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Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression – Lumbar Spinal Stenosis

The article discusses the challenges and strategies involved in conducting a placebo-controlled trial for surgical treatments. Specifically, it focuses on the SUcceSS trial, which is the first placebo-controlled trial for lumbar decompression surgery for symptomatic lumbar canal stenosis. The study highlights the common issues faced during the implementation of randomized placebo-controlled surgery trials, particularly during the COVID-19 pandemic. The article emphasizes the importance of involving key stakeholders early on in the trial design phase to increase willingness of clinicians and patients to participate. It also suggests that additional resources such as budget and staff time are crucial for the successful operation of such trials. Furthermore, factors like placebo fidelity, timing of randomization, and surgical procedure nuances should be carefully considered. The findings and lessons learned from the SUcceSS trial can significantly benefit researchers in designing and implementing future trials of this nature

Summarised by Mr Mo Akmal – Lead Spinal Surgeon
The London Spine Unit : most established day surgery unit in the world

Published article

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19…

Lumbar Decompression Surgery Expert. Best Spinal Surgeon UK
Trials. 2023 Dec 6;24(1):794. doi: 10.1186/s13063-023-07772-5.ABSTRACTAlthough placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has,

Trials. 2023 Dec 6;24(1):794. doi: 10.1186/s13063-023-07772-5.

ABSTRACT

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.

PMID:38057932 | DOI:10.1186/s13063-023-07772-5

The London Spine Unit : most established day surgery unit in the world

Read the original publication:

Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression

Sciatica My mother was in absolute agony for more than 3 months due to sciatica. It just came out of nowhere and took her out of action. From working full time she went straight to being bed bound and unable to carry out simplest of actions.The pain was 9/10 and she was bed bound for those three months. Multiple trips to A&E and GP and they wouldn't class it as an emergency therefore they wouldn't do anything about it other than upgrading the painkillers which did next to nothing for my mother. I couldn't bear to watch my mother sleeping on A&E bench in pain for 7 hours, just to be told by doctors that she wouldn't be kept in. I remember her joining her hands and begging the doctors to stop the pain which broke my heart. I then started doing research on google and London spine unit came up with Dr Mo AKMAL's profile and review. First meeting with Dr AKMAL was via ZOOM as my mother was bed bound. Dr AKMAL spoke to me and my mom and told us that this is nothing to worry about and that the pain would be 100% gone.Dr AKMAL assured us to visit the hospital so he could physically inspect my mother and give us the best solution. One trip to the london spine unit and Dr AKMAL advised us that the best solution would be to carry out Minimally invasive disectomy. Dr AKMAL advised that due to my mother being bed bound for a while, steroid injection might not give the result that my mother wishes. Dr AKMAL was very confident and showed us some videos from other patients who had gone through the same ordeal. The biggest thing i noticed between before and after was the smile on the patients face. Dr AKMAL was constantly assuring my mother throughout the meeting that he would take care of her pain and gave her 100% confidence that the result would be delivered.He promised her that she would be walking pain free the same day after the operation. Before the operation Dr GURUNG was consulted multiple times and he also was very helpful. Right after the surgery, as Dr AKMAL promised, my mother was walking and the biggest thing was that the pain was gone. My mother had forgotten to smile for three months and there i saw her smiling again. Dr AKMAL and Dr GURUNG gave us brilliant aftercare and informed us that just give them a ring if there was any issue. Its been several weeks now and my mother is heading towards complete recovery without any issues. The pain is completely gone and anyone who is reading this going through the same horrible sciatica pain you must come and see Dr AKMAL. Thank you Dr AKMAL and your whole team for helping my mom achieve this pain free life.

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Trials. 2023 Dec 6;24(1):794. doi: 10.1186/s13063-023-07772-5.ABSTRACTAlthough placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has

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