Is Saline Injection a True Sham/Placebo Treatment in Randomized Controlled Trials? A Systematic Review

Objective: To explore whether saline is a real sham/placebo agent, or it has potential therapeutic effects when used as control treatment in randomized controlled trials for the management of discogenic low back pain. Methods: A comprehensive literature search was conducted investigating the effects of saline as a placebo in the treatment of chronic pain when administered into the intervertebral disc. Following stepwise filtering, selected articles were assessed for their levels of evidence, followed by a discussion of their contribution to the understanding of the role of saline in chronic pain management. Results: Out of 95 articles that described the administration of intradiscal saline solution used as a placebo for chronic pain management, 8 articles met all of the inclusion criteria. Their levels of evidence ranged from 1a to 4 (Oxford Centre CEBM). Intradiscal administration of saline solution was found to have measurable therapeutic benefits. In some studies, the pain relief was similar to that provided by local anaesthetics and steroids. Conclusion: Although the exact mechanism of the analgesic effects of saline is not clear, yet the use of intradiscal saline appears to have some analgesic benefits like local anaesthetics and steroids when used individually. Researchers should practice caution when designing RCTs using intradiscal saline injection as a sham/placebo treatment for the control arm or maybe, when possible, avoid the use of intradiscal saline injection as a sham treatment.

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Cognitive behavioral therapy for insomnia in patients with chronic pain – A systematic review and meta-analysis of randomized controlled trials

Sleep Medicine Reviews ◽

10.1016/j.smrv.2021.101460 ◽

2021 ◽

Vol 60 ◽

pp. 101460

Author(s):

Janannii Selvanathan ◽

Chi Pham ◽

Mahesh Nagappa ◽

Philip W.H. Peng ◽

Marina Englesakis ◽

...

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Cognitive Behavioral Therapy ◽

Randomized Controlled Trials ◽

Behavioral Therapy ◽

Meta Analysis ◽

Cognitive Behavioral ◽

Controlled Trials ◽

Randomized Controlled

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Total extraperitoneal (TEP) versus laparoscopic transabdominal preperitoneal (TAPP) hernioplasty: systematic review and trial sequential analysis of randomized controlled trials

Hernia ◽

10.1007/s10029-021-02407-7 ◽

2021 ◽

Author(s):

Alberto Aiolfi ◽

Marta Cavalli ◽

Simona Del Ferraro ◽

Livia Manfredini ◽

Francesca Lombardo ◽

...

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Randomized Controlled Trials ◽

Sequential Analysis ◽

Hernia Recurrence ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Transabdominal Preperitoneal ◽

Tapp Repair

Abstract Purpose To examine the updated evidence on safety, effectiveness, and outcomes of the totally extraperitoneal (TEP) versus the laparoscopic transabdominal preperitoneal (TAPP) repair and to explore the timely tendency variations favoring one treatment over another. Methods Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). MEDLINE, Scopus, Web of Science, Cochrane Central Library, and ClinicalTrials.gov were consulted. Risk Ratio (RR), weighted mean difference (WMD), and 95% confidence intervals (CI) were used as pooled effect size measures. Results Fifteen RCTs were included (1359 patients). Of these, 702 (51.6%) underwent TAPP and 657 (48.4%) TEP repair. The age of the patients ranged from 18 to 92 years and 87.9% were males. The estimated pooled RR for hernia recurrence (RR = 0.83; 95% CI 0.35–1.96) and chronic pain (RR = 1.51; 95% CI 0.54–4.22) were similar for TEP vs. TAPP. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus supporting true negative results while the information size was calculated as adequate for both outcomes. No significant differences were found in term of early postoperative pain, operative time, wound-related complications, hospital length of stay, return to work/daily activities, and costs. Conclusions TEP and TAPP repair seems comparable in terms of postoperative hernia recurrence and chronic pain. The cumulative evidence and information size are sufficient to provide a conclusive evidence on recurrence and chronic pain. Similar trials or meta-analyses seem unlikely to show diverse results and should be discouraged.

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UT4 Comparison Of The Performance Of EQ-5D and SF-6D In Patients With Chronic Pain –Results From 3 Randomized Controlled Trials

Value in Health ◽

10.1016/j.jval.2011.08.042 ◽

2011 ◽

Vol 14 (7) ◽

pp. A239

Author(s):

M. Obradovic ◽

A. Lal ◽

H. Liedgens

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Randomized Controlled

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RANDOMISED CONTROLLED TRIALS OF CHRONIC PAIN IN CHILDREN AND ADOLESCENTS: A SYSTEMATIC REVIEW

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.69 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.66-e1

Author(s):

Rym Boulkedid ◽

Armiya Yousouf Abdou ◽

Emilie Desselas ◽

Marlène Monegat ◽

Corinne Alberti ◽

...

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Randomized Controlled Trials ◽

Children And Adolescents ◽

Methodological Quality ◽

Risk Of Bias ◽

Controlled Trials ◽

Recurrent Pain ◽

Pharmacological Agents ◽

Randomized Controlled

BackgroundApproximately 15 to 30% of children and adolescents suffer from daily pain persistent over more than 3 months and there is evidence supporting that the prevalence of chronic pain is steadily increasing in this population. Chronic pain is known to have a negative impact on children's development and social behaviour, leading often to severe psychological distress and physical disability. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials (RCTs) on pharmacological and non-pharmacological therapies in chronic and recurrent pain in the paediatric population.MethodsWe performed a systematic search of PubMed, Embase and the Cochrane Library up to March 2014. Bibliographies of relevant articles were also hand-searched. We included all RCTs that involved children and adolescents (age 0 to 18 years) and evaluated the use of a pharmacological agent or a non-pharmacological approach in the context of chronic or recurrent pain. The latter was defined as pain persisting for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.ResultsA total of 52 randomized controlled trials were selected and included in the analysis. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 45 (34–57) participants. Almost 50% of the RCTs included both adults and children with a median age at inclusion of 13 years. Non-pharmacological approaches were more commonly tested whereas evaluation of pharmacological agents concerned less than 30% of RCTs. Abdominal pain and headache were the most common types of chronic pain experienced among trial participants. Overall, the methodological quality was poor and did not parallel the number of RCTs that increased over the years. The risk of bias was high or unclear in 70% of the trials.ConclusionsThis is the first systematic review of RCTs conducted to evaluate pharmacological and non-pharmacological therapies in chronic and recurrent pain in children and adolescents. Although, management of pain in adults has significantly improved over the years due to the evaluation of numerous analgesic therapies, our results highlight the existing knowledge gap with regards to children and adolescents. Therapeutic strategies, in particular pharmacological agents, applied to relieve chronic or recurrent pain in children and adolescents are not evaluated through high quality RCTs. The need to improve analgesic therapy in children and adolescents with chronic pain is still unmet. We discuss possible research constraints and challenges related to this fact as well as adequate methodologies to circumvent them.

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