Comparative Effectiveness of Pediatric Integrative Medicine: A Pragmatic Cluster-Controlled Trial

Symptoms of pain, nausea/vomiting, and anxiety (PNVA) are highly prevalent in pediatric inpatients. Poorly managed symptoms can lead to decreased compliance with care, and prolonged recovery times. Pharmacotherapy used to manage PNVA symptoms is of variable effectiveness and carries safety risks. Complementary therapies to manage these symptoms are gaining popularity due to their perceived benefits and low risk of harm. Pediatric integrative medicine (PIM) is the combination of complementary therapies with conventional medicine in pediatric populations. A two-arm, cluster-controlled, pragmatic clinical trial was carried out to compare the effectiveness of a PIM service in conjunction with usual care, versus usual care only to treat PNVA symptoms in hospitalized pediatric patients. The primary outcome was the improvement of PNVA symptom severity using a 10-point numerical rating scale. Participant enrollment occurred between January 2013 and January 2016. A total of 872 participants (usual care n = 497; PIM n = 375) were enrolled. The PIM therapies significantly reduced PNVA symptom severity (p < 0.001). This study found that a hospital-based PIM service is both safe and effective for alleviating PNVA symptoms. Future research should carry out this work in other pediatric inpatient divisions, and in other sites to determine the reproducibility of findings.

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Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2018-214469 ◽

2019 ◽

Vol 78 (4) ◽

pp. 465-472 ◽

Cited By ~ 15

Author(s):

Sarah Hewlett ◽

Celia Almeida ◽

Nicholas Ambler ◽

Peter S Blair ◽

Ernest H Choy ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Intention To Treat ◽

Cognitive Behavioural ◽

Numerical Rating ◽

Randomised Controlled ◽

Group Programme

ObjectivesTo see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.MethodsMulticentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.Results308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).ConclusionMultiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.Trial registration numberISRCTN52709998.

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Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial

BMC Pulmonary Medicine ◽

10.1186/s12890-021-01432-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Wei Deng ◽

Xiao-min Hou ◽

Xu-yan Zhou ◽

Qing-he Zhou

Keyword(s):

Rating Scale ◽

Numerical Rating Scale ◽

Thoracoscopic Surgery ◽

Controlled Trial ◽

Ultrasound Guided ◽

Video Assisted ◽

Prospective Randomized Controlled Trial ◽

Numerical Rating ◽

Intercostal Block ◽

Video Assisted Thoracoscopic Surgery

Abstract Background Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultrasound-guided RIB block and RISS block after video-assisted thoracoscopic surgery. Methods Ninety patients aged between 18 and 80 years, with American Society of Anesthesiologists physical status Classes I–II and scheduled for elective unilateral VATS were randomly allocated into three groups. In group C, no block intervention was performed. Patients in group RIB received ultrasound-guided RIB with 20-mL 0.375% ropivacaine and those in group RISS received ultrasound-guided RIB and serratus plane block using a total of 40-mL 0.375% ropivacaine. All patients received intravenous sufentanil patient-controlled analgesia upon arrival in the recovery room. Postoperative sufentanil consumption and pain scores were compared among the groups. Results The dosages of sufentanil consumption at 24 h after the surgery in the RIB and RISS groups were significantly lower than that in group C (p < 0.001 and p < 0.001 for all comparisons, respectively), the postoperative Numerical Rating Scale (NRS) scores in the RIB and RISS groups at 0.5, 1, 3, 6, 12, 18, and 24 h after surgery when patients were at rest or active were significantly lower than that in group C (p < 0.05 for all comparisons). The required dosage of sufentanil and time to first postoperative analgesic request in groupRISS were less than those in the group RIB at 24 h after the surgery (p < 0.001 and p < 0.001 for all comparisons, respectively). Similarly, the Numerical Rating Scale scores for group RISS at 12, 18, and 24 h after the surgery when the patients were active were significantly lower than those for group RIB (p < 0.05 for all comparisons). Conclusion Both ultrasound-guided RIB block and RISS block can effectively reduce the demand for sufentanil within 24 h after VATS, and less sufentanil dosage is needed in patient with RISS block. Ultrasound-guided RIB block and RISS block can effectively relieve pain within 24 h after VATS, and RISS block is more effective.

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Evaluation of pain management in medical transfer of trauma patients by air

CJEM ◽

10.1017/cem.2019.394 ◽

2019 ◽

Vol 21 (6) ◽

pp. 776-783

Author(s):

Isabelle H. Miles ◽

Russell D. MacDonald ◽

Sean W. Moore ◽

James Ducharme ◽

Christian Vaillancourt

Keyword(s):

Pain Management ◽

Adverse Events ◽

Rating Scale ◽

Numerical Rating Scale ◽

Trauma Centre ◽

Air Transport ◽

Future Research ◽

Trauma Patients ◽

Numerical Rating ◽

Standard Deviation Range

ABSTRACTObjectivesWith regionalized trauma care, medical transport times can be prolonged, requiring paramedics to manage patient care and symptoms. Our objective was to evaluate pain management during air transport of trauma patients.MethodsWe conducted a 12-month review of electronic paramedic records from a provincial critical care transport agency. Patients were included if they were ≥18 years old and underwent air transport to a trauma centre, and excluded if they were Glasgow Coma Scale score <14, intubated, or accompanied by a physician or nurse. Demographics, injury description, and transportation parameters were recorded. Outcomes included pain assessment via 11-point numerical rating scale, patterns of analgesia administration, and analgesia-related adverse events. Results were reported as mean ± standard deviation, [range], (percentage).ResultsWe included 372 patients: 47.0 years old; 262 males; 361 blunt injuries. Transport duration was 82.4 ± 46.3 minutes. In 232 (62.4%) patients who received analgesia, baseline numerical rating scale was 5.9 ± 2.5. Fentanyl was most commonly administered at 44.3 [25–60] mcg. Numerical rating scale after first analgesia dose decreased by 1.1 [-2–7]. Thereafter, 171 (73.7%) patients received 2.4 [1-18] additional doses. While 44 (23.4%) patients had no change in numerical rating scale after first analgesia dose, subsequent doses resulted in no change in numerical rating scale in over 65% of patients. There were 43 adverse events recorded, with nausea the most commonly reported (39.5%).ConclusionsInitial and subsequent dose(s) of analgesic had minimal effect on pain as assessed via numerical rating scale, likely due in part to inadequate dosing. Future research is required to determine and address the barriers to proper analgesia.

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The Development of the Mymop Pictorial Version

Acupuncture in Medicine ◽

10.1136/aim.22.2.68 ◽

2004 ◽

Vol 22 (2) ◽

pp. 68-71 ◽

Cited By ~ 3

Author(s):

Anthony Day

Keyword(s):

Quality Of Life ◽

Complementary Therapies ◽

Rating Scale ◽

Numerical Rating Scale ◽

Life Instrument ◽

Numerical Rating

The MYMOP is a well accepted quality of life instrument that is particularly suitable for assessing the effect of complementary therapies; however, some groups of patients find it difficult to use. A pictorial version was developed using faces instead of the numerical rating scale – it is called MYMOP pictorial. This version appears to be more acceptable to patients but has not been formally validated.

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The association of pain and stiffness with fatigue in incident polymyalgia rheumatica: baseline results from the polymyalgia rheumatica cohort study

Primary Health Care Research & Development ◽

10.1017/s1463423619000082 ◽

2019 ◽

Vol 20 ◽

Author(s):

J.A. Prior ◽

S. Muller ◽

T. Helliwell ◽

S.L. Hider ◽

K. Barraclough ◽

...

Keyword(s):

General Practice ◽

Cohort Study ◽

Polymyalgia Rheumatica ◽

Symptom Severity ◽

Rating Scale ◽

Numerical Rating Scale ◽

Newly Diagnosed ◽

Fatigue Score ◽

Numerical Rating ◽

The Mean

AbstractWe aimed to examine the association between pain, stiffness and fatigue in newly diagnosed polymyalgia rheumatica (PMR) patients using baseline data from a prospective cohort study. Fatigue is a known, but often ignored symptom of PMR. Newly diagnosed PMR patients were recruited from general practice and mailed a baseline questionnaire. This included a numerical rating scale for pain and stiffness severity, manikins identifying locations of pain and stiffness and the FACIT-Fatigue questionnaire. A total of 652 PMR patients responded (88.5%). The mean age of responders was 72.6 years (SD 9.0) and the majority were female (62.0%). Manikin data demonstrated that bilateral shoulder and hip pain and stiffness were common. The mean fatigue score (FACIT) was 33.9 (SD 12.4). Adjusted regression analysis demonstrated that a higher number of pain sites (23–44 sites) and higher pain and stiffness severity were associated with greater levels of fatigue. In newly diagnosed PMR patients, fatigue was associated with PMR symptom severity.

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Longitudinal clusters of pain and stiffness in polymyalgia rheumatica: 2-year results from the PMR Cohort Study

Rheumatology ◽

10.1093/rheumatology/kez533 ◽

2019 ◽

Vol 59 (8) ◽

pp. 1906-1915

Author(s):

Sara Muller ◽

Rebecca Whittle ◽

Samantha L Hider ◽

John Belcher ◽

Toby Helliwell ◽

...

Keyword(s):

Latent Class ◽

Rating Scale ◽

Numerical Rating Scale ◽

Postal Questionnaire ◽

The Other ◽

Future Research ◽

Partial Recovery ◽

Numerical Rating ◽

Sustained Recovery ◽

Over Time

Abstract Objectives To investigate potential subgroups of primary care–diagnosed patients with PMR based on self-reported pain and stiffness severity over time. Methods A total of 652 people with an incident PMR diagnosis were recruited from English general practices and completed a baseline postal questionnaire. They were followed up with a further six questionnaires over a 2 year period. A total of 446 people completed the 2 year follow-up. Pain and stiffness were reported on a 0–10 numerical rating scale. Latent class growth analysis was used to estimate the joint trajectories of pain and stiffness over time. A combination of statistical and clinical considerations was used to choose the number of clusters. Characteristics of the classes were described. Results Five clusters were identified. One cluster represented the profile of ‘classical’ PMR symptoms and one represented sustained symptoms that may not be PMR. The other three clusters displayed a partial recovery, a recovery followed by worsening and a slow, but sustained recovery. Those displaying classical PMR symptoms were in better overall health at diagnosis than the other groups. Conclusion PMR is a heterogeneous condition, with a number of phenotypes. The spectrum of presentation, as well as varying responses to treatment, may be related to underlying health status at diagnosis. Future research should seek to stratify patients at diagnosis to identify those likely to have a poor recovery and in need of an alternative treatment pathway. Clinicians should be aware of the different experiences of patients and monitor symptoms closely, even where there is initial improvement.

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Laughter and Stress Relief in Cancer Patients: A Pilot Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/864739 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 5

Author(s):

S. H. Kim ◽

Y. H. Kim ◽

H. J. Kim

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Alternative Therapy ◽

Control Group ◽

Breast Cancer Patients ◽

Numerical Rating ◽

Anxiety Depression

The purpose of this study was to examine the effect of a therapeutic laughter program and the number of program sessions on anxiety, depression, and stress in breast cancer patients. A randomized controlled trial was conducted involving 31 patients who received four sessions of therapeutic laughter program comprised and 29 who were assigned to the no-program control group. Scores for anxiety, depression, and stress were measured using an 11-point numerical rating scale. While no change was detected in the control group, the program group reported reductions of 1.94, 1.84, and 2.06 points for anxiety, depression, and stress, respectively (p<0.01,p<0.01, andp<0.01). Scores decreased significantly after the first therapeutic laughter session (p<0.05,p<0.01, andp<0.01). As the therapeutic laughter program was effective after only a single session in reducing anxiety, depression, and stress in breast cancer patients, it could be recommended as a first-line complementary/alternative therapy.

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The efficacy of acupuncture as a complementary treatment for pain and anxiety after breast cancer surgery: Study protocol for a pragmatic randomized control trial

F1000Research ◽

10.12688/f1000research.27805.2 ◽

2020 ◽

Vol 9 ◽

pp. 1440

Author(s):

Cristina López de San Román-Fernández ◽

Carles Fernández-Jané ◽

Maite Cusidó ◽

Lluís Costa-Tutusaus

Keyword(s):

Breast Cancer ◽

Adverse Effects ◽

Standard Care ◽

Rating Scale ◽

Numerical Rating Scale ◽

Low Cost ◽

Controlled Trial ◽

Breast Cancer Surgery ◽

Medical Procedure ◽

Numerical Rating

Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy. Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications. Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects. Trial registration: ClinicalTrials.gov NCT04608175 29/10/2020

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Acupuncture for Cancer Related Pain: Protocol for a Pragmatic Randomised Wait-List Controlled Trial

Integrative Cancer Therapies ◽

10.1177/1534735420976579 ◽

2020 ◽

Vol 19 ◽

pp. 153473542097657

Author(s):

Qi Zhao ◽

Suyang Zheng ◽

Geoff P. Delaney ◽

Eugene Moylan ◽

Meera R. Agar ◽

...

Keyword(s):

Adverse Events ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Post Treatment ◽

Local Health ◽

Wait List ◽

Clinical Trial Registry ◽

Numerical Rating ◽

Randomised Controlled

Background: Acupuncture has been proved effective for cancer related pain (CRP) in China, America and some other countries. However, there is relative lack of evidence to support the use of acupuncture for CRP in Australia. Objectives: To assess the effectiveness and safety of acupuncture for management of CRP in a real-world setting and to understand cancer patients’ experience of undergoing acupuncture for CRP. Methods: A pragmatic randomised controlled trial will be conducted in South Western Sydney Local Health District (SWSLHD) in NSW, Australia. Adults with cancer related pain (n = 106) will be randomised in a 1:1 ratio to receive the acupuncture intervention up front versus after a wait list period of 4 weeks. Pain level (by Numerical Rating Scale), analgesic use, auricular acupressure frequency and adverse events will be assessed at baseline, mid-treatment and post-treatment. Expectancy on trial outcome (by Credibility and Expectancy questionnaire) will be assessed at baseline. The perspective of the participants (by an interview) will be recorded after the last intervention. Expected outcomes: We hypothesise that acupuncture will relieve cancer related pain at mid-treatment and post-treatment. We also hypothesise that few adverse events will be provoked by acupuncture. Trial registration: Australia New-Zealand Clinical Trial Registry (ACTRN12620000325909).

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