scholarly journals Potential treatment effect modifiers for manipulative therapy for children complaining of spinal pain.Secondary analyses of a randomised controlled trial

2019 ◽  
Vol 27 (1) ◽  
Author(s):  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Jan Hartvigsen ◽  
Niels Wedderkopp ◽  
Lise Hestbæk
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Spinal Pain ◽  
Potential Effect ◽  
Manipulative Therapy ◽  
Randomised Controlled

Abstract Background In children, spinal pain is transitory for most, but up to 20% experience recurrent and bothersome complaints. It is generally acknowledged that interventions may be more effective for subgroups of those affected with low back pain. In this secondary analysis of data from a randomized clinical trial, we tested whether five indicators of a potential increased need for treatment might act as effect modifiers for manipulative therapy in the treatment of spinal pain in children. We hypothesized that the most severely affected children would benefit more from manipulative therapy. Method This study was a secondary analysis of data from a randomised controlled trial comparing advice, exercises and soft tissue treatment with and without the addition of manipulative therapy in 238 Danish school children aged 9–15 years complaining of spinal pain. A text message system (SMS) and clinical examinations were used for data collection (February 2012 to April 2014). Five pre-specified potential effect modifiers were explored: Number of weeks with spinal pain 6 months prior to inclusion, number of weeks with co-occurring musculoskeletal pain 6 months prior to inclusion, expectations of the clinical course, pain intensity, and quality of life. Outcomes were number of recurrences of spinal pain, number of weeks with pain, length of episodes, global perceived effect, and change in pain intensity. To explore potential effect modification, various types of regression models were used depending on the type of outcome, including interaction tests. Results We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant. Conclusions This secondary analysis indicates that children more effected by certain baseline characteristics, but not pain intensity, have a greater chance to benefit from treatment that include manipulative therapy. However, these analyses were both secondary and underpowered, and therefore merely exploratory. The results underline the need for a careful choice of inclusion criteria in future investigations of manipulative therapy in children. Trial registration NCT01504698; results 

scholarly journals Effects of electroacupuncture on anxiety and depression in unmarried patients with polycystic ovarian syndrome: secondary analysis of a pilot randomised controlled trial

2019 ◽  
Vol 37 (1) ◽  
pp. 40-46
Author(s):  
Zhi Wang ◽  
Haoxu Dong ◽  
Qing Wang ◽  
Lina Zhang ◽  
Xiaoke Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Acupuncture Group ◽  
Anxiety And Depression ◽  
Control Group ◽  
Scale Scores ◽  
Randomised Controlled

Objective: To evaluate the efficacy of electroacupuncture (EA) for the treatment of anxiety and depression in unmarried patients with polycystic ovarian syndrome (PCOS) by secondary analysis of a randomised controlled trial. Methods: A prospective pilot randomised controlled trial of unmarried women with PCOS was conducted from November 2012 to March 2016. Participants were assigned to the acupuncture group (receiving EA for 16 weeks) or the control group (receiving sham acupuncture for 16 weeks), with 27 patients in each group. The pre-specified primary outcomes and all secondary outcomes, with the exception of serum levels of neurotransmitters including norepinephrine (NE), epinephrine (AD), serotonin (5-HT) and γ-aminobutyric acid (GABA), will be reported separately. Additional outcome measures selected for this secondary analysis included anxiety and depression scale scores (Zung-SAS and Zung-SDS), 36-Item Short Form (SF-36) scale scores, PCOS Quality of Life (PCOSQOL) scale scores and Chinese Quality of Life (CHQOL) scale scores. Results: After the16-week intervention, an increase in serum NE and reduction in 5-HT were observed in the acupuncture group (P=0.028 and P=0.023, respectively). The serum level of GABA decreased in both groups after the interventions (both P<0.001). However, there were no significant differences between the two groups in the levels of any neurotransmitters (p>0.05). After EA treatment, SAS and SDS scores were decreased in the acupuncture group (P=0.007 and P=0.027, respectively) and were lower than those of the control group (P=0.003 and P=0.004, respectively). The SF-36 domain scores for mental health, vitality, social functioning, general health and health transition, the total CHQOL scores, and the infertility problems and body hair domains of the PCOSQOL improved significantly after EA (P<0.05). Conclusion: EA appears to improve symptoms of anxiety/depression and quality of life in PCOS patients and may influence serum levels of NE and 5-HT. These findings should be interpreted with caution, given the secondary nature of the outcome measures reported herein. Trial registration number: NCT01812161; ChiCTR-TRC-12002529

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

scholarly journals E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041548
Author(s):  
Cristian Ochoa-Arnedo ◽  
Joan Carles Medina ◽  
Aida Flix-Valle ◽  
Dimitra Anastasiadou
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Emotional Distress ◽  
Controlled Trial ◽  
Psychosocial Care ◽  
Cost Utility ◽  
Psychosocial Services ◽  
Randomised Controlled

IntroductionPsychosocial interventions for patients with breast cancer (BC) have demonstrated their effectiveness at reducing emotional distress and improving quality of life. The current digitisation of screening, monitoring and psychosocial treatment presents the opportunity for a revolution that could improve the quality of care and reduce its economic burden. The objectives of this study are, first, to assess the effectiveness of an e-health platform with integrated and stepped psychosocial services compared with usual psychosocial care, and second, to examine its cost–utility.Methods and analysisThis study is a multicentre randomised controlled trial with two parallel groups: E-health intervention with integrated and stepped psychosocial services vs usual psychosocial care. An estimated sample of 338 patients with BC in the acute survival phase will be recruited from three university hospitals in Catalonia (Spain) and will be randomly assigned to one of two groups. All participants will be evaluated at the beginning of the study (T1: recruitment), 3 months from T1 (T2), 6 months from T1 (T3) and 12 months from T1 (T4). Primary outcome measures will include number of clinical cases detected, waiting time from detection to psychosocial intervention and proportion of cases successfully treated in the different steps of the intervention, as well as outcomes related to emotional distress, quality of life, post-traumatic stress and growth, treatment adherence and therapeutic alliance. Secondary outcomes will include the acceptability of the platform, patients’ satisfaction and usability. For the cost–utility analysis, we will assess quality-adjusted life years and costs related to healthcare utilisation, medication use and adherence, work absenteeism and infrastructure-related and transport-related costs.Ethics and disseminationThis study was approved by the Ethics committee of the Institut Català d’Oncologia network in Hospitalet, Spain. Findings will be disseminated through peer-reviewed journals, reports to the funding body, conferences among the scientific community, workshops with patients and media press releases.Trial registration numberOnline Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors (ICOnnectat-B),NCT04372459.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035337 ◽  
Author(s):  
Joost Wolfs ◽  
Jop Beugels ◽  
Merel Kimman ◽  
Andrzej A Piatkowski de Grzymala ◽  
Esther Heuts ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Lymph Node ◽  
Randomised Controlled Trial ◽  
Conservative Treatment ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Breast Cancer Treatment ◽  
Randomised Controlled

IntroductionEarly breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.Methods and analysisA multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.Ethics and disseminationThe study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.Trial registration numberNCT02790021; Pre-results.

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