Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

Effects of daily mindfulness practice on fatigue, kinesiophobia, and quality of life in patients with acute myocardial infarction: a randomized controlled trial

European Heart Journal Acute Cardiovascular Care ◽

10.1093/ehjacc/zuab020.138 ◽

2021 ◽

Vol 10 (Supplement_1) ◽

Author(s):

C Karadas ◽

M Oksul ◽

N Ozer ◽

L Ozdemir

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Mindfulness Practice ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Quality Of Life Scale ◽

Tampa Scale For Kinesiophobia

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim Mindfulness meditation (MM) leads to controlled blood pressure and positive improvements in other symptoms which may trigger acute coronary diseases. The present randomized controlled study was aimed to investigate the effect of the MM on fatigue, kinesiophobia, and the quality of life (QoL) in patients with acute MI. Method The study was carried out with 56 MI patients. Participants were randomly assigned to meditation group (MG; n = 28) or control group (CG; n = 28). The MG patients received a 15 min MM session comprising sitting and breathing for a total of eight weeks, while the CG patients received only a single-time attention-matched education. Piper Fatigue Intervention, Tampa Scale for Kinesiophobia-Heart and MacNew Quality of Life scales were utilized for data collection. Results After completion of the 8-week MM, any significant difference was not found in the fatigue scores of the patients (p > 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p < 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p < 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p < 0.05). Conclusion The MM can significantly improve the QoL and decrease kinesiophobia in patients with MI. Beneficial effect of MM is maintained particularly in the emotional aspect. Based on the results of the study, MM may be recommended as a mind-body based complementary approaches within the scope of secondary protection after MI. Comparison of the study groupsGroupBaseline(Mean ± SD)4th week(Mean ± SD)8th week(Mean ± SD)12th week(Mean ± SD)PFSMM2.08 ± 1.870.90 ± 0.990.47 ± 0.780.44 ± 0.76CG1.56 ± 2.011.12 ± 1.590.98 ± 1.520.76 ± 1.33tp1.004 0.32-0.6210.54-1.5840.12-1.0850.28TSK-HMM40.25 ± 5.0436.18 ± 4.4934.39 ± 4.6134.96 ± 4.71CG41.71 ± 7.2841.89 ± 6.7441.82 ± 5.8441.00 ± 5.54tp-0.8750.39-3.7340.001-5.279 0.000-4.3900.00MacNewMM5.04 ± 0.715.53 ± 0.455.76 ± 0.475.77 ± 0.47CG5.17 ± 0.855.32 ± 0.605.37 ± 0.525.53 ± 0.46t; p-0.640; 0.531.436; 0.162.933; 0.0051.964; 0.06(Mean ± SD): Mean ± Standard Deviation; PFS: Piper Fatigue Scores; TSK-H: Tampa Scale for Kinesiophobia-Heart; MacNew: MacNew Quality of life Scale; EFS: emotional functioning sub-dimension; PFS: physical functioning sub-dimension; SFS: social functioning sub-dimension; t= Student T Test value; p< 0.05

Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7974816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Mastour Saeed Alshahrani ◽

Jaya Shanker Tedla ◽

Ravi Shankar Reddy ◽

Faisal Asiri

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Disability ◽

Sf 36 ◽

Neck Disability ◽

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

The Effect of Educational Program on Pain Management, Self-Efficacy Behavior, and Quality of Life among Adult Diabetic Patients with Peripheral Neuropathy Pain: A Randomized Controlled Trial

Experimental and Clinical Endocrinology & Diabetes ◽

10.1055/a-1561-8392 ◽

2021 ◽

Author(s):

Jawad Ahmad Abu-Shennar ◽

Nurhan Bayraktar

Keyword(s):

Quality Of Life ◽

Pain Management ◽

Educational Intervention ◽

Self Efficacy ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group ◽

Diabetic Care

Abstract Objective Jordan has a high prevalence of painful diabetic peripheral neuropathy (PDPN), leg complications, and amputations due to diabetes. This study evaluated the effect of educational programs on pain management, self-efficacy behaviors, and quality of life (QoL) among adult patients with PDPN. Methods The randomized controlled trial study was conducted at the Jordanian Ministry of Health hospitals between October 2019 – March 2020. Seventy-two adult patients with PDPN were randomized to an experimental group of 36 patients who attended an educational program and a control group who followed routine diabetic care in the study setting. The data were collected using a socio-demographic and diabetes clinical/laboratory data form, the numeric rating scale (NRS), diabetes self-efficacy scale (DSES), and the quality-of-life questionnaire (EQ-5D). The intervention program consisted of four educational sessions at weekly intervals. Pre-test and post-test evaluations were conducted. Results After the educational intervention, the mean scores of the NRS (p=0.020), DSES (p<0.001), and EQ-5D (p<0.001) in the experimental group improved significantly improved compared to those in the control group. Additionally, while there were no significant correlations between the three study outcomes in the pre-test stage, correlations were observed to be significant after the educational intervention. Conclusion This study shows that the design and implementation of educational intervention combined with routine diabetic care facilitate effective pain management, self-efficacy behaviors, and QoL of patients with PDPN. The health care providers are recommended to use the educational programs for such patients at various levels of services in both health centers and diabetes clinics.

Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

10.21203/rs.3.rs-16509/v3 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v2 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Effects of the introduction of objective criteria for referral and discharge in physical therapy for ischemic stroke in China: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519896014 ◽

2019 ◽

Vol 34 (3) ◽

pp. 345-356

Author(s):

Nan Xia ◽

Jan D Reinhardt ◽

Shouguo Liu ◽

Juanjuan Fu ◽

Caili Ren ◽

...

Keyword(s):

Quality Of Life ◽

Motor Function ◽

Controlled Trial ◽

Teaching Hospitals ◽

Controlled Study ◽

Control Group ◽

Tier 2 ◽

Randomized Controlled ◽

Tier 3

Objective: To examine the effectiveness of a set of rules for referral and therapy input in a three-tiered physiotherapy program on activities of daily living (ADL), motor function, and quality of life of stroke survivors. Design: Randomized controlled study. Setting: Rehabilitation departments of 11 teaching hospitals. Subjects: A total of 285 participants with stroke. Outcome measures: Primary outcome was ADL independence measured with the Modified Barthel Index (MBI) at weeks 3, 6, 9, 13, and 17. Secondary outcomes were motor function and quality of life measured with Fugel-Meyer Assessment (FMA) and Stroke-Specific Quality-of-Life (SSQOL) scale. Intervention: Two complementary sets of rules governing rehabilitation delivery were introduced: a set of criteria that determined when someone ought to move from tier 1 onto tier 2, and from tier 2 onto tier 3, and a second set of rules that determined the amount and type of physiotherapy input given in each tier. Control group participants received conventional rehabilitation without any specified guidelines. Results: With a difference of 3.97 (95% confidence interval (CI): 1.59–6.36), MBI increased stronger in the study group than in controls between baseline and week 3 ( P = 0.001). This difference could be sustained until study end-point. No significant differences were found for FMA. Differences in increase of SSQOL were higher in the intervention than control at week 9 ( P < 0.05). Conclusion: Introduction of a set of rules for referral and therapy input at different stages of rehabilitation partially improved patients’ ADL and quality of life, but did not improve motor function.

Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/1705964 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Yu-Wei Chang ◽

Tsia-Shu Lo ◽

Hsin-Ning Chang ◽

Yi-Hsien Shiao ◽

Yuan-Chieh Yeh

Keyword(s):

Quality Of Life ◽

Overactive Bladder ◽

Controlled Trial ◽

Laser Acupuncture ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

Individualized Diet and Lifestyle Modifications Reverse Symptoms of Systemic Lupus Erythematosus (Preprint)

10.2196/preprints.11804 ◽

2018 ◽

Author(s):

Daniel Rothman ◽

Faiz Khan ◽

Vanessa Rudin

Keyword(s):

Quality Of Life ◽

Effect Size ◽

Controlled Trial ◽

Health Coaching ◽

Control Group ◽

Sustained Remission ◽

Randomized Controlled ◽

BACKGROUND There is increasing evidence that digital therapeutic tools can bring personalized medicine to the masses improving outcomes and decreasing cost. Many factors influence the expression of autoimmune disease, and understanding and removing these underlying triggers provides an opportunity to minimize use of medications and some patients can achieve sustained remission if the right triggers for a patient are identified. This randomized controlled trial is the first to test the efficacy of a digital therapeutic intervention which combines adaptive patient generated health data tracking with health coaching to identify factors triggering lupus and to evaluate reductions in symptoms, and improvements in quality of life. OBJECTIVE Evaluate impact of personalized dietary and environmental interventions on quality of life and health care costs. METHODS This a randomized controlled trial using a convenience sample. The Mann-Whitney U test determined that a sample size of 40 patients (20 intervention and 20 control) provides a power of 80% for continuous and ordinal variables. The Bonferroni Correction was used to ensure that the probability of a type 1 error is less than 5% even with the large number of hypotheses being tested. Subjects in both groups received standard of care from their physicians. All subjects repeated the online questionnaires (Fatigue Scale - FACIT, Lupus QOL, and BPI-SF) at weeks 4, 8, 12, and 16. The experimental group going through the mymee protocol received health coaching (weekly calls to educate and implement changes based on data analysis). Digital data collection and tracking was used to correlate dietary/lifestyle/environmental patterns with symptoms. The control group completed the same assessments during the 16 week intervention period but did not receive any additional coaching. The intervention uses correlations between symptoms and triggers that are reported daily to create an iterative cycle of hypotheses tailored to each individual. With 5 min of tracking a day using the app, patients easily report what they have eaten, other triggers, and their symptoms. Using our machine learning platform, coaches identify each patient’s personal disease triggers and help patients implement changes to remove them. RESULTS The interim results of the study showed that 78% improved in the experimental group and 36% in the control group with a P<.01. Furthermore, 67% of the patients have gone off some or all of their drugs after consulting with their doctors. CONCLUSIONS Results show a significant improvement for lupus patients who completed the protocol, demonstrating the potential for digital therapeutics to dramatically improve the quality of life for patients diagnosed not only with lupus, but other chronic diseases (80% of the trial patients also had rheumatoid arthritis). Broad adoption of the mymee intervention could assist in building a database of lupus triggers and symptoms that could lead to further understanding the causes of lupus. Based on interim results, a 78/36 effect size is competitive if not more effective than current drugs in the pipeline like Stelara which shows a 60/31 effect size and includes potential side effects of drug-induced MS and cancer.

Effects Of Virtual Reality Associated With Serious Games For Upper Limb Rehabilitation In Patients With Multiple Sclerosis: A Randomized Controlled Trial

10.21203/rs.3.rs-16509/v1 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.