SPRC – CLINICAL TRIALS

Sydney Pain Research Centre (SPRC) is the research branch of the Sydney Pain Management Centre. SPRC has a dedicated research team and is involved in many groundbreaking research projects. SPRC is at the forefront of scientific research with a number of national and international clinical trials. SPRC has been involved in a number of first-in-human clinical trials and is proud to be contributing in advancing the science of pain medicine. All our research and clinical trials will go through rigorous human ethics and hospital governance approvals.

We have several current and upcoming clinical trials and we are actively recruiting suitable candidates. If you or someone you know who has been suffering from pain and is looking for the newest treatments for pain you may look up our current clinical trials or contact our offices.

Please contact trials@sydneypaincentre.com for more information or to register your interest.

Completed Trials

Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural

Injection for Radicular Pain (SALIENT) 

This was a 9 month study completed in mid-2022 that aimed to investigate the efficacy of a SX600, a derivative of dexamethasone, delivered via a transforaminal epidural steroid injection for the treatment of chronic back and leg pain over a 9 month period. Pain intensity, quality of life, disability and perception of change were all measured as indicators of change. 

The Sydney Pain Research Centre enrolled the second highest number of participants worldwide, with 13 persons’ receiving the study injection.

Nalu Medical: Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain using the Nalu Neurostimulation System

The aim of this trial was to determine the efficacy and safety of the Nalu Neurostimulation System. The Nalu Neurostimulation System is one of the smallest devices in size. This would alleviate any potential discomfort and pain that may occur at the surgical site whilst delivering adequate pain relief equivalent to other commercially-available stimulators. 

Current Trials

Prospective, Long-Term, Real-world, Practice Audit on OMNIA 10 kHz Spinal Cord Stimulation Therapy in a Cohort of Chronic Pain Patients

This study, sponsored by NEVRO, began in 2021 at the Sydney Pain Research Centre. It aims to continue to investigate the efficacy of the OMNIA Spinal Cord Stimulation device in persns’ with chronic neuropathic pain, on pain reduction, physical function, quality of life and  sleep over a 12 month period. 

Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System (NeuroSense)

The Sydney Pain Research Centre was the first site worldwide to begin the NeuroSense study in late 2021. Dr Mohabbati performed the first permanent Spinal Cord Stimulator implant for the trial in April 2022.

NeuroSense is specialized technology that aims to prevent overstimulation. The device has an accelerometer that detects a change in a person’s activity and/or body position relative to gravity. The device is then able to recognise and automatically switch between programs to prevent overstimulation as a person goes about their daily activities, aiming to improve patient satisfaction with the device and lower overall pain intensity. 

BENEFIT-03 (Biotronik)

Commencing mid-2022, BENEFIT-03 is an extension of research gathered in the BENEFIT-01 and BENEFIT-02 studies. Using a novel, multiphase waveform, the Prospera SCS System with HomeStream Programming aims to:

a) Provide continuous stimulation and prevent occurrence of overstimulation with particular movements
b) Provide real-time insight to daily changes in a persons’ pain intensity and pain location
c) Allow for remote programming to better address a patient’s concerns as they occur in real-time
d) Improve accessibility to the technology for patients who may have difficulty accessing healthcare facilities

GEMINI (Abbott)

The GEMINI clinical trial is a 6 week trial commencing in mid-2022. The GEMINI IPG is one of the smallest devices on the market but aims to improve charging performance and increase battery life. The primary aim of the trial is to ensure efficacy and safety of the product prior to launching commercially. Persons’ eligible for this trial would have a) had a successful spinal cord stimulator trial in the past, or b) require replacement of their current IPG device.

Freshwater (Saluda)

This study commenced in 2021 and is investigating the efficacy of the “Evoke SCS” system for persons with pain of the trunk and either upper or lower extremities. “Evoke” system uses ECAP-controlled closed loop stimulation based a feedback cycle. This helps to adjust the level of stimulation felt as a person goes about their daily activities, with the aim to prevent overstimulation. This has already been proven to be effective in previous research, with this study mainly focusing on safety of the device and consumer feedback and perception of usability in a clinical population. 

Future Trials

A Prospective, Randomized, Controlled, Open Label, Parallel Group Confirmatory Clinical Investigation to Investigate the Safety and Effectiveness of DiscSeal for the Treatment of Low Back Pain caused by Discogenic Disease (including Degenerative Disc Disease (DDD), Internal Disc Disruption (IDD), and/or non-specific discogenic disease) of the Lumbar Spine (SpineOvations)

DiscSeal is an intra-discal augmentation device that has been designed to increase the height of the intervertebral disc in patients diagnosed with discogenic lower back pain. The primary aim of the study is to assess how effective the device is in reducing pain severity. The device is inserted during a procedure called a discography, which is a short day procedure performed in operating theatres under light sedation. This device will be used in patients who have failed first line therapy, such as physiotherapy, medications and steroid injections, and continue to have disabling lower back pain. The device was intended to be a second line of therapy, bridging the gap between conservative management and surgical intervention. 

A Prospective Study using High Frequency (10kHz) Spinal Cord Stimulation in Patients with Chemotherapy-Induced Peripheral Neuropathic Pain 

This is a new, investigator-led study created by the Sydney Pain Management Centre Director, Dr Vahid Mohabbati. The premise for the study was formulated following Dr Mohabbati’s experiences in treating persons’ with chemotherapy-induced neuropathic pain, as he recognised the need for an alternative treatment to conventional pharmacotherapy. Chemotherapy-induced neuropathic pain can affect up to 30% of persons’ after six months of chemotherapy treatment. This study is currently in the draft protocol phase and is being developed in collaboration with oncologists at the SAN Integrated Cancer Centre.