Precision Medicine for Sng/Pain Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) - second
研究概览
简要总结
Patients have different response to different treatment modalities, and sore/pain medicine is no exception. In our experience, low-level laser (LLL), ultrasound, and prolotherapy can reduce sore /pain through different genetic pathway. Whether the therapeutic effect is controlled by the genetic variants of those sore /pain related genes or not, is still in debate. The aims of this study are (1) To find genetic SNPs which can determine the response of sore /pain treatment modalities. (2) To find possible metabolomics and proteomic markers of sore /pain. (3) To determine the algorithm of precision medicine for sore /pain control via the genetic markers. Investigators will recruit 80 myofascial pain patients from Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Bei-Hu Branch in 2021 and 2022. The participants will receive LLL, ultrasound, and prolotherapy, and the therapeutic effect will be recorded. The blood and urine samples from the first, the second, and the third visits will be analyzed by next generation sequencing, and mass spectrometry to find the possible biomarker in 2023 and 2024. Investigators expect to develop the individualized treatment plan by means of these biomarkers. Hopefully, the results will be widely applied in the field of sore /pain medicine.
详细描述
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the International Association for the Study of Pain (IASP). The musculoskeletal disorders are not only the most common cause of chronic sore/pain, but they also result in significant disability in about 50% of sufferers in the US. Furthermore, since these disorders are the most common cause of severe, long-term pain and disability in the elderly over 65 years. In the practice of pain medicine, the doctors predominantly use multi-modal treatment, including medications, physical agents, and injection, to relieve patients' discomfort.
In the past years, our team had some achievements to justify the search of genetic variants for development of a new sore/pain treatment algorithm.
(1) Analgesia of LLLT is through TRPV1. (2) Analgesia by therapeutic ultrasound is through ASIC3. (3) Dextrose injection decreased chronic muscle pain through ASIC1a. (4) Biomarker for sore/pain in fibromyalgia.
According to the clinical outcome, some patients responded to physical agents well, and some preferred injections. The genetic variants of the above-mentioned genes might be the determining factors of differential therapeutic effects. However, it took about 4-8 weeks for a patient to switch from one treatment option to another one. If investigators can determine the optimal treatment modality by genetic biomarkers, the treatment course and total expanse will decrease a lot.
Investigators hypothesize that the genetic variants of the proposed genes (TRPV1, ASIC1a, ASIC3, Tac1, COMT, TCL1A, POMC, RGS4, ASIC2, ASIC4, TRPA1, NK1R, G2A, GPR4, OGR1, TDAG8, TASK1, TASK2, TASK3, TREK1, P2X2, P2X3, P2X5, TRPV4, KCNK1, NTSR1, NTSR2) could be the prognostic biomarkers of sore /pain treatments. Our specific Aims are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age between 20-100 years old.
- •(2) Diagnosed as myofascial pain syndrome patients and willing to receive treatment (including LLLT, therapeutic ultrasound, and local dextrose injection therapy).
排除标准
- •Those having active infection, malignancy, and hematological diseases were excluded. The patients had received local injection at upper trapezius within 3 months are also excluded.
研究组 & 干预措施
B.prolotherapy group
Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.
干预措施: A.therapeutic ultrasound group (Device)
B.prolotherapy group
Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.
干预措施: B.prolotherapy group (Drug)
A.therapeutic ultrasound group
Group A receives 1 MHz therapeutic ultrasound for 5 min at a frequency of 2-3 times per week at the painful upper trapezius muscle.
干预措施: LASER (Device)
A.therapeutic ultrasound group
Group A receives 1 MHz therapeutic ultrasound for 5 min at a frequency of 2-3 times per week at the painful upper trapezius muscle.
干预措施: A.therapeutic ultrasound group (Device)
A.therapeutic ultrasound group
Group A receives 1 MHz therapeutic ultrasound for 5 min at a frequency of 2-3 times per week at the painful upper trapezius muscle.
干预措施: B.prolotherapy group (Drug)
B.prolotherapy group
Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.
干预措施: LASER (Device)
结局指标
主要结局
Visual Analogue Scale (VAS) - second
时间窗: Change from Baseline Visual Analogue Scale at 2 weeks.
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).
Visual Analogue Scale (VAS) - third
时间窗: Change from Baseline Visual Analogue Scale at 4 weeks (if crossover).
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).
Visual Analogue Scale (VAS) - first
时间窗: Baseline Visual Analogue Scale
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).
次要结局
- SF-36(Baseline, week 2, week 4 (if crossover))
- Myoton-Muscle tone(Baseline, week 2, week 4 (if crossover))
- Myoton- Dynamic stiffness(Baseline, week 2, week 4 (if crossover))
- Pain thresholds(Baseline, week 2, week 4 (if crossover))