Study on Opioid Detoxification Using Buprenorphine, Naloxone, and Oxycodone for Patients with Persistent Spinal Pain Syndrome Type II

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What is this study about?

This clinical trial is focused on helping patients with , a condition that causes ongoing pain in the lower back and/or legs even after spinal surgery. The study aims to explore different ways to reduce the use of pain medications, specifically opioids, before patients undergo a procedure called spinal cord stimulation (SCS). SCS is a treatment that uses electrical signals to help manage chronic pain.

Participants in the study will be divided into three groups. One group will follow a standardized plan to gradually reduce their pain medication, another group will have a personalized plan, and the third group will not follow any specific plan to reduce medication. The study will observe these patients over a period of 12 months to see if there is a difference in their level of disability, which will be measured using a tool called the Oswestry Disability Index.

The medications involved in this study include (containing buprenorphine and naloxone), (also containing buprenorphine and naloxone), (containing oxycodone hydrochloride), and (containing clonidine hydrochloride). Some participants may receive a placebo. The goal is to understand how different approaches to reducing opioid use before SCS can affect the overall outcome for patients with PSPS T2.

1 initial assessment

Upon joining the clinical trial, an initial assessment will be conducted to confirm eligibility. This involves reviewing your medical history and current condition, specifically focusing on persistent spinal pain syndrome type II.

You will be asked to provide information about your pain levels and any previous treatments you have undergone.

2 medication tapering protocol

Depending on the group you are assigned to, you may undergo a standardized or personalized pain medication tapering protocol, or you may not undergo any tapering protocol before the spinal cord stimulation (SCS) implantation.

If you are in a tapering group, the protocol will involve gradually reducing your opioid medication under medical supervision. The specific medications involved may include Suboxone (sublingual tablets), OxyNorm Instant (orodispersible tablets), and Catapressan (tablets or injectable solution).

3 spinal cord stimulation implantation

After completing the medication tapering protocol, if applicable, you will undergo the spinal cord stimulation (SCS) implantation procedure.

This procedure is designed to help manage your pain by delivering electrical impulses to your spinal cord.

4 follow-up assessments

Following the SCS implantation, you will participate in follow-up assessments at various time points: baseline, 1 month, 3 months, 6 months, and 12 months.

These assessments will evaluate your progress and any changes in your disability levels using the Oswestry Disability Index score.

5 final evaluation

At the end of the 12-month period, a final evaluation will be conducted to assess the overall impact of the treatment on your condition.

The results will help determine the effectiveness of the different medication tapering protocols in conjunction with the SCS treatment.

Who Can Join the Study?

Patients must have been diagnosed with Persistent Spinal Pain Syndrome Type II (PSPS T2), which involves nerve-related pain in the lower back and/or legs.
The pain must be at least 4 out of 10 on a pain scale, where 0 means no pain and 10 means the worst pain possible.
The pain must have lasted for at least 6 months after having at least one successful spinal surgery.
The pain must not have improved with standard treatments.
Patients must be scheduled to receive a treatment called Spinal Cord Stimulation (SCS).
Patients must be 18 years or older.
Patients must be currently taking opioids, which are strong pain-relieving medications.
Patients must be able to speak and read either Dutch or French.
Both men and women can participate in the study.

Who Cannot Join the Study?

Patients with any other significant medical condition that could interfere with the study.
Patients who are unable to follow the study procedures or attend scheduled visits.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery that could affect the study results.
Patients with a history of substance abuse or addiction.
Patients who are pregnant or planning to become pregnant during the study.
Patients with a known allergy to any of the study medications or materials.
Patients who have a mental health condition that is not well controlled.
Patients who have a pacemaker or other implanted electronic device.
Patients who have an infection or other condition that could affect the study results.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Az Maria Middelares Gent	Gent	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Hnwgrsdpqbxtpazkrkxn Lomf	Lier	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	28.06.2023

Trial locations

Investigated drugs:

Opioid Detoxification Protocol is a treatment plan designed to help patients gradually reduce their use of opioid pain medications. This process is important for patients who have been using opioids for a long time and need to stop taking them safely. The goal is to minimize withdrawal symptoms and help the body adjust to lower levels of medication. In this clinical trial, patients with persistent spinal pain syndrome type II, who are being treated with spinal cord stimulation, will follow a specific plan to taper off their pain medications. This can be done using a standardized protocol, which is the same for everyone, or a personalized protocol, which is tailored to each patient’s needs. The study aims to see how these different approaches affect the patients’ disability levels after 12 months.

Investigated diseases:

Back pain

Persistent Spinal Pain Syndrome Type II (PSPS T2) – This condition is characterized by chronic pain that persists in the spine after surgical intervention, typically following spinal surgery. The pain is often localized to the area of the spine that was operated on, but it can also radiate to other parts of the body. Over time, the pain may become more intense and can lead to significant discomfort and disability. Patients may experience a combination of back pain, leg pain, or both, which can affect their daily activities and quality of life. The progression of the syndrome can vary, with some individuals experiencing stable symptoms while others may notice worsening pain over time. The condition is often associated with changes in the nervous system that contribute to the persistence of pain.

Trial ID:

2024-516647-79-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Opioid Detoxification Using Buprenorphine, Naloxone, and Oxycodone for Patients with Persistent Spinal Pain Syndrome Type II

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?