Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain severity
研究概览
简要总结
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.
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
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle).
- •Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months).
- •Age: 19 to 50 years
排除标准
- •Rheumatoid arthritis
- •Fibromyalgia
- •Previous surgery on the affected areas
- •Prior experience with acupuncture
- •Primary radiculopathy
- •Current use of psychotropic drugs (ilicits
- •) Habitual use of anti-inflammatory steroids.
研究组 & 干预措施
Placebo-sham
Placebo-sham twice a week during four weeks
干预措施: DIMMST (Procedure)
Lidocaine injection
Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point. Twice a week during four weeks
干预措施: DIMMST (Procedure)
DIMMST
DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR).
Twice a week during four weeks
干预措施: DIMMST (Procedure)
结局指标
主要结局
Pain severity
时间窗: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
a) The intensity of pain was measured by a 10-cm VAS \[30\]. VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).
Pain threshold
时间窗: A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
Pain pressure threshold (PPT)
次要结局
- Sleep quality - how did you feel when you woke up(A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session))
- Sleep quality - compared to your habitual sleep(A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session))
- Sleep quality -last night(A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session))
研究者
Wolnei Caumo
MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab
Hospital de Clinicas de Porto Alegre