Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 6
- 主要终点
- Disability
研究概览
简要总结
The primary objective of the study is to examine whether there is a difference in disability after 12 months of Spinal Cord Stimulation (SCS) in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2) after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation. The secondary objective of the study is to examine whether there is a difference after 12 months of SCS in PSPS T2 patients after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation on pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization, and healthcare expenditure.
详细描述
Persistent Spinal Pain Syndrome Type II (PSPS T2) is a condition in which patients are suffering from persistent low back pain, despite previously performed surgical interventions. One way to help patients to alleviate their pain, is with Spinal Cord Stimulation (SCS). SCS is able to provide pain relief and a decrease in disability but also to decrease the amount of pain medication and more specifically opioid intake. Nevertheless, the number of patients that can eventually totally omit the use of opioids is rather limited.
In this trial, we will investigate the effect of a pain medication tapering program before starting the SCS trajectory as the new treatment strategy for patients implanted with SCS. This allows us to tackle the high burden of patients that are taking a lot of pain medication by proceeding towards a more logical treatment plan for a costly and debilitating condition.
A three-arm multicenter randomized controlled trial will be conducted to evaluate whether there is a difference in disability (primary outcome) after 12 months of SCS in PSPS T2 patients after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation. Two different pain medication tapering programs (standardized versus personalized tapering) will be evaluated in this project. Pain medication tapering will be provided to 130 patients during a hospital stay, compared to 65 patients who do not undergo pain medication tapering before SCS implantation. Besides disability as primary outcome measure, several secondary outcome measurements will be collected namely pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization and health expenditure. Outcome measurements will be collected at baseline, and after 1 month, 3, 6 and 12 months of SCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Both the outcome assessors as well as the investigator (statistician) will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PSPS T2, defined as patients suffering from neuropathic pain of radicular origin with pain in the lower back and/or leg(s), of an intensity of at least 4/10 on the Numeric Rating Scale, for a period of at least 6 months after a minimum of one anatomically successful spinal surgery and being refractory to conservative treatment (according to Belgian reimbursement rules from January 1st, 2018)
- •Patients need to be scheduled for SCS to be eligible for participation in the study
- •Currently taking opioids
- •18 years and older
- •Speaking and reading Dutch or French
排除标准
- •Being actively treated for cancer.
- •Having a life expectancy below 6 months.
- •Receiving intrathecal drug delivery.
- •Patients with contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency).
- •Epilepsy treated by Pregabalin.
- •Currently using benzodiazepines at more than 40 mg diazepam-equivalents per day.
结局指标
主要结局
Disability
时间窗: The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation
Disability, evaluated with the Oswestry Disability Index
次要结局
- Pain intensity(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Health-related Quality of Life(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- General Self-Efficacy(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Pain Catastrophizing(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Coping(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Participation(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Drug related patient characteristics and problems(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Risk for aberrant medication-related behaviour(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Opioid craving(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Medication use(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Healthcare utilization(The change in healthcare utilization starting from the baseline screening up to 12 months after the intervention.)
- Anxiety and depression(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Sleep quality(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
- Symptoms of Central Sensitization(The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation.)
研究者
Moens Maarten
Principal Investigator
Universitair Ziekenhuis Brussel