scholarly journals Effects of Manual Therapy on Fatigue, Pain, and Psychological Aspects in Women with Fibromyalgia

Author(s):  
Yolanda Nadal-Nicolás ◽  
Jacobo Ángel Rubio-Arias ◽  
María Martínez-Olcina ◽  
Cristina Reche-García ◽  
María Hernández-García ◽  
...  

Fibromyalgia is a condition characterised by chronic widespread muscle pain and fatigue, sleep disturbances, cognitive disorders, and mood disturbance. The purpose of this study was to determine the effectiveness of a manual therapy technique performed with moderate digital pressure in women with fibromyalgia (n = 24). In this randomised, controlled trial, the participants were randomly assigned to the experimental group or placebo group. The experimental group was assisted with manual therapy sessions based on connective tissue massage, whereas the placebo group was “treated” with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo. Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29) were completed before and after the intervention. In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia (p < 0.001). Correlations showed a relationship between fatigue and sleep variables (R = 0.411; p = 0.046) and pain variables with the POMS anger-hostility subscale (R = 0.436; p = 0.033). Although the size of the sample could be a limitation, the study concluded that the application of manual therapy in fibromyalgia patients performed with moderate pressure for 15 min on the posterior cervical musculature decreased the perception of pain, muscle fatigue, and the state of tension-anxiety.

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kristina Traxler ◽  
Franz Schinabeck ◽  
Eva Baum ◽  
Edith Klotz ◽  
Barbara Seebacher

Abstract Background Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. Methods This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Discussion Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. Trial registration German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.


2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.


Author(s):  
Chris Papadopoulos ◽  
Nina Castro ◽  
Abiha Nigath ◽  
Rosemary Davidson ◽  
Nicholas Faulkes ◽  
...  

AbstractThis trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.


1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).


2020 ◽  
Author(s):  
Kristina Traxler ◽  
Franz Schinabeck ◽  
Eva Baum ◽  
Edith Klotz ◽  
Barbara Seebacher

Abstract Background: Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT and the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke.Methods: This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-minute talocrural joint MT plus 30-minute specific TOT (Group A); 45-minute specific TOT (Group B); controls (Group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty ulilising predefined progression criteria. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-minute concurrent x4 weekly homebased training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life.Discussion: Results from this study will inform a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. We hope that the study findings help to enhance stroke rehabilitation.Trial registration: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.


PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.


2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.


2021 ◽  
Author(s):  
Qing-Juan Wu ◽  
Wen-Liang Lv ◽  
Juan-Mei Li ◽  
Ting-Ting Zhang ◽  
Wen-Hui Zhou ◽  
...  

Abstract Introduction: Hepatitis B-related compensated liver cirrhosis is related to higher risk of hepatocellular carcinoma, anti-viral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aim to test the integrative medicine (chinese medicine plus anti-riral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis B-related compensated liver cirrhosis.Methods and Analysis: This is a multicentre randomised controlled trial, total 5 hospitals and 802 patients will involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction(YQSHD) group (n=401) or the placebo group (n=401). The YQSHD group receives YQSHD granule with Entecavir(ETV), the placebo group receives YQSHD placebo with ETV. Treatment period will last for 52 weeks, and follow-up period for 52±2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. Objective of this trial is “the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%”.Ethics and dissemination:The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China (No.2019-006-KY), and the other centres in the trial will not begin recruiting until local ethical approval has been obtained.Trial final results will be disseminated via publication. Trial registration: ChiCTR1900021532, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn/searchproj.aspx) on February 26th, 2019.


2021 ◽  
Vol 9 (9) ◽  
pp. 1933
Author(s):  
Esther Jiménez ◽  
Susana Manzano ◽  
Dietmar Schlembach ◽  
Krzysztof Arciszewski ◽  
Rocio Martin ◽  
...  

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.


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