Clinical trial NCT05937711: The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Fibromyalgia
Official title: The Effect of Transcutaneous Posterior Tibial Nerve Stimulation on Pain and Quality of Life in Patients With Fibromyalgia: a Single-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Chronic pain
Electric stimulation therapy
Fibromyalgia
Quality of life
Small fiber neuropathy
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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).

Primary outcomes:
measure: Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12
timeFrame: At baseline, 4th week and 12th week
measure: Change from baseline in Short-Form McGill Pain Questionnaire at week 4 and 12
timeFrame: At baseline, 4th week and 12th week
Secondary outcomes:
measure: Change from baseline in Fibromyalgia Impact Questionaire at week 4 and 12
timeFrame: At baseline, 4th week and 12th week
measure: Change from baseline in The 36-item Short-Form Health Survey at week 4 and 12
timeFrame: At baseline, 4th week and 12th week
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Faculty of Medicine
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
affiliation: Giresun University Faculty of Medicine, The Department of Physical Medicine and Rehabilitation
name: İlker Fatih Sarı
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.
citation: 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.
citation: 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.
citation: 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.