Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study

ObjectivesTo test the feasibility of using a new activity pacing framework to standardise healthcare professionals’ instructions of pacing, and explore whether measures of activity pacing/symptoms detected changes following treatment.DesignSingle-arm, repeated measures study.SettingOne National Health Service (NHS) Pain Service in Northern England, UK.ParticipantsAdult patients with chronic pain/fatigue, including chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis.InterventionsSix-week rehabilitation programme, standardised using the activity pacing framework.Outcome measuresFeasibility was explored via patients’ recruitment/attrition rates, adherence and satisfaction, and healthcare professionals’ fidelity. Questionnaire data were collected from patients at the start and end of the programme (T1 and T2, respectively) and 3 months’ follow-up (T3). Questionnaires included measures of activity pacing, current/usual pain, physical/mental fatigue, depression, anxiety, self-efficacy, avoidance, physical/mental function and quality of life. Mean changes in activity pacing and symptoms between T1-T2, T2-T3 and T1-T3 were estimated.ResultsOf the 139 eligible patients, 107 patients consented (recruitment rate=77%); 65 patients completed T2 (T1-T2 attrition rate=39%), and 52 patients completed T3 (T1-T3 attrition rate=51%). At T2, patients’ satisfaction ratings averaged 9/10, and 89% attended ≥5 rehabilitation programme sessions. Activity pacing and all symptoms improved between T1 and T2, with smaller improvements maintained at T3.ConclusionThe activity pacing framework was feasible to implement and patients’ ability to pace and manage their symptoms improved. Future work will employ a suitable comparison group and test the framework across wider settings to explore the effects of activity pacing in a randomised controlled trial.Trial registration numberNCT03497585.

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Dental arch effects after early and later timed cervical headgear treatment—a randomized controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjy083 ◽

2019 ◽

Vol 41 (6) ◽

pp. 622-630

Author(s):

Johanna Julku ◽

Matti Hannula ◽

Kirsi Pirilä-Parkkinen ◽

Mimmi Tolvanen ◽

Pertti Pirttiniemi

Keyword(s):

Repeated Measures ◽

Controlled Trial ◽

Class Ii ◽

Dental Arch ◽

Maxillary Molars ◽

Parallel Group ◽

Repeated Measures Analysis ◽

Size Groups ◽

T1 And T2

Summary Background Cervical headgear (CH) is a commonly used orthodontic appliance and its dentoalveolar changes are known. However, the effects related to gender and timing have gained less attention. Objectives To examine dimensions of dental arches among children with Class II occlusion without posterior mandibular rotation according to timing of Kloehn-type CH treatment. Trial design Prospective, randomized, parallel-group controlled trial. Methods Sixty-seven seven-year-old children with a Class II occlusion were included in the study. The children were randomized into two equal-size groups in 1:1 ratio by sealed-envelope randomization. The early group (EG, n = 33) was treated between T0 and T1 (26 months), right after eruption of the first maxillary molars. The late group (LG, n = 34) was treated between T1 and T2 (24 months). The children were treated with CH until normal Class I occlusion on first molars was achieved. Impressions for dental casts were taken from all participants at T0, T1, and T2. Blinding was applicable for outcome assessors. Changes in dental cast measurements were compared between the groups and genders using t-test, Mann-Whitney U-test, and repeated measures analysis of variance. Results Of the children, 56 completed the study. The maxillary arch length and the transversal changes between the upper canines and upper first molars were significantly increased in EG at T0−T1 (P < 0.001). At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males. No harms were encountered. Conclusions The male gender benefits most from early timing of the CH treatment, showing larger dimensions at the end of the follow-up. The results clearly indicated a wider and longer upper dental arch and spontaneous expansion of the lower dental arch after treatment. Clinical Registration NCT02010346.

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The online delivery of exercise oncology classes supported with health coaching: A pilot randomized controlled trial

10.1101/2021.11.29.21266169 ◽

2021 ◽

Author(s):

Maximilian Eisele ◽

Rosemary Twomey ◽

Andrew J. Pohl ◽

Meghan H. McDonough ◽

Margaret L. McNeely ◽

...

Keyword(s):

Controlled Trial ◽

Primary Objective ◽

Recruitment Rate ◽

Health Coaching ◽

Attrition Rate ◽

Structured Interviews ◽

Online Delivery ◽

Supervised Exercise ◽

Exercise Oncology ◽

Synchronous Online

Purpose: The primary objective was to investigate the feasibility of a synchronous, online delivered, group-based, supervised, exercise oncology maintenance program supported with health coaching. Methods: All participants had previously completed a 12-week group-based exercise study. In the current study, participants were randomized to a 12-week exercise oncology maintenance class with or without health coaching. The primary outcome was feasibility, assessed as intervention attendance, safety and fidelity, study recruitment, attrition and outcome assessment completion. Additionally, semi-structured interviews at the end of the intervention provided participants' perspectives on intervention feasibility. Results: Forty participants (n8WK=25; n12WK=15) enrolled in the study. Feasibility was confirmed for recruitment rate (42.6%), attrition rate (2.5%), safety (no adverse events), health coaching attendance (97%), health coaching fidelity (96.7%), class attendance (91.2%), class fidelity (92.6%), and assessment completion (questionnaire=98.8%; physical functioning=97.5%). Based on the qualitative feedback, feasibility was facilitated by the convenience, while the diminished ability to connect with other participants online was a drawback compared to in-person delivery. Conclusion: The synchronous online delivery of an exercise oncology maintenance class, the additional health coaching support, and the tools used to measure the intervention effectiveness were feasible for individuals living with and beyond cancer. Keywords health coaching, exercise, physical activity, maintenance, cancer survivors, online-delivery, mHealth

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Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0512 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Shubhamoy Ghosh ◽

Rai Khushboo Ravindra ◽

Amila Modak ◽

Shukdeb Maiti ◽

Arunava Nath ◽

...

Keyword(s):

Repeated Measures ◽

Rating Scales ◽

Controlled Trial ◽

Attrition Rate ◽

Effect Sizes ◽

Secondary Outcome ◽

Systematic Research ◽

Controlled Clinical Trial ◽

Serious Adverse Events ◽

Double Blind

Abstract Objectives Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. Methods A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat (ITT) sample. Results Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. Conclusions Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.

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The influence of a telehealth project on healthcare professional recruitment and retention in remote areas in Mali: A longitudinal study

SAGE Open Medicine ◽

10.1177/2050312116648047 ◽

2016 ◽

Vol 4 ◽

pp. 205031211664804 ◽

Cited By ~ 3

Author(s):

Gisèle Irène Claudine Mbemba ◽

Cheick Oumar Bagayoko ◽

Marie-Pierre Gagnon ◽

Louise Hamelin-Brabant ◽

David A Simonyan

Keyword(s):

Healthcare Professional ◽

Repeated Measures ◽

Healthcare Professionals ◽

Positive Influence ◽

Rank Test ◽

District Health ◽

Recruitment And Retention ◽

Independent Variables ◽

T1 And T2 ◽

The Impact

Objectives: The telehealth project EQUI-ResHuS (in French, Les TIC pour un accès Équitable aux Ressources Humaines en Santé) aimed to contribute to more equitable access to care and support practice in remote regions in Mali. This study explored the evolution of perceptions concerning telehealth among healthcare professionals in the four district health centres that participated in the EQUI-ResHus project and identified variables influencing their perceptions of telehealth impact on recruitment and retention of health professionals. Methods: One year after a first survey (T1), a second data collection (T2) was carried out among healthcare professionals using a 91-item questionnaire. Questions assessing telehealth use and perceptions and perceived impact on recruitment and retention of healthcare professionals were rated on a 5-point Likert scale. A total of 10 independent variables were considered for the analyses. A Wilcoxon signed-rank test was performed to detect differences between T1 and T2, and a bivariate linear regression model for repeated measures was carried out to assess the impact of independent variables on dependent variables. Results: There were no noticeable changes in perceptions related to telehealth influence on recruitment and retention. Only access to information and communication technology significantly differed between T1 and T2 according the Wilcoxon rank test (p = 0.001). Perceived influence of telehealth on recruitment and retention was mostly explained by attitude towards telehealth, perceived effect on recruitment and retention and barriers to recruitment and retention. Conclusion: Based on our results, telehealth was perceived as having a positive influence but mostly indirect influence on healthcare professional recruitment and retention. Also, there were no major changes after 1 year of telehealth use.

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Is it time to ACT? A qualitative study of the acceptability and feasibility of Acceptance and Commitment Therapy for adolescents with Chronic Fatigue Syndrome

10.1101/2021.04.20.21255804 ◽

2021 ◽

Author(s):

Philippa Clery ◽

Jennifer Starbuck ◽

Amanda Laffan ◽

Roxanne Parslow ◽

Catherine Linney ◽

...

Keyword(s):

Acceptance And Commitment Therapy ◽

Healthcare Professionals ◽

Controlled Trial ◽

Alternative Therapy ◽

Chronic Fatigue ◽

List Type ◽

Fatigue Syndrome ◽

Acceptance And Commitment ◽

One Year ◽

Randomised Controlled

Abstract Background Paediatric Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is disabling and relatively common. Although evidenced based treatments are available, at least 15% of children remain symptomatic after one year of treatment. Acceptance and Commitment Therapy (ACT) is an alternative therapy option; however, little is known about whether it is an acceptable treatment approach. Our aim was to find out if children who are still disabled by CFS/ME after 12 months of treatment would find ACT acceptable, to inform a randomised controlled trial (RCT) of ACT. Methods We recruited children (diagnosed with CFS/ME; not recovered after one year of treatment; aged 11-17 years), their parent/carer, and healthcare professionals (HCPs) from one specialist UK paediatric CFS/ME service. We conducted semi-structured interviews to explore barriers to recovery; views on current treatments; acceptability of ACT; and feasibility of using an RCT to test effectiveness. Thematic analysis was used to identify patterns in data. Results Twelve adolescents, eleven parents, and seven HCPs were interviewed. All participants thought ACT was acceptable. Participants identified reasons why ACT might be efficacious: pragmatism, acceptance and compassion are valued in chronic illness; values-focussed treatment provides motivation and direction; psychological and physical needs are addressed; normalising difficulties is a useful life-skill. Some adolescents preferred ACT to Cognitive Behavioural Therapy as it encouraged accepting (rather than challenging) thoughts. Most adolescents would consent to an RCT of ACT but a barrier to recruitment was reluctance to randomisation. All HCPs deemed ACT feasible to deliver. Some were concerned patients might confuse ‘acceptance’ with ‘giving up’ and called for clear explanations. All participants thought the timing of ACT should be individualised. Conclusions All adolescents with CFS/ME, parents, and HCPs thought ACT was acceptable, and most adolescents were willing to try ACT. An RCT needs to solve issues around randomisation and timing of the intervention. BOX What is known about the subject? Not all young people with CFS/ME recover. ACT is a possible alternative therapy for CFS/ME, which focuses on improving functioning and quality of life rather than symptom reduction. ACT is efficacious in paediatric chronic pain, and preliminary results show promising effects in adults with CFS/ME. What this study adds? ACT is an acceptable therapy for young people with CFS/ME. Participants thought the ‘pragmatic’, ‘compassionate’ and ‘values-based’ focus of ACT would be helpful. Adolescents, parents and healthcare professionals support a randomised controlled trial of ACT.

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A simplified 10-step Tai-chi programme to enable people with dementia to improve their motor performance: a feasibility study

Clinical Rehabilitation ◽

10.1177/0269215518786530 ◽

2018 ◽

Vol 32 (12) ◽

pp. 1609-1623 ◽

Cited By ~ 1

Author(s):

Justina Yat Wa Liu ◽

Rick Yiu Cho Kwan ◽

Claudia KY Lai ◽

Keith D Hill

Keyword(s):

Family Caregivers ◽

Motor Performance ◽

Tai Chi ◽

Controlled Trial ◽

Training Programme ◽

Recruitment Rate ◽

Attrition Rate ◽

Control Group ◽

Feasibility Assessment ◽

People With Dementia

Objective: To evaluate the feasibility and preliminary effects of a simplified 10-step Tai-chi programme to improve the motor performance of people with dementia. Design: A two-arm, single-blinded cluster randomized controlled trial, registered with ClinicalTrials.gov (NCT03341091). Setting: Community health centres. Participants: Twenty-six dyads of people with dementia and their family caregivers were recruited, with mean (SD) ages of 82.2 (7.43) and 51.3 (18.97), respectively. Interventions: The experimental group underwent a 16 week 10-step simplified Tai-chi training programme, with additional measures to enhance engagement. The control group joined recreational activities organized by the centres. Main outcome measure(s): The feasibility assessment included recruitment, attrition, adherence to, and engagement in the Tai-chi programme. The preliminary effects were assessed by the participants’ performance in mobility tests. Results: Preliminary feasibility was established, with an acceptable recruitment rate of 58% (26 out of 45 assessed dyads) and a high attendance rate of 81% (25.88 out of 32 Tai-chi sessions). There was positive engagement in the training sessions, and no adverse incidents. However, five participants withdrew from the Tai-chi group, for a high attrition rate of 38%, and the mean home practice time decreased between weeks 8 and 16. In most of the motor performance tests, a slight but insignificant improvement was observed in the Tai-chi group compared to the control group. Conclusion: A tailored Tai-chi programme for people with dementia using a dyadic approach has been found to be feasible. However, stronger support must be provided to family caregivers to improve the participants’ sustained participation.

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Effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a protocol for a feasibility randomised controlled trial (the Otago MASTER trial)

BMJ Open ◽

10.1136/bmjopen-2018-028261 ◽

2019 ◽

Vol 9 (7) ◽

pp. e028261

Author(s):

Daniel C Ribeiro ◽

Zohreh Jafarian Tangrood ◽

Gisela Sole ◽

J Haxby Abbott

Keyword(s):

Randomised Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Recruitment Rate ◽

Rehabilitation Programme ◽

Drop Out ◽

Feasibility Trial ◽

Intervention Effects ◽

Mixed Model Analysis ◽

Randomised Controlled

IntroductionExercise therapy is the treatment of choice for the management of patients with shoulder subacromial pain. However, we do not know whether a tailored rehabilitation programme is more effective than a standardised strengthening programme. The aim of this feasibility trial is to assess: (1) participant recruitment rate, (2) the proportion of participants enrolled from the total number screened, (3) adherence to the rehabilitation programme, (4) drop-out rates, (5) obtain estimates of adverse reactions to treatment, (6) obtain estimates of intervention effects in order to inform the sample size of the fully-powered randomised controlled trial, (7) conduct a preliminary cost-effectiveness analysis of the standardised strengthening and the tailored rehabilitation interventions.MethodsThe MAnagement of Subacromial disorders of The shouldER (MASTER) trial, is a two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. Participants will be randomly allocated into one of the interventions group: tailored or standardised rehabilitation. To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. To determine whether it is feasible to conduct the full trial, we will consider 75% CI as the probability threshold at 3-month follow-up.Ethics and disseminationThis study was approved by the University of Otago Ethics Committee (Ref: H17/080). Findings from this study will be presented at national and international conferences, and will be submitted for publication in a peer-reviewed journal.Trial registration numberANZCTR: 12617001405303

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