An interventional study of Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG and Duloxetine 30 MG in Fibromyalgia, sponsored by Ilker Fatih Sari. Completed at 2 sites in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Ilker Fatih Sari · Not applicable, Interventional, and Other
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.
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).
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →This is the only study on the registry with Ilker Fatih Sari as lead sponsor.
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Exclusion Criteria:
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
Other: Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG · Drug: Duloxetine 30 MG
Duloxetine 30 mg 1X1 p.o
Drug: Duloxetine 30 MG
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 Duloxetine 30 mg p.o 1X1 (daily)
Duloxetine 30 mg p.o 1X1 (daily)
Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12
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
Time frame: At baseline, 4th week and 12th week
Change from baseline in Short-Form McGill Pain Questionnaire at week 4 and 12
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)
Time frame: At baseline, 4th week and 12th week
Change from baseline in Fibromyalgia Impact Questionaire at week 4 and 12
This questionnaire consists of 20 questions evaluating physical function, job status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being of patients with fibromyalgia. It was scored between 0 and 100. High scores indicate high disease severity and low functional status.
Time frame: At baseline, 4th week and 12th week
Change from baseline in The 36-item Short-Form Health Survey at week 4 and 12
This scale is commonly used to evaluate the quality of life. It consists of eight subscales (physical function, physical role limitation, pain, general health, vitality, social function, social role limitation, and mental health) and a total of 36 items. Each subscale was scored between 0 and 100, with 100 points indicating the best health condition and 0 points indicating the worst health condition
Time frame: At baseline, 4th week and 12th week
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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