Randomized, Comparative-effectiveness Study of Intradiscal Autologous Bone Marrow Concentrate Versus Intradiscal Corticosteroid for Chronic Discogenic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Mean change in average low back pain score on 0-10 numerical rating scale
研究概览
简要总结
This is a randomized, comparative-effectiveness study comparing intradiscal autologous stem cells (from bone marrow aspirate) to intradiscal corticosteroid for the treatment of chronic discogenic low back pain (LBP). The primary objective of this study is to determine whether intradiscal autologous stem cells (from bone marrow aspirate) is more effective than intradiscal steroids for the treatment of chronic discogenic low back pain (LBP). Participants in this study will be randomized to receive up to intradiscal stem cell injections at 1 or 2 discs with cells harvested from a bone marrow aspirate drawn from participants' iliac crest, or an equal volume (2 mL) of intradiscal steroids and local anesthetic injected into the discs. In order to identify the painful disc(s), discography may be used at the discretion of the provider. Both treatments are frequently used as part of clinical care (i.e. there is no placebo group).
详细描述
In this study, the investigators are attempting to determine if intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BMC) will decrease pain and improve function compared with intradiscal steroids.
Up to 106 patients with a clinical diagnosis of chronic discogenic low back pain for greater than 6 months, MRI evidence of lumbar disc degeneration limited to one or two discs with <50% disc height loss, and positive provocative discography (if clinically indicated) will be randomized to receive intradiscal BMC or steroid and long-acting local anesthetic (bupivacaine).
Those randomized to group I will receive a 2 mL intradiscal injection of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium, while those randomized to group II will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine. The first follow-up will occur at 4-weeks post-treatment at which time rescue medications may be prescribed or adjusted but no other analgesic interventions should occur. The primary outcome measure will be pain relief at 3 months post-treatment, while a positive categorical outcome will be a 2-point or greater decrease in average LBP coupled with either a score > 5/7 on the PGIC (indicating noticeable improvement) or a 10-point decrease in ODI (indicating a clinically meaningful benefit). At 3 months, a repeat MRI will be obtained in selected patients at military treatment facilities (i.e. every 5th patient). Those who fail to experience a positive categorical outcome will be withdrawn from the study to receive alternate care, including an option for intradiscal BMC in those who received corticosteroid. For those who continue to experience a positive outcome, there will be 6- and 12-month follow up visits. At all follow-up visits, histories and physical exams will be performed and questionnaires assessing sleep, function, and anxiety and depression will be administered.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain duration > 6 months
- •Failure of non-operative treatment > 3 months
- •Average pain score > 4/10 over the past week
- •Presumed clinical diagnosis of discogenic low back pain (such as back>leg pain, no or minimal radiation of pain past knee level, no significant improvement with epidural steroid injection, facet injections, sacroiliac joint injections and/or trigger point injections
- •Lumbar MRI within the last 18 months showing disc degeneration in <= 2 lumbar discs; <50% disc height loss in each disc
- •Patient agrees to have disc injection(s) and no other low back interventional or pharmacological treatments for at least 3 months
- •Patient agrees to be off all NSAIDs and corticosteroids from 2 weeks prior to and 3 months after the injection.
- •Stable dose of analgesic medications for at least 2 weeks
排除标准
- •Previous disc directed therapy involving heat (e.g. Intradiscal electrothermal therapy (IDET), biacuplasty)
- •Previous disc injection therapy in the last 3 months (e.g. corticosteroid, platelet rich plasma, stem cells)
- •Previous lumbar spine surgery (e.g. discectomy, fusion) at the affected levels (i.e. those with relief after surgery in whom adjacent segment discogenic pain is suspected can be considered on a case-by-case basis)
- •Disc extrusion or symptomatic disc protrusion at affected level
- •Untreated coagulopathy
- •Allergy to contrast dye or local anesthetics
- •Negative discography or discography showing > 2 positive discs
- •Pain > 15 years in duration
- •Opioid dose > 30 mg oral morphine equivalents per day (patients may be tapered down or off opioids)
- •Diffuse pain phenotype (e.g. diagnosis of fibromyalgia)
- •Secondary gain (e.g. ongoing medical board or litigation related to injury)
- •Pregnancy (study subject report of negative pregnancy status will be sufficient to participate. Testing will be provided if subject is unsure or requests a test to confirm.
- •Cannot read or understand English
研究组 & 干预措施
Intradiscal autologous stem cells
Participants in this arm will have autologous stem cells harvested through bone marrow aspiration. The stem cells that were harvested will be processed and injected into affected intradiscal spaces in the lumber spine.
干预措施: Autologous stem cells (Other)
Intradiscal corticosteroid and local anesthetic
Participants in this arm will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine into affected intradiscal spaces in the lumber spine.
干预措施: Corticosteroid (Drug)
Intradiscal corticosteroid and local anesthetic
Participants in this arm will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine into affected intradiscal spaces in the lumber spine.
干预措施: Local anesthetic (Drug)
结局指标
主要结局
Mean change in average low back pain score on 0-10 numerical rating scale
时间窗: Baseline and 3 months
Mean change in average low back pain score over the past week at 3 months compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)
次要结局
- Hospital Anxiety and Depression Scale score(1 year)
- Athens Insomnia Scale score(1 year)
- Patient global impression of change (PGIC) score(1 year)
- Oswestry disability index score(1 year)
- Mean change in worst low back pain score on 0-10 numerical rating scale(Baseline and 1 year)
- Worst low back pain score on 0-10 numerical rating scale(12 months)
- Positive categorical outcome(12 months)
- Disc Degeneration based on MRI(3 months)
- Average low back pain score on 0-10 numerical rating scale(1 year)