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

NCT05937711 | Completed

• 1 other identifier: 90139838-000-E.61673
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia

Keywords

Chronic pain; Electric stimulation therapy; Fibromyalgia; Quality of life; Small fiber neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  At baseline, 4th week and 12th week

Secondary Outcomes (2)

• Change from baseline in Fibromyalgia Impact Questionaire at week 4 and 12

  At baseline, 4th week and 12th week

• Change from baseline in The 36-item Short-Form Health Survey at week 4 and 12

  At baseline, 4th week and 12th week

Study Arms (2)

PTNS+Duloxetine

EXPERIMENTAL

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

ACTIVE COMPARATOR

Duloxetine 30 mg 1X1 p.o

Drug: Duloxetine 30 MG

Interventions

Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG 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)

PTNS+Duloxetine

Duloxetine 30 MG DRUG

Duloxetine 30 mg p.o 1X1 (daily)

Duloxetine; PTNS+Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Since fibromyalgia is more common in women, female patients were included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ilker Fatih Sari: lead

Study Sites (2)

Giresun University Faculty of Medicine

Giresun, 28200, Turkey (Türkiye)

Location

Ondokuz Mayıs University Faculty of Medicine

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (9)

• Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.

  PMID: 33024295 BACKGROUND

• Cheng CW, Wong CS, Hui GK, Chung EK, Wong SH. Fibromyalgia: is it a neuropathic pain? Pain Manag. 2018 Sep 1;8(5):377-388. doi: 10.2217/pmt-2018-0024. Epub 2018 Sep 13.

  PMID: 30212264 BACKGROUND

• Uceyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, Casanova-Molla J, Reiners K, Sommer C. Small fibre pathology in patients with fibromyalgia syndrome. Brain. 2013 Jun;136(Pt 6):1857-67. doi: 10.1093/brain/awt053. Epub 2013 Mar 9.

  PMID: 23474848 BACKGROUND

• Lin T, Gargya A, Singh H, Sivanesan E, Gulati A. Mechanism of Peripheral Nerve Stimulation in Chronic Pain. Pain Med. 2020 Aug 1;21(Suppl 1):S6-S12. doi: 10.1093/pm/pnaa164.

  PMID: 32804230 BACKGROUND

• Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.

  PMID: 18164488 BACKGROUND

• Oaklander AL, Herzog ZD, Downs HM, Klein MM. Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. Pain. 2013 Nov;154(11):2310-2316. doi: 10.1016/j.pain.2013.06.001. Epub 2013 Jun 5.

  PMID: 23748113 BACKGROUND

• Dabby R, Sadeh M, Goldberg I, Finkelshtein V. Electrical stimulation of the posterior tibial nerve reduces neuropathic pain in patients with polyneuropathy. J Pain Res. 2017 Nov 29;10:2717-2723. doi: 10.2147/JPR.S137420. eCollection 2017.

  PMID: 29238215 BACKGROUND

• Thimineur M, De Ridder D. C2 area neurostimulation: a surgical treatment for fibromyalgia. Pain Med. 2007 Nov-Dec;8(8):639-46. doi: 10.1111/j.1526-4637.2007.00365.x.

  PMID: 18028042 BACKGROUND

• Sari IF, Ilhanli I, Mizrak T, Kulakli F, Kasap Z. The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients with Fibromyalgia: A Single-Blind, Randomized Controlled Trial. J Clin Med. 2023 Jul 29;12(15):4989. doi: 10.3390/jcm12154989.

  PMID: 37568391 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Small Fiber Neuropathy

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• İlker Fatih Sarı

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures were assessed by investigators who were blinded to each patient's group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 10, 2023
• Study Start: November 2, 2020
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)