Ongoing Clinical Trials for Spinal Pain
Currently, there is 1 ongoing clinical trial for patients with spinal pain. This trial is being conducted in Belgium and focuses on helping patients reduce their use of opioid pain medications before undergoing spinal cord stimulation, a treatment designed to manage chronic pain after spinal surgery.
Clinical trial locations
Study on Opioid Detoxification Using Buprenorphine, Naloxone, and Oxycodone for Patients with Persistent Spinal Pain Syndrome Type II
This clinical trial is designed for patients with Persistent Spinal Pain Syndrome Type II, a condition that causes ongoing pain in the lower back and/or legs even after spinal surgery. The study explores different approaches to reducing opioid pain medications before patients undergo spinal cord stimulation, a treatment that uses electrical signals to help manage chronic pain.
Main inclusion criteria:
- Confirmed diagnosis of Persistent Spinal Pain Syndrome Type II with nerve-related pain in the lower back and/or legs
- Pain level of at least 4 out of 10 on a pain scale
- Pain lasting for at least 6 months after at least one successful spinal surgery
- Pain that has not improved with standard treatments
- Scheduled to receive Spinal Cord Stimulation treatment
- Age 18 years or older
- Currently taking opioid pain medications
- Ability to speak and read Dutch or French
Main exclusion criteria:
- Other significant medical conditions that could interfere with the study
- Inability to follow study procedures or attend scheduled visits
- Current participation in another clinical trial
- Recent surgery that could affect study results
- History of substance abuse or addiction
- Pregnancy or planning to become pregnant during the study
- Known allergy to study medications or materials
- Uncontrolled mental health conditions
- Pacemaker or other implanted electronic devices
- Active infection or other conditions that could affect study results
Focus and goal: The trial aims to understand how different approaches to reducing opioid use before spinal cord stimulation can affect overall outcomes for patients. Participants will be divided into three groups: one following a standardized plan to gradually reduce pain medication, another following a personalized plan, and a third group not following any specific reduction plan. The study will observe patients over 12 months to measure changes in their level of disability using the Oswestry Disability Index.
Investigational treatment: The study uses an Opioid Detoxification Protocol, which is a treatment plan designed to help patients gradually and safely reduce their use of opioid pain medications. The medications involved include Suboxone (containing buprenorphine and naloxone in sublingual tablets), OxyNorm Instant (containing oxycodone hydrochloride in orodispersible tablets), and Catapressan (containing clonidine hydrochloride in tablets or injectable solution). Some participants may receive a placebo. The goal is to minimize withdrawal symptoms while helping the body adjust to lower levels of medication.
Summary
There is currently one clinical trial available for patients with spinal pain, specifically focusing on those with Persistent Spinal Pain Syndrome Type II. This trial is being conducted in Belgium and represents an important research effort to optimize pain management strategies for patients who have not found relief after spinal surgery. The study’s focus on opioid reduction before spinal cord stimulation reflects growing awareness of the need for safer pain management approaches and reducing long-term opioid dependency. Patients who meet the eligibility criteria and are scheduled for spinal cord stimulation may wish to discuss participation with their healthcare providers.