Clinical Results of the NUsurface® Meniscus Implant versus Non-Surgical Controls at 24 months: Data from a Pooled cohort of a randomized controlled study and single arm study

Objectives: To demonstrate comparative KOOS outcomes (Symptoms, Pain, ADL, Sports/Rec, QoL, and Overall) of a synthetic meniscus implant versus non-surgical controls in treatment of persistent post meniscectomy knee pain. Methods: 242 patients enrolled in a pooled population, randomized controlled trial (RCT) and single-arm study, comparing the investigational device to non-surgical standard of care. Of the first 100 patients enrolled, whose follow-up has exceeded 24 months, 65 patients were treated with the meniscus implant, and 35 were treated non-surgically (Table 1). Validated KOOS scores at baseline, 6-week, 6-month, 12-month, and 24-month time points were obtained from all patients where a “clinically significant improvement” was considered to be an increase of 20 KOOS points, based on Roos et al., (2003). The investigational and control cohorts were compared at each time point using a two tailed t-test. All baseline cohort comparisons of demographics and KOOS scores were not statistically different (p>0.05). Results: Improvement in KOOS Pain for the investigational vs control cohorts at 6-months was 25.0 vs 10.5 points at 6-months, 31.1 vs 14.5 points at 12-months, and 29.5 vs 13.6 points at 24-months, respectively (Figure 1). Similarly, improvement in KOOS Overall for investigational vs controls was 23.3 vs 8.0 points at 6-months, 29.2 vs 11.4 points at 12-months, and 29.1 vs 13.4 points at 24-months, respectively. These data show a statistically significant improvement, above the clinically meaningful threshold, in the investigational arm versus the control arm as early as 6 months (p<0.001) and continues through the 12-month timepoint (p<0.001) and the 24-month timepoint (p<0.001). At 24 months, 5 (7.7%) investigational vs. 5 (14.3%) control patients were no longer qualified to remain in the study, and deemed study failures, due to removal of the investigational device, and due to non-surgical control patients receiving surgical intervention (Table 1). Adverse event analysis showed that at 12 months, more patients progressed to advanced knee reconstructive procedures in the non-surgical, control group (n=4, 11.4%) than in the surgical, investigational group (n=2, 3.1%). Conclusion: Early results of effectiveness using KOOS subscales and KOOS overall are encouraging. The investigational treatment showed statistically different outcomes, above the clinically important threshold, at 6, 12 and 24 months compared to non-surgical controls. The clinical study is ongoing, with long-term results to be reported in the future. [Table: see text][Figure: see text]

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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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Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽

10.5402/2012/827972 ◽

2012 ◽

Vol 2012 ◽

pp. 1-5 ◽

Cited By ~ 30

Author(s):

Paul Ratanasiripong ◽

Nop Ratanasiripong ◽

Duangrat Kathalae

Keyword(s):

Nursing Students ◽

Stress Level ◽

Clinical Training ◽

Intervention Program ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Moderate Increase ◽

Randomized Controlled ◽

The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

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Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

Brain Sciences ◽

10.3390/brainsci11060818 ◽

2021 ◽

Vol 11 (6) ◽

pp. 818

Author(s):

Yann Kerautret ◽

Aymeric Guillot ◽

Sébastien Daligault ◽

Franck Di Rienzo

Keyword(s):

Skin Conductance ◽

Muscle Pain ◽

Controlled Trial ◽

Muscle Relaxation ◽

Well Being ◽

Self Report ◽

Controlled Study ◽

Control Group ◽

Foam Rolling ◽

Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2018-0028 ◽

2018 ◽

Vol 16 (2) ◽

Cited By ~ 2

Author(s):

Ilana Levy ◽

Samuel Attias ◽

Lior Cohen ◽

Nadav Stoppelmann ◽

Dan Steinberger ◽

...

Keyword(s):

Side Effects ◽

Postoperative Pain ◽

Analgesic Effect ◽

Pain Treatment ◽

Standard Of Care ◽

Acupuncture Group ◽

Controlled Study ◽

Control Group ◽

Pain Level ◽

Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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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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A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates

Clinical Nursing Research ◽

10.1177/10547738211061815 ◽

2021 ◽

pp. 105477382110618

Author(s):

Ayşe Özge Deniz ◽

Ayfer Açikgöz

Keyword(s):

Controlled Trial ◽

Controlled Study ◽

Procedural Pain ◽

Control Group ◽

Intergroup Difference ◽

Inclusion Criteria ◽

Sedation Scale ◽

Neonatal Pain ◽

Randomized Controlled ◽

Pain Scores

This randomized controlled study aimed to determine the effects of acupressure and foot reflexology on procedural pain during heel-lancing in newborns. This study was conducted with 105 neonates (35 foot reflexology group, 35 acupressure group, and 35 control group) who met the inclusion criteria and who were delivered by cesarean section between October 2017 and March 2018 at a state hospital in Turkey. A “Newborn Information Form” and a “Neonatal Pain, Agitation, and Sedation Scale” (N-PASS) were used to collect data. The study found a significant intergroup difference between pain scores of neonates during the procedures ( p < .05). Advanced analyses found that the pain scores in the acupressure and foot reflexology groups were similar, whereas the pain scores in the control group were higher than in the other two groups. Acupressure and foot reflexology administered during heel lancing in newborns are effective methods for reducing pain.

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Efficacy of an Objective Structured Clinical Examination Training Approach for Training Pharmacy Students in Diabetes Mellitus Counseling: A Randomized Controlled Trial

Pharmacy ◽

10.3390/pharmacy8040229 ◽

2020 ◽

Vol 8 (4) ◽

pp. 229

Author(s):

Imaneh Farahani ◽

Samieh Farahani ◽

Maira A. Deters ◽

Holger Schwender ◽

Stephanie Laeer

Keyword(s):

Diabetes Mellitus ◽

Communication Skills ◽

Controlled Trial ◽

Objective Assessment ◽

Intervention Group ◽

Pharmacy Students ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Training Approach

Pharmacists’ tasks are multifaceted and include, for example, vital counseling and communication skills. Objective Structured Clinical Examinations (OSCEs) could be used to train pharmacy students in these skills. Our study sought to determine the efficacy of our OSCE training approach for training pharmacy students’ counseling and communication skills on diabetes mellitus compared to a control group. This randomized controlled study was conducted with pharmacy students using a pre-post-design. The intervention group completed diabetes OSCE training, while the control group solved diabetes patient cases using subjective, objective, assessment, and plan notes. Before and after the respective training, both groups completed OSCEs evaluating counseling and communication skills. Before each OSCE encounter, the participants completed a self-assessment questionnaire and, upon completion of the seminar, filled out a satisfaction survey. The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group. Both groups were generally satisfied with the seminar. These results demonstrate that our OSCE training approach allows for the effective training of pharmacy students’ diabetes counseling and communication skills and suggests the inclusion of such a skill-based approach more widely in pharmacy students’ education.

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Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

10.22514/sv.2021.144 ◽

2021 ◽

Keyword(s):

Quality Of Life ◽

Nk Cells ◽

Nk Cell ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

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Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

10.2196/preprints.13393 ◽

2019 ◽

Author(s):

Naira Topooco ◽

Sandra Byléhn ◽

Ellen Dahlström Nysäter ◽

Jenny Holmlund ◽

Johanna Lindegaard ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adolescent Depression ◽

Controlled Trial ◽

National Level ◽

Cognitive Behavioral ◽

Controlled Study ◽

Control Group ◽

Depression Symptoms ◽

Group Effect ◽

Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic><.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

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