The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Fibromyalgia

Ilker Fatih Sari

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG; Drug: Duloxetine 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05937711

90139838-000-E.61673

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 64 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

PTNS+Duloxetine

Experimental group

Description:

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

Treatment:

Other: Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG

Drug: Duloxetine 30 MG

Duloxetine

Active Comparator group

Description:

Duloxetine 30 mg 1X1 p.o

Treatment:

Drug: Duloxetine 30 MG