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

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.

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

10.21203/rs.3.rs-113394/v1 ◽

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

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

Italian Journal of Pediatrics ◽

10.1186/s13052-021-00995-9 ◽

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.

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

10.21203/rs.3.rs-122219/v1 ◽

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.

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THE EFFECT OF CAREGIVER EDUCATION PROGRAM ON FUNCTIONAL INDEPENDENCE AND MORTALITY IN FIRST-EVER STROKE

Malaysian Journal of Medical Research ◽

10.31674/mjmr.2018.v02i02.009 ◽

2018 ◽

Vol 2 (2) ◽

pp. 57-67

Author(s):

S.Airiza Ahmad ◽

Iman Supandiman ◽

Soemarmo Markam ◽

Riwanti Estiasari ◽

Graeme Hankey

Keyword(s):

Quality Of Life ◽

Education Program ◽

Stroke Unit ◽

Controlled Trial ◽

Stroke Survivor ◽

Functional Independence ◽

Control Group ◽

Invasive Treatment ◽

Caregiver Education

Background: At present, the management of stroke focuses not only on the acute stage of saving the penumbra but also on the secondary prevention of managing the potential sequel following stroke, preventing the occurrence of another attack, and improving the quality of life. Continuous role of caregivers in supporting stroke survivor after passing the acute phase is therefore invaluable. Caregiver education program (CEP) was routinely used as a part of discharge plan on acute stroke patients in stroke unit in Indonesia. This study aims to evaluate the effect of CEP as one of stroke rehabilitation modalities using a historical data that still correlated to the practice in stroke unit nowadays. Methods: A single-blinded randomized controlled trial was performed on 172 subjects of first-ever stroke with no other comorbidities and not having invasive treatment on the recruitment time. The subjects were randomly allocated into two groups: a group receiving CEP (n=88) as the experiment group and a control group (n=84). A four-session CEP, held since the second week of admission by interactive discussion using overhead projector and poster, was performed by a neurologist to the caregiver member of experiment group stroke survivor. The outcome of functional independence and mortality on the third month post-onset was assessed using Barthel activity daily living (ADL) index and the mortality report, respectively. Results: No statistical difference was found on the baseline of the two groups. CEP significantly increased the functional independence (RR=1.30, 95% CI 1.03-1.63) of stroke survivor. Despite the insignificant effect on three-month survival, the group receiving CEP had less mortality rate over time. Conclusion: Caregiver education program had a positive outcome on the patient’s functional independence. Thus, it improves the quality of life.

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Cochlear implantation for tinnitus in adults with bilateral hearing loss: protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-043288 ◽

2021 ◽

Vol 11 (5) ◽

pp. e043288

Author(s):

Kelly Assouly ◽

Adriana L Smit ◽

Inge Stegeman ◽

Koenraad S Rhebergen ◽

Bas van Dijk ◽

...

Keyword(s):

Hearing Loss ◽

Randomised Controlled Trial ◽

Cochlear Implantation ◽

Controlled Trial ◽

Trial Registration ◽

Secondary Outcome ◽

Control Group ◽

Auditory Input ◽

Registration Number ◽

Randomised Controlled

IntroductionTinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.Method and analysisIn this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck’s Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.Ethics and disseminationThis research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.Trial registration numberTrial registration number NL8693; Pre-results.

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Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00886-0 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Kristina Traxler ◽

Franz Schinabeck ◽

Eva Baum ◽

Edith Klotz ◽

Barbara Seebacher

Keyword(s):

Randomised Controlled Trial ◽

Ankle Joint ◽

Manual Therapy ◽

Controlled Trial ◽

Daily Activities ◽

Control Group ◽

Chronic Stage ◽

Post Stroke ◽

Randomised Controlled ◽

Task Oriented

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.

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Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-021-10627-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mariko Nishikawa ◽

Masaaki Yamanaka ◽

Akira Shibanuma ◽

Junko Kiriya ◽

Masamine Jimba

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Safety Information ◽

Intervention Group ◽

Health And Safety ◽

Trial Registration ◽

Control Group ◽

Internet Portal ◽

Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-191731 ◽

2021 ◽

pp. 1-10

Author(s):

Katrin Brück ◽

Kirsten Jacobi ◽

Tobias Schmidt

Keyword(s):

Neck Pain ◽

Manual Therapy ◽

Repeated Measures ◽

Primary Outcome ◽

Controlled Trial ◽

Severity Of Illness ◽

Chronic Neck Pain ◽

Secondary Outcome ◽

Control Group ◽

Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

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Analgesic effects of intravenous flunixin and intrafunicular lidocaine or their combination for castration of lambs

Veterinary Record Open ◽

10.1136/vetreco-2017-000266 ◽

2018 ◽

Vol 5 (1) ◽

pp. e000266 ◽

Cited By ~ 2

Author(s):

Paola Straticò ◽

Vincenzo Varasano ◽

Riccardo Suriano ◽

Massimo Mariscoli ◽

Domenico Robbe ◽

...

Keyword(s):

General Anaesthesia ◽

Controlled Trial ◽

Serum Cortisol ◽

Cortisol Concentration ◽

University Teaching ◽

Control Group ◽

Lidocaine Group ◽

Analgesic Effects ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo analyse the effectiveness of intrafunicular lidocaine and intravenous flunixin for reducing pain and signs of stress in lambs undergoing surgical castration.DesignRandomised controlled trial.SettingOne university teaching hospital in Italy.Participants30 healthy male lambs, 9–12 weeks old.InterventionAllocation to five groups: a control group (C), undergoing general anaesthesia but not castration; a surgery group (S), undergoing orchiectomy without analgesic treatment; a surgery-lidocaine group (SL), undergoing orchiectomy and receiving intrafunicular 2 per cent lidocaine solution; a surgery-flunixin group (SF), undergoing orchiectomy and receiving intravenous flunixin; a surgery-flunixin-lidocaine group (SFL), undergoing orchiectomy and receiving both intrafunicular lidocaine and intravenous flunixin.Main outcome measuresNociception and stress were assessed through intraoperative indicators, serum cortisol concentration, glycaemia, behaviour, immune response and clinical evaluation of the heart rate (HR), respiratory rate and rectal temperature after surgery.ResultsGroups S and SL showed increased values of intraoperative HR, mean arterial pressure and postoperative cortisol concentration. In group SFL, cortisol values were similar to those of group C. No other difference could be detected.ConclusionsThe combination of intravenous flunixin and intrafunicular lidocaine reduced the pain and discomfort of lambs castrated under general anaesthesia. Intrafunicular lidocaine alone did not prevent pain or discomfort associated with castration.Trial registration number30/2012/CEISA/COM.

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