MiDAS ENCORE: Randomized Controlled Study
Design and Protocol

Background: Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Study Design: Prospective, multi-center, randomized controlled, clinical study. Setting: Twenty-six interventional pain management centers throughout the United States. Objective: To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Methods: Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. Outcome Measures: The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Results: Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Limitations: Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. Conclusions: This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients. Key words: mild, lumbar spinal stenosis, LSS, epidural steroid injection, neurogenic claudication, ligamentum flavum

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MILD® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial

January 2018 - Pain Physician ◽

10.36076/ppj/2019.19.229 ◽

2016 ◽

Vol 4;19 (4;5) ◽

pp. 229-242 ◽

Cited By ~ 7

Author(s):

Ramsin Benyamin

Keyword(s):

Ligamentum Flavum ◽

Responder Rate ◽

Control Group ◽

Neurogenic Claudication ◽

Controlled Clinical Trial ◽

Epidural Steroid Injections ◽

Randomized Controlled ◽

Lumbar Spinal ◽

Epidural Steroid

Background: Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine, which is a major cause of pain and functional disability for the elderly. Neurogenic claudication symptoms are a hallmark of LSS, where patients develop low back or leg pain when walking or standing that is relieved by sitting or lumbar flexion. The treatment of LSS generally begins with conservative management such as physical therapy, home exercise programs, and oral analgesics. Once these therapies fail, patients commonly move forward with interventional pain treatment options such as epidural steroid injections (ESIs) or MILD® as the next step. Objective: To assess improvement of function and reduction in pain for Medicare beneficiaries following treatment with MILD (treatment group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy and to compare to a control group receiving ESIs. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Methods: Patients in this trial were randomized one to one into 2 study arms. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Outcomes are assessed using the Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the ESI group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy is the proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device- or procedure-related adverse events in each group. This report presents safety and efficacy results at 1-year follow-up. Outcomes at 2 years will be collected and reported for patients in the MILD group only. Results: At 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: There was a lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to adjunctive pain therapy study restrictions. Study enrollment was not limited to patients that had never received ESI therapy. Conclusions: One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year. Key words: MILD, minimally invasive lumbar decompression, interlaminar epidural steroid injections, ESI neurogenic claudication, ligamentum flavum, ENCORE, PILD, CED Study, LSS

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Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial

January 2018 - Pain Physician ◽

10.36076/ppj.2018.6.593 ◽

2018 ◽

Vol 1 (21;1) ◽

pp. 593-605

Author(s):

Seong-Soo Choi

Keyword(s):

Spinal Stenosis ◽

Lumbar Spinal Stenosis ◽

Controlled Trial ◽

Balloon Catheter ◽

Controlled Study ◽

Neurogenic Claudication ◽

Randomized Controlled ◽

Significant Difference ◽

Lumbar Spinal

Background: When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions. Objectives: This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up. Study Design: This study used a randomized, single-blinded, active-controlled trial design. Setting: This study took place in a single-center, academic, outpatient interventional pain management clinic. Methods: This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA. Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035). Limitations: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high. Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS. The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093). Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis

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MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results

January 2018 - Pain Physician ◽

10.36076/ppj/2016.19.25 ◽

2016 ◽

Vol 19 (2;2) ◽

pp. 25-37

Author(s):

Peter S. Staats

Keyword(s):

Clinical Trial ◽

Active Control ◽

Ligamentum Flavum ◽

Control Group ◽

Neurogenic Claudication ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Epidural Steroid

Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. Key words: MILD, lumbar central spinal stenosis, minimally invasive lumbar decompression, interlaminar epidural steroid injection, neurogenic claudication, ligamentum flavum, Oswestry Disability Index, ODI, Numeric Pain Rating Scale, NPRS, Zurich Claudication Questionnaire, ZCQ

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041528 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1528

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. 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 lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) 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, while improvements in both variables are maintained at four weeks follow-up.

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The added value of cognition-targeted exercise versus symptom-targeted exercise for multiple sclerosis fatigue: A randomized controlled pilot trial

PLoS ONE ◽

10.1371/journal.pone.0258752 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0258752

Author(s):

Azza Alketbi ◽

Salah Basit ◽

Nouran Hamza ◽

Lori M. Walton ◽

Ibrahim M. Moustafa

Keyword(s):

Multiple Sclerosis ◽

Clinical Outcome ◽

Outcome Measures ◽

Recruitment Rate ◽

Control Group ◽

Entire Study ◽

Randomized Controlled ◽

Significant Difference ◽

Intervention Protocol

Background Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue. Methods In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up. Results The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001). Conclusion The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.

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Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication

January 2018 - Pain Physician ◽

10.36076/ppj.2012/15/451 ◽

2012 ◽

Vol 6;15 (6;12) ◽

pp. 451-460

Author(s):

Timothy R. Deer

Keyword(s):

Spinal Stenosis ◽

Lumbar Spinal Stenosis ◽

Radicular Pain ◽

Neurogenic Claudication ◽

Lumbar Decompression ◽

Reduction Of Pain ◽

One Year ◽

Lumbar Spinal ◽

Over Time

Background: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root. Objective: To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression. Study Design: Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis. Setting: US interventional pain management practice. Methods: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year followup was available for 35 patients. Outcome Assessment: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year follow-up. Results: One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study. Limitations: Single-center study with no control group. Conclusions: In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS. Key words: Spine, lumbar, lumbar spinal stenosis, neurogenic claudication, decompression, ligamentum flavum, mild, percutaneous.

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Distal Chevron Osteotomy vs The Simple, Effective, Rapid, Inexpensive Technique (SERI) for Mild to Moderate Isolated Hallux Valgus: A Randomized Controlled Study

10.21203/rs.3.rs-17170/v1 ◽

2020 ◽

Author(s):

Ezequiel Palmanovich ◽

Nissiom Ohana* - equal first author contribution ◽

Ilan Small ◽

Iftach Hetsroni ◽

Eyal Amar ◽

...

Keyword(s):

Minimally Invasive ◽

Hallux Valgus ◽

Controlled Study ◽

Wound Complications ◽

Invasive Technique ◽

Control Group ◽

Chevron Osteotomy ◽

The Mean ◽

One Year

Abstract Background Hallux valgus is a common foot deformity that leads to functional disability with serious sequelae. Minimally invasive surgery is often used to treat hallux valgus in order to reduce wound complications and improve recovery time. The objective of this study was to compare a Simple, Effective, Rapid, Inexpensive (SERI) technique with a simple Chevron technique in patients with minimum of one-year follow. Methods and Materials Between the years 2014-2015 we performed a prospective study comparing the SERI minimally invasive technique to treat symptomatic hallux valgus with a standard chevron osteotomy technique. All procedures were performed by a single fellowship trained foot and ankle surgeon. Twenty-one patients were randomized to the SERI cohort and 15 to the standard Chevron technique. Results The mean pre-operative intermetatarsal angle (IMA) of the SERI group was 14.8 ± 1.9 (11.9 - 22.9). The mean pre-operative IMA of the Chevron control group was 13.3 ± 2.3 (10.4 -18.2) (p = 0.038). The mean IMA two weeks after surgery was 6.0 ± 2.3 (2.4-12) in the SERI group, and 6.1 ± 3 (2.6-13.1) in the control group. At the two week and one year follow up, there was no significant difference found in the IMA between the two groups (p = 0.871). Neither groups reported symptomatic transfer metatarsalgia throughout the follow up period. The SERI group had increased metatarsophalangeal joint (MTPJ) motion (p < 0.001) however, all other parameters with similar. Conclusion The SERI technique provided comparable outcomes at up to one year follow up when compared to a standard Chevron osteotomy for moderate hallux valgus. This study demonstrated good reproducible results using the SERI technique for moderate hallux valgus.

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Effect of the Use of WeChat to Disseminate Preoperative Health Education to Parents of Children with Restrictive Ventricular Septal Defects: A Prospective Randomized Controlled Study

The Heart Surgery Forum ◽

10.1532/hsf.3323 ◽

2020 ◽

Vol 23 (6) ◽

pp. E897-E901

Author(s):

Qiliang Zhang ◽

Ning Xu ◽

Shuting Huang ◽

Qiang Chen ◽

Hua Cao

Keyword(s):

Health Education ◽

Ventricular Septal Defect ◽

Septal Defect ◽

Preoperative Care ◽

Randomized Controlled Study ◽

Controlled Study ◽

Control Group ◽

Loss To Follow Up ◽

Randomized Controlled

Background: This study explored the clinical effect of implementing WeChat-based preoperative health education for parents of children with restrictive ventricular septal defect. Methods: A prospective randomized controlled study was conducted in a provincial hospital on the southeast coast of China. Participants were randomly divided into an intervention (WeChat) group (n = 35) and a control group (leaflet) group (n = 35). The study explored the parents’ knowledge of preoperative care, the follow-up rate, and complications of children with restrictive ventricular septal defect. Results: The score of preoperative care knowledge of the WeChat group (66.9 ± 3.5) was significantly higher than that of the leaflet group (47.3 ± 6.3) (P = .006). Compared with the score of care knowledge at the first visit, the score of the WeChat group at the preoperation was significantly higher (P < .05), whereas the increase in the score of the leaflet group was not significant. The rate of lost follow-up in the WeChat group (0%) was significantly lower than in the leaflet group (16.7%) (P = .02). The complications in the leaflet group were significantly higher than in the WeChat group. Conclusions: Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents’ knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.

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A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519858395 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1747-1756

Author(s):

Claudia Uras ◽

Simona Mastroeni ◽

Stefano Tabolli ◽

Cinzia Masini ◽

Sabatino Pallotta ◽

...

Keyword(s):

Systemic Sclerosis ◽

Confidence Interval ◽

Statistical Significance ◽

Mouth Opening ◽

Controlled Study ◽

Control Group ◽

Educational Materials ◽

Face To Face ◽

Randomized Controlled

Objective: To test the effectiveness of an educational intervention including “face to face” training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific “face-to-face” interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant ( P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials.

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Partial time use of anterior repositioning splints in the management of TMJ pain and dysfunction: a one-year controlled study

Journal of Applied Oral Science ◽

10.1590/s1678-77572005000400006 ◽

2005 ◽

Vol 13 (4) ◽

pp. 345-350 ◽

Cited By ~ 19

Author(s):

Paulo César Rodrigues Conti ◽

João Evandro Silva Miranda ◽

Ana Cláudia C. Ferreira Conti ◽

Luiz Fernando Pegoraro ◽

Carlos dos Reis Pereira de Araújo

Keyword(s):

Time Use ◽

Open Bite ◽

Controlled Study ◽

Control Group ◽

Final Sample ◽

Muscle Tenderness ◽

Tmj Pain ◽

One Year ◽

Articular Pain

This study aimed at evaluating the effectiveness of partial use of anterior repositioning appliances in the management of TMJ pain and dysfunction when compared to stabilization splints and a control group in a one-year follow-up. Sample was initially constituted by 60 patients, randomly divided into three groups: I- stabilization splints, II- repositioning splints and III- no treatment. The whole sample was evaluated by means of TMJ and muscle palpation, mandibular AROM, analysis of occlusal contacts, joint sounds inspection and Visual Analogue Scale (VAS) for one year; 52 patients composed the final sample. A significant (after 15 days) improvement in pain report (VAS) and palpation index was found for group II (p<0.01). The occurrence of occlusal alterations as posterior open bite or gross interferences after the splint therapy and increased muscle tenderness were not problems in this study. Similar results in joint noises reduction were observed for the entire sample. It was concluded that controlled partial use of repositioning splints is a beneficial tool in the management of intra-articular pain and dysfunction, with no risks of irreversible occlusal changes.

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