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

NCT ID: NCT05937711

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-05-23

Brief Summary

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.

Detailed 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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG

Intervention Type: OTHER

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

Intervention Type: DRUG

Duloxetine 30 mg p.o 1X1 (daily)

Duloxetine

Duloxetine 30 mg 1X1 p.o

Group Type: ACTIVE_COMPARATOR

Duloxetine 30 MG

Intervention Type: DRUG

Duloxetine 30 mg p.o 1X1 (daily)

Interventions

Transcutaneous Posterior Tibial Nerve Stimulation + 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)

Intervention Type: OTHER

Duloxetine 30 MG

Duloxetine 30 mg p.o 1X1 (daily)

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ilker Fatih Sari

OTHER

Sponsor Role: lead

Responsible Party

Ilker Fatih Sari

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

İlker Fatih Sarı

Role: PRINCIPAL_INVESTIGATOR

Giresun University Faculty of Medicine, The Department of Physical Medicine and Rehabilitation

Locations

Giresun University Faculty of Medicine

Giresun, , Turkey (Türkiye)

Ondokuz Mayıs University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 37568391 (View on PubMed)

Other Identifiers

90139838-000-E.61673

Identifier Type: -

Identifier Source: org_study_id