Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients: A randomized controlled trial

ABSTRACT Objective: To determine if 2-DeNT Oral Topical Powder is an effective treatment for traumatic oral ulcers. Materials and Methods: Of the 46 patients who were randomly allocated, 20 patients from the experimental group and 17 from the placebo control group completed the study. The patients, operators, and evaluators were all blinded. Patients applied the powder twice a day and completed a diary twice a day for 10 days. The diary was used to monitor the size of the lesions and pain levels (using a 10-cm visual analog scale). Results: By day 5, the ulcers in the experimental group had reduced in size by approximately 70%; and ulcers in the control group had reduced in size by 56%. The experimental-group ulcers were significantly (P < .05) smaller than the control-group ulcers from day 5 through day 9. Ulcers in the experimental group were completely resolved by day 8, whereas control-group ulcers were still present on day 10. Patients experienced a significant amount of stimulated pain until the night of day 2 in the experimental group and until the night of day 5 in the control group, but group differences in pain were not statistically significant. Conclusions: The 2DeNT Oral Topical powder was more effective than the placebo powder at accelerating the healing of oral traumatic ulcers.

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Is manual therapy based on neurodynamic techniques effective in the treatment of carpal tunnel syndrome? A randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518805213 ◽

2018 ◽

Vol 33 (3) ◽

pp. 408-417 ◽

Cited By ~ 12

Author(s):

Tomasz Wolny ◽

Pawel Linek

Keyword(s):

Carpal Tunnel Syndrome ◽

Carpal Tunnel ◽

Symptom Severity ◽

Nerve Conduction ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Randomized Controlled ◽

Tunnel Syndrome ◽

Experimental Group

Objective: The aim of this study was to evaluate the efficacy of manual therapy based on neurodynamic techniques in conservative treatment of carpal tunnel syndrome. Design: Randomized controlled trial. Setting: Several medical outpatient clinics in the south of Poland. Participants: The study included 103 patients with mild and moderate carpal tunnel syndrome (mean age = 53.95, SD = 9.5) years, who were randomly assigned to a neurodynamic techniques group (experimental group, n = 58) or a group without treatment (control group, n = 45). Intervention: Neurodynamic techniques were used in the experimental group. Treatment was conducted twice weekly (20 sessions). Control group did not receive treatment. Main measures: Nerve conduction study, pain, symptom severity and functional status of Boston Carpal Tunnel Questionnaire, and strength of cylindrical and pincer grips were assessed at baseline and immediately after treatment (nerve conduction study one month after treatment). Results: Baseline assessment revealed no group differences in any assessed parameters ( P > 0.05). There were significant differences between groups after treatment, including nerve conduction (e.g. sensory conduction velocity: experimental group: 38.3 m/s, SD = 11.1 vs control group: 25.9 m/s, SD = 7.72, P < 0.01). Significant changes also occurred in pain (experimental group: 1.38, SD = 1.01 vs control group: 5.46, SD = 1.05, P < 0.01), symptom severity (experimental group: 1.08, SD = 0.46 vs control group: 2.87, SD = 0.68, P < 0.01), and functional status (experimental group: 1.96, SD = 0.64 vs control group: 2.87, SD = 1.12, P < 0.01). There were no group differences in strength ( P > 0.05). Conclusion: The use of neurodynamic techniques in conservative treatment for mild to moderate forms of carpal tunnel syndrome has significant therapeutic benefits.

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Training family to assist with physiotherapy for older people transitioning from hospital to the community: a pilot randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519853874 ◽

2019 ◽

Vol 33 (10) ◽

pp. 1625-1635 ◽

Cited By ~ 4

Author(s):

Katherine Lawler ◽

Nora Shields ◽

Nicholas F Taylor

Keyword(s):

Randomized Controlled Trial ◽

Older People ◽

Controlled Trial ◽

Caregiver Strain ◽

Group Differences ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group ◽

Pilot Randomized Controlled Trial

Objective:To investigate the safety and effectiveness of augmenting physiotherapy with family-assisted therapy, to inform a future, fully powered trial.Design:Parallel pilot randomized controlled trial.Setting:Transition Care Program.Participants:Thirty-five older adults with multimorbidity, recently hospitalized, with a mean age of 84.1 years (SD = 6.1 years) and mean Modified Barthel Index of 67.8 units (SD = 19.2 units), and 40 family members.Interventions:The control group ( n = 18) received usual physiotherapy care. The experimental group ( n = 17) received usual physiotherapy care and family-assisted therapy from a family member trained by a physiotherapist.Main measures:Primary outcomes were falls-related self-efficacy measured by the Short Falls Efficacy Scale – International and falls during the intervention period. Secondary outcomes included daily steps, EQ-5D-3L (three-level version of the EuroQoL five-dimensional health-related quality of life questionnaire) and ICECAP-O (ICEpop CAPability measure for Older people), Modified Barthel Index and Modified Caregiver Strain Index.Results:There were no between-group differences for falls-related self-efficacy. Relative to the control group, the experimental group was observed to have a reduced risk of falling (relative risk = 0.38, 95% confidence interval (CI) = 0.09–1.60) and a reduced falls rate (incidence rate ratio = 0.22, 95% CI = 0.04–1.20) was of borderline statistical significance. The experimental group walked a mean of 944 daily steps more than the control group (95% CI = 139–1748) and had a significant reduction in activity limitation. There were no between-group differences for quality of life or caregiver strain.Conclusion:Augmenting physiotherapy with family-assisted therapy is feasible for older people transitioning from hospital to the community. A fully powered randomized controlled trial is indicated.

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Comparison between Tramadol and Butorphanol for Treating Postoperative Catheter-Related Bladder Discomfort: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/6002059 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Feihong Lin ◽

Kaiyang Shao ◽

Wei Pan ◽

Dongdong Liang ◽

Zhangfan Zhao ◽

...

Keyword(s):

Pain Score ◽

Receptor Agonist ◽

Controlled Trial ◽

Sedation Score ◽

Postanesthesia Care Unit ◽

Control Group ◽

Analog Scale ◽

Curative Effect ◽

Randomized Controlled ◽

Experimental Group

Background. Intraoperative catheterization often leads to postoperative catheter-related bladder discomfort (CRBD) during the restoration period. This study aimed to assess the curative effect of butorphanol as a K receptor agonist in the treatment of postoperative CRBD. Patients and Approaches. Sixty patients with CRBD who underwent elective nonurological surgery at the postanesthesia care unit were randomly and evenly assigned to two groups. The control group was slowly injected with tramadol 1.5 mg/kg using a Murphy dropper, whereas the experimental group was intravenously injected with butorphanol 0.02 mg/kg. Severity, pain score, and sedation score of CRBD were evaluated at 0 min, 5 min, 15 min, 30 min, 1 h, and 6 h later. Results. The severity score of CRBD and visual analog scale pain score were lower in the butorphanol group than in the control group, whereas the sedation score was higher in the butorphanol group than in the control group. Conclusion. Butorphanol relieves on postoperative urination discomfort and pain compared with tramadol.

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Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

Bulletin of Faculty of Physical Therapy ◽

10.1186/s43161-021-00030-2 ◽

2021 ◽

Vol 26 (1) ◽

Author(s):

Shamekh Mohamed El-Shamy ◽

Ehab Mohamed Abd El Kafy

Keyword(s):

Cerebral Palsy ◽

Physical Therapy ◽

Muscle Tone ◽

Controlled Trial ◽

Gait Pattern ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Gait Parameters ◽

Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

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The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03625-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anne Njogu ◽

Si Qin ◽

Yujie Chen ◽

Lizhen Hu ◽

Yang Luo

Keyword(s):

Transcutaneous Electrical Nerve Stimulation ◽

Controlled Trial ◽

Labor Pain ◽

Control Group ◽

Electrical Nerve Stimulation ◽

Randomized Controlled ◽

Active Labor ◽

Vas Scores ◽

Experimental Group ◽

First Stage Of Labor

Abstract Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group (n = 161) and control group (n = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group (p < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group (p < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995. Registered on 11/12/2020, ‘retrospectively registered.

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A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-pelvic Stability and Adductor Strength in Women Soccer Players. A Randomized Controlled Study.

10.21203/rs.3.rs-108504/v1 ◽

2020 ◽

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Controlled Trial ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Abstract Background: Abdominal and lumbo-pelvic stability alterations may origin lower limb injuries, such as for example adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: This randomized controlled trial conducted over an 8-week period included 25 female footballers randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbo-pelvic stability and adductor strength.Results. Lumbo-pelvic stability after surgery was higher in the control group (MD: 4.84 vs MD: 9.58; p < .01) with differences in the analysis of repeated measures (p<.001), but not in group interaction (p =.26). Changes were found in adductor strength in the experimental group (MD: -2.48; p<.001 in the left adductor; MD: -1.48; p<.01 in right adductor) and control group (MD: -1.68; p<.001 in the left adductor; MD: -2.05; p<.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p<.001) and right (p<.001) adductor strength.Conclusions. An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength and flexibility, while improvements are maintained at four weeks follow-up. Trial Registration Number: NCT03617887.

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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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Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520923135 ◽

2020 ◽

Vol 34 (7) ◽

pp. 938-947 ◽

Cited By ~ 1

Author(s):

Mehdi Zemestani ◽

Sharmin Mozaffari

Keyword(s):

Emotion Regulation ◽

Depressive Symptoms ◽

Controlled Trial ◽

Psychological Flexibility ◽

Well Being ◽

Control Group ◽

Psychological Well Being ◽

Randomized Controlled ◽

Acceptance And Commitment ◽

Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

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