Astigmatic correction with implantation of a light adjustable vs monofocal lens: a single site analysis of a randomized controlled trial

Abstract Background: Disruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. Methods: We assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.Results: At 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.Conclusions: Clinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registration: The trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

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Treatment of Degenerated Intervertebral Discs using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-Site Outcomes with Aggregate and Longer-term Follow-Up Data

10.21203/rs.3.rs-831525/v1 ◽

2021 ◽

Author(s):

Timothy Davis ◽

Afrida Sara ◽

Terry Nguyen ◽

John Kenneth Burkus

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Controlled Trial ◽

Single Site ◽

Low Back ◽

Disc Disease ◽

Randomized Controlled ◽

Disc Tissue ◽

Tissue Allograft ◽

Vas Scores

Abstract BackgroundDisruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. MethodsWe assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.ResultsAt 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.ConclusionsClinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registrationThe trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

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LAPAROENDOSCOPIC SINGLE-SITE SURGERY VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPY IN OVARIAN DRILLING: A RANDOMIZED CONTROLLED TRIAL

Fertility and Sterility ◽

10.1016/j.fertnstert.2020.08.1368 ◽

2020 ◽

Vol 114 (3) ◽

pp. e475-e476

Author(s):

Ahmed Mohamed Bahaaeldin Mohamed ◽

Haitham Fathy Gad ◽

Maya Mahmoud Abdelrazek

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Single Site ◽

Randomized Controlled ◽

Laparoendoscopic Single Site ◽

Ovarian Drilling ◽

Laparoendoscopic Single Site Surgery ◽

Single Site Surgery

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Erratum to: comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial

Trials ◽

10.1186/1745-6215-15-148 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Astrid Lehner ◽

Martin Schecklmann ◽

Peter M Kreuzer ◽

Timm B Poeppl ◽

Rainer Rupprecht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Single Site ◽

Chronic Tinnitus ◽

Clinical Effects ◽

Randomized Controlled

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Does an Eczema Action Plan Improve Atopic Dermatitis? A Single-Site Randomized Controlled Trial

Clinical Pediatrics ◽

10.1177/0009922818795906 ◽

2018 ◽

Vol 57 (14) ◽

pp. 1624-1629 ◽

Cited By ~ 1

Author(s):

Julia Brown ◽

Nicole W. Weitz ◽

Amy Liang ◽

Melissa S. Stockwell ◽

Suzanne Friedman

Keyword(s):

Randomized Controlled Trial ◽

Atopic Dermatitis ◽

Positive Impact ◽

Action Plan ◽

Controlled Trial ◽

Treatment Options ◽

Single Site ◽

Care Group ◽

Randomized Controlled ◽

The Impact

The multitude of treatment options for atopic dermatitis (AD) makes management frustrating for providers and patients. Eczema action plans (EAPs) have been proposed to improve parental and provider management. We developed a single-site randomized controlled trial to evaluate the impact of an EAP on quality of life (QOL), provider knowledge, and comfort with AD management. Providers were randomized into an EAP-use group and a traditional care group. All patients completed validated AD QOL surveys, and those with AD were verbally administered the survey 1 month later. Providers’ perceptions on managing AD were compared in the EAP and usual use groups. Parents in the EAP group demonstrated a significantly increased understanding of AD treatment, and providers in the EAP group had a significantly increased understanding and management of AD. The EAP is a feasible tool that can be integrated into a busy clinic practice with a positive impact on physicians and patients.

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