scholarly journals Percutaneous Epidural Lysis of Adhesions in Chronic Lumbar Radicular Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 3;16 (3;5) ◽  
pp. 185-196 ◽  
Author(s):  
Ludger Gerdesmeyer
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Radicular Pain ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Evidence Based ◽  
Success Rates ◽  
Percent Change ◽  
Randomized Controlled ◽  
Vas Scores

Background: Chronic radicular pain can occur after disc pathology and failed back surgery. An evidence-based effective therapeutic option is not available nor does a gold standard exist. Objectives: A randomized controlled trial to analyze the clinical efficacy of percutaneous epidural lysis of adhesions in chronic radicular pain. Study Design: Prospective randomized placebo controlled interventional trial. Power calculation based on a feasibility trial. Setting: Medical university centers. Methods: Within 4 years a total of 381 patients with chronic radicular pain lasting longer than 4 months which failed to respond to conservative treatments were screened and 90 patients were enrolled. They were randomly assigned to receive either percutaneous neurolysis or placebo with concealed allocation in permuted blocks of 4 to 8, stratified by treatment center. The primary outcome measure was the differences in percent change of Oswestry Disability Index (ODI) scores 3 months after intervention. Secondary outcome measures were difference in percent change of ODI scores and Visual Analog Scale (VAS) 6 and 12 months after intervention and success rates defined as at least 50% reduction in ODI scores and VAS scores (mean change from baseline) at 3, 6, and 12 months after treatment. Explorative, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the t-test for 2 independent samples for quantitative data and Fisher’s exact test for binary data. Results: The ODI and VAS scores as well as the success rates for ODI vs VAS were significantly better 3, 6, and 12 months in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 26.4 ± 10.8 after 3 months. The placebo group improved from 55.4 ± 11.5 to 41.8 ± 14.6 (P < 0.01). VAS improved from 6.7 ± 1.1 to 2.9 ± 1.9 in the active group and from 6.7 ± 1.1 to 4.8 ± 2.2 (P < 0.01) after placebo. Twelve month follow-up shows further improvement, the differences remain significant. In multiple linear regression, forward and backward variable selection methods resulted in the same covariate model confirming the univariate result for group comparison in the primary analysis. No severe side effects occurred but minor transient neurological effects such as partial sensomotoric deficits did. One dura puncture and one catheter displacement were found. Limitations: Specific effects of single treatment components cannot be specified because there was no imaging examination after treatment. Conclusion: Based on the findings of our study as well as other studies, we believe the minimally invasive percutaneous adhesiolysis procedure should be the first choice treatment option for patients with chronic lumbosacral radicular pain who present with clinical history and findings similar to those of the patients enrolled in our study. Key words: Lysis, low back pain, randomized controlled trial (RCT), placebo, epidural, radiculopathy, outcome, evidence-based medicine

scholarly journals Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10 Year Follow-up of a Randomized Controlled Trial

2021 ◽  
pp. 359-367
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Radicular Pain ◽  
Feasibility Trial ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Factor ◽  
One Year

BACKGROUND: No long-term follow-up data exist in any treatment for chronic radicular pain occurring with disc pathology and after failed back surgery. A previous randomized controlled trial (RCT) has proven efficacy in short-term follow-up as an evidence-based effective therapeutic option. OBJECTIVES: Long term data is needed to determine the efficacy and cost- effectiveness of minimal invasive procedures. The present study reports 10 year follow-up results from the randomized trial. STUDY DESIGN: A prospective, randomized, placebo-controlled, interventional clinical trial. A power calculation was based on a previous feasibility trial. SETTING: University medical centers. METHODS: After a 4 year enrollment phase, 381 patients with chronic radicular pain persisting beyond 4 months, who failed conservative treatments, were screened. Ninety patients were enrolled. Patients were randomly assigned to receive percutaneous epidural lysis of adhesions or placebo with concealed allocation in permuted blocks of 4 to 8 patients each, and stratified by treatment center. The primary outcomes were a mean change of the Oswestry Disability Index (ODI) scores and Visual Analog Scale (VAS), one and 10 years after intervention. For each rating scale an analysis of variance with the within-patient factor time (baseline, one year follow-up, 10 year follow-up) and the between-patient factor treatment (lysis, placebo) was used. RESULTS: Homogeneity was shown at baseline between the groups. The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 9.6 ± 9.3 after one year and to 11.7 ± 14.2 after 10 years. The placebo group also improved from 55.4 ± 11.5 to 30.7 ± 14.2 after one year and to 24.8 ± 12.0 after 10 years. The VAS improved from 6.7 ± 1.1 to 1.2 ± 1.1 after one year and to 1.5 ± 1.4 after 10 years in the lysis group and from 6.7 ± 1.1 to 2.8 ± 1.5 after one year and to 2.9 ± 1.3 after 10 years after placebo intervention. The statistical difference of the ODI and VAS between the treatment and control groups remain significant up to 10 years. No treatment-related severe adverse effects occurred within the 10 years, but minor transient neurological effects were seen directly after the intervention. LIMITATIONS: The long-term effects of single treatment components cannot be specified as no imaging examination was performed at 10 year follow-up. A large variety of unanalyzed noninvasive treatments were done within the 10 years. Some patients did not clearly remember the intervention after 10 years. Uncontrolled effects such as higher inhomogeneity of biometric properties, concomitant therapies, pain tolerance level, or just social effects could occur, but were not analyzed in the trial. CONCLUSION: This is the first 10 year follow-up report of a placebo-controlled RCT showing efficacy of the minimally invasive percutaneous adhesiolysis procedure for patients with chronic lumbosacral radicular pain. No alternative evidence-based treatment modality with 10 year follow-up is available to be recommended. This procedure should be considered as the first treatment option for patients with chronic lumbosacral radicular pain. KEY WORDS: Disc herniation, RCT, disc disease, radiculopathy, back pain, failed back syndrome, epidural, lysis of adhesions, adhesiolysis

scholarly journals Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis

2018 ◽  
Vol 39 (10) ◽  
pp. 1151-1161 ◽  
Author(s):  
Shawn Cazzell ◽  
Jordan Stewart ◽  
Patrick S. Agnew ◽  
John Senatore ◽  
Jodi Walters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Plantar Fasciitis ◽  
Controlled Trial ◽  
The United States ◽  
Secondary Outcome ◽  
Human Amnion ◽  
Control Subjects ◽  
Randomized Controlled ◽  
Vas Scores

Background: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. Methods: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. Subjects were randomized to receive 1 injection, in the affected area, of micronized dHACM (n=73) or 0.9% sodium chloride placebo (n=72). Safety/efficacy assessments were conducted at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months postinjection, using visual analog scale (VAS) for pain, Foot Function Index–Revised (FFI-R) score, and presence/absence of adverse events. Primary outcome was mean change in VAS score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Secondary outcome was mean change in FFI-R score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Results: Baseline VAS scores were similar between groups. At the 3-month follow-up, mean VAS scores in the treatment group were 76% lower compared with a 45% reduction for controls ( P < .0001), FFI-R scores for treatment subjects had mean reduction of 60% versus baseline, whereas control subjects had mean reduction of 40% versus baseline ( P = .0004). Of 4 serious adverse events, none were related to study procedures. Conclusion: Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. Level of Evidence: Level I, prospective randomized trial.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

scholarly journals 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

2021 ◽  
Author(s):  
Timothy Davis ◽  
Afrida Sara ◽  
Terry Nguyen ◽  
John Kenneth Burkus
Keyword(s):  
Randomized Controlled Trial ◽  
Back Pain ◽  
Controlled Trial ◽  
Single Site ◽  
Low Back ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Disc Tissue ◽  
Tissue Allograft ◽  
Vas Scores

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).

scholarly journals 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

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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