulmonary Toxicity ◽  
Double Blind ◽  
Curative Intent ◽  
Radiation Induced

Abstract Background Radiation therapy (RT) plays a key role in curative-intent treatment for locally advanced lung cancer. Radiation induced pulmonary toxicity can be significant for some patients and becomes a limiting factor for radiation dose, suitability for treatment, as well as post treatment quality of life and suitability for the newly introduced adjuvant immunotherapy. Modern RT techniques aim to minimise the radiation dose to the lungs, without accounting for regional distribution of lung function. Many lung cancer patients have significant regional differences in pulmonary function due to smoking and chronic lung co-morbidity. Even though reduction of dose to functional lung has shown to be feasible, the method of preferential functional lung avoidance has not been investigated in a randomised clinical trial. Methods In this study, single photon emission computed tomography (SPECT/CT) imaging technique is used for functional lung definition, in conjunction with advanced radiation dose delivery method in randomised, double-blind trial. The study aims to assess the impact of functional lung avoidance technique on pulmonary toxicity and quality of life in patients receiving chemo-RT for lung cancer. Eligibility criteria are biopsy verified lung cancer, scheduled to receive (chemo)-RT with curative intent. Every patient will undergo a pre-treatment perfusion SPECT/CT to identify functional lung. At radiation dose planning, two plans will be produced for all patients on trial. Standard reference plan, without the use of SPECT imaging data, and functional avoidance plan, will be optimised to reduce the dose to functional lung within the predefined constraints. Both plans will be clinically approved. Patients will then be randomised in a 2:1 ratio to be treated according to either the functional avoidance or the standard plan. This study aims to accrue a total of 200 patients within 3 years. The primary endpoint is symptomatic radiation-induced lung toxicity, measured serially 1–12 months after RT. Secondary endpoints include: a quality of life and patient reported lung symptoms assessment, overall survival, progression-free survival, and loco-regional disease control. Discussion ASPECT trial will investigate functional avoidance method of radiation delivery in clinical practice, and will establish toxicity outcomes for patients with lung cancer undergoing curative chemo-RT. Trial registration Clinicaltrials.gov Identifier: NCT04676828. Registered 1 December 2020.

scholarly journals Effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Hair Loss ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Group A ◽  
Group B

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.

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