Ultrasound-guided Pulsed Radiofrequency Versus Dry Needling for Pain Management in Chronic Neck and Shoulder Myofascial Pain Patients at a Tertiary Hospital in China: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Pain VAS score
研究概览
简要总结
Myofascial pain (MPS) is the leading cause of chronic and persistent regional pain, affecting as many as 85% of the general population. A variety of treatment methods for myofascial pain have been investigated, including injection of saline, local anesthetics and steroids, dry needle, mini-scalpel, rich platelet plasma and radiofrequency ablation. Ultrasound guided dry needle (DN) and pulsed radiofrequency ablation (PRF) of the trigger point have been considered as two effective and promising treatments for myofascial pain. As far as searched, we failed to identify any study comparing the effects of DN and PRF in myofascial pain patients.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years old.
- •Chronic (>3 months) myofascial pain in the neck, shoulder, and upper back region.
- •Myofascial pain will be diagnosed based on Simons and Travell's criteria: taut band palpable, exquisite spot tenderness of a nodule in a taut band, patient's recognition of current pain complaint by pressure on the tender nodule, and painful limit to full stretch range of motion.
- •Have at least a pain VAS score of 40 mm; thus, a minimal clinically significant change is detectable.
排除标准
- •History of receiving DN or PRF treatment or currently undergoing other pain-related treatments (acupuncture, laser, infrared therapy, etc.).
- •Presence or history of trauma, surgery, or infection in the pain region.
- •Current or history of taking moderate to strong analgesics, such as tramadol and morphine.
- •Severe systemic disease (eg. severe hepatic or renal dysfunction), coagulopathy, or medications affecting the coagulation system.
- •Allergy to medications used.
- •Pregnancy, psychiatric disease, medical background, inability to cooperate, or refusal to participate.
- •Withdrawn Criteria:
- •Unwilling to continue participation or unable to follow the treatment plan.
- •Unable to obtain the primary outcome data due to any reason.
结局指标
主要结局
Pain VAS score
时间窗: Postoperative six months
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
次要结局
- Pain VAS score(postoperaitve day 0 and postoperative 1 and 3 months)
- Sleep status(postoperaitve day 0 and postoperative 1, 3 and 6 months)
- PHQ9(postoperaitve day 0 and postoperative 1, 3 and 6 months)
- NDI(postoperaitve day 0 and postoperative 1, 3 and 6 months)
- GAD7(postoperaitve day 0 and postoperative 1, 3 and 6 months)
- SF36(postoperaitve day 0 and postoperative 1, 3 and 6 months)
- Mechanical pain threshold(postoperaitve day 0 and postoperative 1, 3 and 6 months)
研究者
Jin Wang
Doctor
Peking Union Medical College Hospital