scholarly journals Effectiveness of pediatric integrative manual therapy in cervical movement limitation in infants with positional plagiocephaly: a randomized controlled trial

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
César Hidalgo-García ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Control Group ◽  
Positional Plagiocephaly ◽  
Therapy Approach ◽  
Caregiver Education ◽  
Randomized Controlled ◽  
Neuromotor Development

Abstract Background Positional plagiocephaly (PP) is a cranial deformation frequent amongst children and consisting in a flattened and asymmetrical head shape. PP is associated with excessive time in supine and with congenital muscular torticollis (CMT). Few studies have evaluated the efficiency of a manual therapy approach in PP. The purpose of this parallel randomized controlled trial is to compare the effectiveness of adding a manual therapy approach to a caregiver education program focusing on active rotation range of motion (AROM) and neuromotor development in a PP pediatric sample. Methods Thirty-four children with PP and less than 28 week-old were randomly distributed into two groups. AROM and neuromotor development with Alberta Infant Motor Scale (AIMS) were measured. The evaluation was performed by an examiner, blinded to the randomization of the subjects. A pediatric integrative manual therapy (PIMT) group received 10-sessions involving manual therapy and a caregiver education program. Manual therapy was addressed to the upper cervical spine to mobilize the occiput, atlas and axis. The caregiver educational program consisted in exercises to reduce the positional preference and to stimulate motor development. The control group received the caregiver education program exclusively. To compare intervention effectiveness across the groups, improvement indexes of AROM and AIMS were calculated using the difference of the final measurement values minus the baseline measurement values. If the distribution was normal, the improvement indexes were compared using the Student t-test for independent samples; if not, the Mann-Whitney U test was used. The effect size of the interventions was calculated using Cohen’s d. Results All randomized subjects were analysed. After the intervention, the PIMT group showed a significantly higher increase in rotation (29.68 ± 18.41°) than the control group (6.13 ± 17.69°) (p = 0.001). Both groups improved the neuromotor development but no statistically significant differences were found. No harm was reported during the study. Conclusion The PIMT intervention program was more effective in increasing AROM than using only a caregiver education program. The study has been retrospectively registered at clinicaltrials.gov, with identification number NCT03659032. Registration date: September 1, 2018.

scholarly journals Efficacy of Pediatric Integrative Manual Therapy In Cervical Movement Limitation In Infants With Positional Plagiocephaly: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
Cesar Hidalgo García ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Control Group ◽  
Positional Plagiocephaly ◽  
Therapy Approach ◽  
Caregiver Education ◽  
Randomized Controlled ◽  
Neuromotor Development

Abstract Background: Positional plagiocephaly (PP) is a cranial deformation frequent amongst children and consisting in a flattened and asymmetrical head shape. PP is associated with excessive time in supine and with congenital muscular torticollis (CMT). Few studies have evaluated the efficiency of a manual therapy approach in PP. The purpose of this parallel randomized controlled trial is to compare the effectiveness of adding a manual therapy approach to a caregiver education program focusing on active rotation range of motion (AROM) and neuromotor development in a PP pediatric sample. Methods: 34 children with PP and less than 28 week old were randomly distributed into two groups. AROM and neuromotor development with Alberta Infant Motor Scale (AIMS) were measured. The evaluation was performed by an examiner, blinded to the randomization of the subjects. A pediatric integrative manual therapy (PIMT) group received 10-sessions involving manual therapy and a caregiver education program. The control group received the caregiver education program exclusively. To compare intervention effectiveness across the groups, improvement indexes of AROM and AIMS were calculated using the difference of the final measurement values minus the baseline measurement values. If the distribution was normal, the improvement indexes were compared using the Student t-test for independent samples; if not, the Mann-Whitney U test was used. The effect size of the interventions was calculated using Cohen's d. Results: All randomized subject were analysed. After the intervention, the PIMT group showed a significantly higher increase in rotation (29.68 ± 18.41º) than the control group (6.13 ± 17.69º) (p< 0.05). Both groups improved the neuromotor development but no statistical significant differences were found. No harm was reported during the study.Conclusion: The PIMT intervention program was more effective in increasing AROM than using only a caregiver education program.

scholarly journals Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
Ángel Luis Rodríguez-Fernández ◽  
...  
Keyword(s):  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Asymmetry Index ◽  
Trial Registration ◽  
Control Group ◽  
Parental Perception ◽  
Positional Plagiocephaly ◽  
Caregiver Education ◽  
Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

scholarly journals Touch, Caring, and Cancer: randomized controlled trial of a multimedia caregiver education program

2012 ◽  
Vol 21 (5) ◽  
pp. 1405-1414 ◽  
Author(s):  
William Collinge ◽  
Janet Kahn ◽  
Tracy Walton ◽  
Leila Kozak ◽  
Susan Bauer-Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Education Program ◽  
Controlled Trial ◽  
Caregiver Education ◽  
Randomized Controlled

scholarly journals An Online Pain Education Program for Working Adults: Pilot Randomized Controlled Trial

10.2196/15071 ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. e15071 ◽  
Author(s):  
Yajie Li ◽  
Mun Yee Mimi Tse
Keyword(s):  
Randomized Controlled Trial ◽  
Education Program ◽  
Self Efficacy ◽  
Educational Program ◽  
Controlled Trial ◽  
Control Group ◽  
Pain Education ◽  
Working Adults ◽  
Randomized Controlled ◽  
Experimental Group

Background Pain is a common public health concern, and the pain situation among the general population is serious in mainland China. Working adults commonly experience pain because of long sitting times, a lack of free time, and exercise. A lack of pain-related knowledge is also a significant factor. Educational and therapeutic programs delivered online were used more often in Western countries, and accessible programs in China are limited, especially for pain management. Therefore, we carried out an online pain education program for working adults to self-manage pain. The program was delivered through WeChat, a popular and secure social media with a large population base in China. Objective This study aimed to (1) provide pain-related knowledge and self-relief strategies, (2) help participants reduce pain and improve pain-related emotional well-being, and (3) explore participants’ learning performance and the acceptability of the online pain education program. Methods This was a randomized controlled trial. Chinese adults aged between 16 and 60 years with full-time employment, with pain in the past 6 months, and without any mental illness were recruited using snowball sampling through the internet and were randomly allocated to an experimental group and a control group in 1:1 ratio after the baseline assessment. The 4-week educational program that included basic knowledge of pain, pharmacological and nonpharmacological treatments, and related resources was provided only to the experimental group. Outcomes of pain, depression, anxiety, stress, and pain self-efficacy were measured at baseline (T0), posttreatment (T1), and 1-month follow-up (T2). Participants’ acceptability and satisfaction were explored after completing the educational program. Results In total, 95 eligible participants joined in the program: 47 in the experimental group and 48 in the control group. Neck and shoulder, head, and back were most commonly reported pain sites with high pain scores. Pain intensity and interference of the experimental group were significantly reduced after the educational program. Depression, anxiety, and stress clinically improved and pain self-efficacy improved after the educational program. The difference in depression, anxiety, stress, and pain self-efficacy within a group or between groups was not statistically significant; however, clinical improvements were demonstrated. A significant correlation between dosage of the intervention and pain intensity and depression was demonstrated. After completing the educational program, more than half of the participants showed acceptance of and satisfaction with the program, and they were willing to recommend the program to others. Conclusions Our findings highlight the significant potential of this online education program in the treatment of pain. Trial Registration ClinicalTrials.gov NCT03952910; https://clinicaltrials.gov/ct2/show/NCT03952910

scholarly journals An Online Pain Education Program for Working Adults: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Yajie Li ◽  
Mun Yee Mimi Tse
Keyword(s):  
Randomized Controlled Trial ◽  
Education Program ◽  
Self Efficacy ◽  
Educational Program ◽  
Controlled Trial ◽  
Control Group ◽  
Pain Education ◽  
Working Adults ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Pain is a common public health concern, and the pain situation among the general population is serious in mainland China. Working adults commonly experience pain because of long sitting times, a lack of free time, and exercise. A lack of pain-related knowledge is also a significant factor. Educational and therapeutic programs delivered online were used more often in Western countries, and accessible programs in China are limited, especially for pain management. Therefore, we carried out an online pain education program for working adults to self-manage pain. The program was delivered through WeChat, a popular and secure social media with a large population base in China. OBJECTIVE This study aimed to (1) provide pain-related knowledge and self-relief strategies, (2) help participants reduce pain and improve pain-related emotional well-being, and (3) explore participants’ learning performance and the acceptability of the online pain education program. METHODS This was a randomized controlled trial. Chinese adults aged between 16 and 60 years with full-time employment, with pain in the past 6 months, and without any mental illness were recruited using snowball sampling through the internet and were randomly allocated to an experimental group and a control group in 1:1 ratio after the baseline assessment. The 4-week educational program that included basic knowledge of pain, pharmacological and nonpharmacological treatments, and related resources was provided only to the experimental group. Outcomes of pain, depression, anxiety, stress, and pain self-efficacy were measured at baseline (T0), posttreatment (T1), and 1-month follow-up (T2). Participants’ acceptability and satisfaction were explored after completing the educational program. RESULTS In total, 95 eligible participants joined in the program: 47 in the experimental group and 48 in the control group. Neck and shoulder, head, and back were most commonly reported pain sites with high pain scores. Pain intensity and interference of the experimental group were significantly reduced after the educational program. Depression, anxiety, and stress clinically improved and pain self-efficacy improved after the educational program. The difference in depression, anxiety, stress, and pain self-efficacy within a group or between groups was not statistically significant; however, clinical improvements were demonstrated. A significant correlation between dosage of the intervention and pain intensity and depression was demonstrated. After completing the educational program, more than half of the participants showed acceptance of and satisfaction with the program, and they were willing to recommend the program to others. CONCLUSIONS Our findings highlight the significant potential of this online education program in the treatment of pain. CLINICALTRIAL ClinicalTrials.gov NCT03952910; https://clinicaltrials.gov/ct2/show/NCT03952910

scholarly journals Efficacy of Pediatric Integrative Manual Therapy in Positional Plagiocephaly: A Randomized Controlled Trial.

2020 ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
María Orosia Lucha López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
Ángel Luis Rodríguez-Fernández ◽  
...  
Keyword(s):  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Asymmetry Index ◽  
Parental Perception ◽  
Positional Plagiocephaly ◽  
Caregiver Education ◽  
Cranial Index ◽  
Registration Number ◽  
Registration Date

Abstract Background: positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods: 34 neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (-10 cm to +10 cm). Results: CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40 % compared with 0.34 ± 1.72% in the controls (p=0.000). CI changes did not present any significant differences between the 2 groups. Manual therapy increased positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p= 0.004). Conclusion: manual therapy plus caregiver education program improved cranial symmetry and parents’ satisfaction more effectively than solely caregiver education program.Trial registration: trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.https://clinicaltrials.gov/ct2/show/NCT03659032?term=NCT03659032&cond=Plagiocephaly&draw=2&rank=1

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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