scholarly journals Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial

2016 ◽  
Vol 96 (9) ◽  
pp. 1408-1416 ◽  
Author(s):  
Paolo Pillastrini ◽  
Fernanda de Lima e Sá Resende ◽  
Federico Banchelli ◽  
Anna Burioli ◽  
Emanuele Di Ciaccio ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Patient Adherence ◽  
Reference Group ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Care Providers ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background Global postural re-education (GPR) has shown positive results for patients with musculoskeletal disorders, but no previous randomized controlled trial (RCT) has investigated its effectiveness as the sole procedure for adult patients with chronic nonspecific neck pain (NP). Objective The purpose of this study was to evaluate the effectiveness of applying GPR compared with a manual therapy (MT) intervention to patients with chronic nonspecific NP. Design An RCT was conducted. Patients Ninety-four patients with chronic nonspecific NP (72 women and 22 men; average age=47.5 years, SD=11.3) were randomly assigned to receive either a GPR intervention or an MT intervention. Outcome Measures Pain intensity (visual analog scale), disability (Neck Disability Index), cervical range of motion, and kinesiophobia (Tampa Scale of Kinesiophobia) were assessed. Methods The experimental group received GPR, and the reference group received MT. Both groups received nine 60-minute-long sessions with one-to-one supervision from physical therapists as the care providers. All participants were asked to follow ergonomic advice and to perform home exercises. Measures were assessed before treatment, following treatment, and at a 6-month follow-up. Results No important baseline differences were found between groups. The experimental group exhibited a statistically significant reduction in pain following treatment and in disability 6 months after the intervention compared with the reference group. Limitations Randomization did not lead to completely homogeneous groups. It also was noted that the time spent integrating the movements practiced during the session into daily routines at the end of each session was requested only of participants in the GPR group and may have had an impact on patient adherence that contributed to a better outcome. Conclusions The results suggest that GPR was more effective than MT for reducing pain after treatment and for reducing disability at 6-month follow-up in patients with chronic nonspecific NP.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

Efficacy And Central Mechanism of Acupuncture Treatment In Patients With Neck Pain: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Zhen Gao ◽  
Tao Yin ◽  
Lei Lan ◽  
Dehua Li ◽  
Ruirui Sun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Acupuncture Treatment ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Pressure Pain Threshold ◽  
Central Mechanism ◽  
Cerebral Activity ◽  
Randomized Controlled

Abstract Background: Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating NP. This study aims to investigate the potential central mechanism of acupuncture treatment for NP by functional magnetic resonance imaging (fMRI). Methods: This is a randomized controlled trial, 86 patients will be randomly assigned into two acupuncture treatment groups at a ratio of 1:1. The whole study period includes 2 weeks baseline, 2 weeks treatments and 12 weeks follow-up (4 and 12 weeks after treatment). The pain severity, the neck disability index, the cervical range of motion, the pressure pain threshold, etc. will be used to evaluate clinical efficacy of two acupuncture prescriptions for NP treatment. The MRI scans will be performed to detect cerebral activity changes of 20 patients in each group. The clinical data and MRI data will be analysed, respectively. Pearson correlation coefficient will be used to evaluate the association between changes of cerebral activity features and improvement of clinical symptoms.Discussion: The results might provide further evidence for the clinical application of acupuncture in the treatment of NP.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000040930. Registered on December 16, 2020.

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pablo Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient’s status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care. Trial registration ClinicalTrials.gov NCT04263974. Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

scholarly journals Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial

2020 ◽  
Vol 28 (1) ◽  
Author(s):  
Claire Lagoutaris ◽  
Justin Sullivan ◽  
Michelle Hancock ◽  
Andrew M. Leaver
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cervical Spine ◽  
Neck Pain ◽  
Controlled Trial ◽  
Trial Registration ◽  
Single Treatment ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Study design Pilot randomized controlled trial. Background Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. Methods Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. Results Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. Conclusions Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. Trial registration Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis. A randomized controlled trial protocol.

2020 ◽  
Author(s):  
Pablo for the Management of Health Research of Seville F Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA) related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods: The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programmes, self-management and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion: This study will evaluate the effectiveness of a telerehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient´s status, and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.

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

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 ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

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.

scholarly journals Efficacy and central mechanism of acupuncture treatment in patients with neck pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhen Gao ◽  
Tao Yin ◽  
Lei Lan ◽  
Dehua Li ◽  
Ruirui Sun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Acupuncture Treatment ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Pressure Pain Threshold ◽  
Central Mechanism ◽  
Cerebral Activity ◽  
Randomized Controlled

Abstract Background Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating NP, this study aims to investigate the potential central mechanism of acupuncture treatment for NP by functional magnetic resonance imaging (fMRI). Methods This is a randomized controlled trial; 86 patients will be randomly assigned into two acupuncture treatment groups at a ratio of 1:1. The whole study period includes 2 weeks baseline, 2 weeks treatments, and 12 weeks follow-up (4 and 12 weeks after treatment). The pain severity, the neck disability index, the cervical range of motion, and the pressure pain threshold, etc., will be used to evaluate the clinical efficacy of two acupuncture prescriptions for NP treatment. The MRI scans will be performed to detect cerebral activity changes of 20 patients in each group. The clinical data and MRI data will be analyzed, respectively. Pearson correlation coefficient will be used to evaluate the association between changes of cerebral activity features and improvement of clinical symptoms. Discussion The results will provide further evidence for the clinical application of acupuncture in the treatment of NP. Trial registration Chinese Clinical Trial Registry ChiCTR2000040930. Registered on 16 December 2020.

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

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 ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

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 effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

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