Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

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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)

10.2196/preprints.13973 ◽

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.

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The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1724465 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Caitlin E. Marks ◽

Gloria Broadwater ◽

Elliot Le ◽

Adam D. Glener ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Breast Reconstruction ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Lavender Oil ◽

Entire Cohort ◽

Randomized Controlled ◽

Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.06.12341 ◽

2021 ◽

Vol 104 (6) ◽

pp. 887-894

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Adjuvant Chemotherapy ◽

Energy Conservation ◽

Cancer Patients ◽

Controlled Trial ◽

Control Group ◽

Breast Cancer Patients ◽

Randomized Controlled ◽

Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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Testing the Effectiveness of a Strengths-Based Intervention Targeting All 24 Strengths: Results From a Randomized Controlled Trial

Psychological Reports ◽

10.1177/0033294120937441 ◽

2020 ◽

pp. 003329412093744

Author(s):

Lobna Chérif ◽

Valerie M. Wood ◽

Christian Watier

Keyword(s):

Randomized Controlled Trial ◽

Character Strengths ◽

Controlled Trial ◽

Control Group ◽

Strength Development ◽

Character Strength ◽

Significant Group ◽

Randomized Controlled ◽

Time Interaction ◽

Experimental Group

This study assessed the effectiveness of a strengths-based randomized controlled trial focused on fostering all 24 character strengths in a group of 75 participants from a University in Tunisia. Participants randomly assigned to the challenge condition (n = 40) received an email each day for 24 days, that highlighted a particular strength of the day including why the strength is valuable, how to implement the strength behaviourally, and a motto related to that strength. Those in the control condition (n = 35) simply received emails containing the motto for each strength daily for 24 days. We assessed all participants’ levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2). Results from a 2 (group) X 3 (time) split plot ANOVA revealed a significant group-by-time interaction, such that at T2 the experimental group had greater happiness scores than the control group. These findings provide some evidence that even “minimalist” interventions (involving the receipt of emails encouraging character-strength development), might be effective for promoting gains in happiness even one month after the intervention.

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Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

Palliative & Supportive Care ◽

10.1017/s1478951518000901 ◽

2019 ◽

Vol 17 (1) ◽

pp. 46-53

Author(s):

Kaori Ichihara ◽

Sayako Ouchi ◽

Sachiko Okayama ◽

Fukiko Kinoshita ◽

Mitsunori Miyashita ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Usual Care ◽

Pain Assessment ◽

Spiritual Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

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Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7974816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Mastour Saeed Alshahrani ◽

Jaya Shanker Tedla ◽

Ravi Shankar Reddy ◽

Faisal Asiri

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Disability ◽

Sf 36 ◽

Neck Disability ◽

Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

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Effects of an Interactive Computer Game Exercise Regimen on Balance Impairment in Frail Community-Dwelling Older Adults: A Randomized Controlled Trial

Physical Therapy ◽

10.2522/ptj.20090205 ◽

2011 ◽

Vol 91 (10) ◽

pp. 1449-1462 ◽

Cited By ~ 84

Author(s):

Tony Szturm ◽

Aimee L. Betker ◽

Zahra Moussavi ◽

Ankur Desai ◽

Valerie Goodman

Keyword(s):

Randomized Controlled Trial ◽

Video Game ◽

Dynamic Balance ◽

Controlled Trial ◽

Community Dwelling ◽

Control Group ◽

Day Hospital ◽

Randomized Controlled ◽

Balance Exercises ◽

Experimental Group

Background Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Design This study was a randomized controlled trial. Setting The study was conducted in a geriatric day hospital. Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study. Interventions Participants were randomly assigned to either a control group or an experimental group. The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital. The experimental group received a program of dynamic balance exercises coupled with video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2 per week, with each session lasting 45 minutes. Measurements Data for the following measures were obtained before and after treatment: Berg Balance Scale, Timed “Up & Go” Test, Activities-specific Balance Confidence Scale, modified Clinical Test of Sensory Interaction and Balance, and spatiotemporal gait variables assessed in an instrumented carpet system test. Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups, and change scores were significantly greater in the experimental group compared with the control group. No significant treatment effect was observed in either group for the Timed “Up & Go” Test or spatiotemporal gait variables. Limitations The sample size was small, and there were group differences at baseline in some performance measures. Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait function.

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A Randomized Controlled Trial of a Passive Accessory Joint Mobilization on Acute Ankle Inversion Sprains

Physical Therapy ◽

10.1093/ptj/81.4.984 ◽

2001 ◽

Vol 81 (4) ◽

pp. 984-994 ◽

Cited By ~ 144

Author(s):

Toni Green ◽

Kathryn Refshauge ◽

Jack Crosbie ◽

Roger Adams

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Step Length ◽

Control Group ◽

Joint Mobilization ◽

Randomized Controlled ◽

Ankle Inversion ◽

Before And After ◽

Experimental Group ◽

Support Time

Abstract Background and Purpose. Passive joint mobilization is commonly used by physical therapists as an intervention for acute ankle inversion sprains. A randomized controlled trial with blinded assessors was conducted to investigate the effect of a specific joint mobilization, the anteroposterior glide on the talus, on increasing pain-free dorsiflexion and 3 gait variables: stride speed (gait speed), step length, and single support time. Subjects. Forty-one subjects with acute ankle inversion sprains (<72 hours) and no other injury to the lower limb entered the trial. Methods. Subjects were randomly assigned to 1 of 2 treatment groups. The control group received a protocol of rest, ice, compression, and elevation (RICE). The experimental group received the anteroposterior mobilization, using a force that avoided incurring any increase in pain, in addition to the RICE protocol. Subjects in both groups were treated every second day for a maximum of 2 weeks or until the discharge criteria were met, and all subjects were given a home program of continued RICE application. Outcomes were measured before and after each treatment. Results. The results showed that the experimental group required fewer treatment sessions than the control group to achieve full pain-free dorsiflexion. The experimental group had greater improvement in range of movement before and after each of the first 3 treatment sessions. The experimental group also had greater increases in stride speed during the first and third treatment sessions. Discussion and Conclusion. Addition of a talocrural mobilization to the RICE protocol in the management of ankle inversion injuries necessitated fewer treatments to achieve pain-free dorsiflexion and to improve stride speed more than RICE alone. Improvement in step length symmetry and single support time was similar in both groups.

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Randomized Controlled Trial of a Cognitive Narrative Crisis Intervention for Bereavement in Primary Healthcare

Behavioural and Cognitive Psychotherapy ◽

10.1017/s1352465816000345 ◽

2016 ◽

Vol 45 (1) ◽

pp. 85-90 ◽

Cited By ~ 1

Author(s):

Ana Sofia Andrade ◽

Margarida Moreira ◽

Mónica Sá ◽

Duarte Pacheco ◽

Vera Almeida ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Traumatic Stress ◽

Controlled Trial ◽

Cost Effective ◽

Structured Interview ◽

Control Group ◽

Randomized Controlled ◽

Demographic Questionnaire ◽

The Impact ◽

Experimental Group

Background and Aims: As there are known risks of retraumatization through bereavement crisis interventions, we tailored a new intervention lowering the degree of direct emotional activation. However, we need some evidence on the effects of depression and psychotraumatic symptoms between 1 and 6 months after a loss. Method: We conducted a randomized controlled trial with two groups: control group (n = 18) and experimental group (n = 11) in two assessments (1 and 6 months after loss); both included a semi-structured interview (Socio-Demographic Questionnaire, Beck Depression Inventory and the Impact of Events Scale-Revised–IES-R). The experimental group had a cognitive-narrative program with four sessions: recalling; cognitive and emotional subjectivization; metaphorization; and projecting sessions. Results: Participants in the experimental and control groups have lower levels of depression and traumatic stress 6 months after a loss. Statistically significant results in emotional numbing IES-R sub-scale are observed. Conclusions: A brief narrative-based cost-effective intervention has a positive effect on depression, controlling the traumatic stress and time after a loss.

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Do Verbal and Tactile Cueing Selectively Alter Gluteus Maximus and Hamstring Recruitment During a Supine Bridging Exercise in Active Females? A Randomized Controlled Trial

Journal of Sport Rehabilitation ◽

10.1123/jsr.2016-0130 ◽

2018 ◽

Vol 27 (2) ◽

pp. 138-143 ◽

Cited By ~ 1

Author(s):

John H. Hollman ◽

Tyler A. Berling ◽

Ellen O. Crum ◽

Kelsie M. Miller ◽

Brent T. Simmons ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Controlled Trial ◽

Gluteus Maximus ◽

Control Group ◽

Adult Women ◽

Randomized Controlled ◽

Tactile Cues ◽

Hip Extension ◽

Experimental Group

Context: Hip extension with hamstring-dominant rather than gluteus maximus-dominant recruitment may increase anterior femoracetabular forces and contribute to conditions that cause hip pain. Cueing methods during hip extension exercises may facilitate greater gluteus maximus recruitment. Objective: We examined whether specific verbal and tactile cues facilitate gluteus maximus recruitment while inhibiting hamstring recruitment during a bridging exercise. Design: Randomized controlled trial. Setting: Biomechanics laboratory. Participants: 30 young adult women (age 24 [3] y; BMI 22.2 [2.4] kg/m2). Intervention: Participants were tested over 2 sessions, 1 week apart, while performing 5 repetitions of a bridging exercise. At their second visit, participants in the experimental group received verbal and tactile cues intended to facilitate gluteus maximus recruitment and inhibit hamstring recruitment. Control group participants received no additional cues beyond original instructions. Main Outcome Measures: Gluteus maximus and hamstring recruitment were measured with surface electromyography, normalized to maximal voluntary isometric contractions (MVICs). Results: Gluteus maximus recruitment was unchanged in the control group and increased from 16.8 to 33.0% MVIC in the cueing group (F = 33.369, P < .001). Hamstring recruitment was unchanged in the control group but also increased from 16.5 to 29.8% MVIC in the cueing group (F = 6.400, P = .02). The effect size of the change in gluteus maximus recruitment in the cueing group (Cohen’s d = 1.5, 95% CI = 0.9 to 2.2) was not significantly greater than the effect size in hamstring recruitment (Cohen’s d = 0.8, 95% CI = 0.1 to 1.5). Conclusions: Verbal and tactile cues hypothesized to facilitate gluteus maximus recruitment yielded comparable increases in both gluteus maximus and hamstring recruitment. If one intends to promote hip extension by facilitating gluteus maximus recruitment while inhibiting hamstring recruitment during bridging exercises, the cueing methods employed in this study may not produce desired effects.

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