The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients With Fibromyalgia: a Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12
研究概览
简要总结
This study aimed to investigate the effectiveness of posterior tibial nerve stimulation (PTNS) in reducing pain, improving quality of life, and decreasing disease severity in patients with fibromyalgia.
详细描述
This prospective, single-blind, randomized controlled trial included female patients newly diagnosed with fibromyalgia who had started duloxetine treatment (30 mg/day). Patients who met the inclusion criteria and agreed to participate in the study were randomized (1:1) into two groups. Group 1 (PTNS+duloxetine) underwent six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition to duloxetine (30 mg/day). Group 2 (duloxetine) received duloxetine only (30 mg/day). Randomization was performed manually, with assignments placed in opaque and sequentially numbered envelopes by off-site researchers who were not involved in patient care or follow-up. Outcome measures were assessed by two investigators who were blinded to each patient's group. The participants and nerve stimulators were not blinded to the group allocation. Patients were briefed to not disclose which group they were in during the assessment process.Patients in the study group received six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition to duloxetine; the controls received duloxetine only. The patients were evaluated three times (at baseline, 1st month, and 3rd month). Pain was evaluated using a numeric rating scale, the short-form McGill Pain Questionnaire, and quality of life with a 36-item Short-Form Health Survey (SF-36). Patient functional status and disease severity were evaluated using the fibromyalgia impact questionnaire (FIQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome measures were assessed by investigators who were blinded to each patient's group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 65 years, newly diagnosed according to the American Rheumatology Association 2016 revised FMS diagnostic criteria
- •Patients who come regularly to sessions for posterior tibial nerve stimulation.
排除标准
- •History of fracture/musculoskeletal surgery in the last 3 years
- •Inflammatory joint disease, or neurological disease/neurological deficit with examination
- •Receiving medical treatment for polyneuropathy
- •Contraindications to PNS (pacemaker, epilepsy, diminished skin sensation in the area to be applied).
研究组 & 干预措施
PTNS+Duloxetine
Posterior tibial nerve stimulation (PTNS), twice weekly, 3-4 days apart + Duloxetine 30 mg 1X1 p.o PTNS was applied using two 50 mm × 50 mm electrode pads per extremity. The live pad was placed superior to and medial to the medial malleolus. The ground pad was placed 5-10 cm proximal to the live pad. The PTNS was applied using biphasic square waves with a frequency of 10 Hz and pulse duration of 200 μs. The amplitude was adjusted to the level that produced painless paresthesia in each patient according to their tolerance. PTNS was applied for 30 minutes
干预措施: Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG (Other)
PTNS+Duloxetine
Posterior tibial nerve stimulation (PTNS), twice weekly, 3-4 days apart + Duloxetine 30 mg 1X1 p.o PTNS was applied using two 50 mm × 50 mm electrode pads per extremity. The live pad was placed superior to and medial to the medial malleolus. The ground pad was placed 5-10 cm proximal to the live pad. The PTNS was applied using biphasic square waves with a frequency of 10 Hz and pulse duration of 200 μs. The amplitude was adjusted to the level that produced painless paresthesia in each patient according to their tolerance. PTNS was applied for 30 minutes
干预措施: Duloxetine 30 MG (Drug)
Duloxetine
Duloxetine 30 mg 1X1 p.o
干预措施: Duloxetine 30 MG (Drug)
结局指标
主要结局
Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12
时间窗: At baseline, 4th week and 12th week
NRS was used to evaluate the patients' general pain at rest and during activity (during activities of daily living). Patients were asked to rate their pain from 0 to 10, with 0 indicating no pain and 10 indicating the most severe pain
Change from baseline in Short-Form McGill Pain Questionnaire at week 4 and 12
时间窗: At baseline, 4th week and 12th week
This questionnaire was used to assess the patients' pain. This questionnaire consisted of 15 descriptive words that evaluated the sensory (11) and affective (4) dimensions of pain. Pain intensity was evaluated as follows: 0=none, 1=mild, 2=moderate, and 3=severe. Three pain scores were obtained: sensory, affective, and total (both sensory and affective). The total present pain intensity index was evaluated using a 6-point Likert rating scale. (0 = no pain, 1 = mild, 2 = discomforting, 3 = distressing, 4 = horrible, and 5 = excruciating)
次要结局
- Change from baseline in The 36-item Short-Form Health Survey at week 4 and 12(At baseline, 4th week and 12th week)
- Change from baseline in Fibromyalgia Impact Questionaire at week 4 and 12(At baseline, 4th week and 12th week)
研究者
Ilker Fatih Sari
Assistant Professor
Giresun University