A Prospective, Open-label Self-controlled Trial to Assess Long-term Changes in Pain and Function with Addition of 5% Dextrose to Local Anesthetic Solutions - the PALPADE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory form (BPI)
研究概览
简要总结
The goal of this single-arm, non-randomized, open-label trial is to determine whether adding a 5% dextrose solution to a local anesthetic can improve outcomes in patients with chronic non-cancer pain.
The main question we aim to answer is whether adding a low-concentration (5%) dextrose solution to local anesthetics increases the effectiveness of trigger point injections and/or peripheral nerve blockade in the treatment of chronic non-cancer pain.
Researchers will compare the outcomes of adding 5% dextrose to the usual local anesthetic solution with the outcomes of using the local anesthetic alone to determine if injection therapy is more effective when dextrose is added.
Participants will:
- Attend their scheduled injection treatments every two (2) weeks for a total of six (6) visits.
- Complete a demographic form at the first visit, and the usual pre-visit questionnaires (the Waiting Room Form and the Brief Pain Inventory (BPI)) at every visit, as well as four (4) weeks after the sixth visit (approximately 16 weeks from the study start date). They will also need to complete two short questionnaires-the Patient Health Questionnaire (PHQ-9) and the Patient Global Impression of Change (PGIC)-at the specified intervals.
- Complete all forms, which will be securely emailed to them.
详细描述
Study Background:
There are many different approaches to treating chronic non-cancer pain, offering potential benefits such as symptom reduction, improved function, and enhanced quality of life. In most cases, conservative and noninvasive treatments are used first, with interventional procedures pursued for more persistent, severe, or disabling symptoms, either for diagnosis or treatment.
Injection treatments are typically considered when functional limitations persist despite physiotherapy, pharmacotherapy, and other non-invasive treatments. Corticosteroid injections into spinal and non-spinal joints, tendons, and ligaments are widely used, but repeated use has been associated with cartilage damage and tissue atrophy. Consequently, there is growing interest in other injectable solutions with potential benefits in pain management, including local anesthetics, dextrose, and platelet-rich plasma (PRP).
Prolotherapy is a non-surgical regenerative injection technique in which dextrose is delivered to tissues with degenerative damage, such as tendon insertions (entheses), joints, ligaments, and surrounding joint spaces. These injections are administered in a series of procedures at regular intervals. While the precise mechanism of action for prolotherapy remains unclear, some evidence suggests that a localized inflammatory cascade leads to collagen deposition and the release of growth factors. The increasing interest in prolotherapy is supported by a growing number of published intervention studies, which back anecdotal reports of its benefits in several painful conditions, with minimal adverse effects.
Dextrose has also been used as a diluent for local anesthetics, as it is soluble and does not cause pain or residual complications over time. Faiz et al. demonstrated that the addition of 5% dextrose to 0.5% bupivacaine provided an earlier onset of sensory block for the median nerve compared to normal saline. Additionally, Topol et al. showed superior effects of 1% lidocaine with 12.5% dextrose over lidocaine alone in adolescents with Osgood-Schlatter disease. While dextrose prolotherapy has been studied in several localized pain conditions, there is a lack of data on its role in generalized myofascial pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women ≥ 18 years old, inclusive.
- •A primary diagnosis of chronic non-cancer pain as determined by their physician.
- •Present chronic pain symptoms of at least 3 months in duration.
- •Currently receiving injection therapy every 1-3 weeks for at least 6 months.
- •English proficiency
排除标准
- •Age less than 18 years
- •Scar or infection at the blockade puncture site
- •Unstable neurologic or psychiatric diagnosis, including schizophrenia, bipolar disorder, substance use disorder, depression or anxiety, dementia or neurodegenerative disorder
- •Serious acute life stressor, clinical illness, or organ disease within the past three months
- •Serious or significant traumatic injury, surgical or dental procedure within the past three months
- •Lack of English proficiency or unable to complete patient forms
- •Denial or withdrawal of consent, as per the informed consent form (ICF).
研究组 & 干预措施
Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice
The physician will add 1 mL of 50% dextrose solution (Pfizer Canada ULS, Kirkland, Québec) to the usual local anesthetic solution of choice for each patient. Solutions contain either 0.3% Ropivacaine, 1% Procaine, 0.5% Lidocaine, 0.25% Bupivacaine, or a mixture of 0.25% Bupivacaine and 2% Lidocaine in a 9:1 ratio.
干预措施: Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient. (Drug)
结局指标
主要结局
Brief Pain Inventory form (BPI)
时间窗: BPI is administered at the following intervals: first visit (Baseline/week 1), the third visit (Week 5), the sixth and final visit (Week 11), and again four weeks after the end of the intervention period (Week 15).
The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.
Patient Health Questionnaire (PHQ-9)
时间窗: The PHQ-9 is administered at the following intervals: At the first visit (Baseline/Week 1), the third visit (Week 5), the sixth and final visit (Week 11), and again four weeks after the end of the intervention period (Week 15).
The PHQ-9 is a depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Visual Analogue Scale (VAS)
时间窗: The VAS is administered at the following intervals: At the first visit (Baseline/Week 1), the third visit (Week 5), the sixth and final visit (Week 11), and again four weeks after the end of the intervention period (Week 15).
VAS consists of a 10 cm horizontal line with the endpoints defining extreme limits such as no pain at all and pain as bad as possible.
Patient's Global Impression of the Change (PGIC)
时间窗: The PGIC is administered at the following intervals: At the end of the intervention (Week 11) and four weeks after the end of the intervention period (Week 15).
The PGIC is a short questionnaire that provides a responsive and interpretable assessment of how a participant evaluates changes in their status.
次要结局
未报告次要终点
研究者
Richard Nahas
Physician/Clinic director/ Principal investigator
The Seekers Centre