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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05937711
• Other study ID #: 90139838-000-E.61673
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: May 23, 2022

Study information

• Verified date: June 2023
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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)

Drug:
• Duloxetine 30 MG
Duloxetine 30 mg p.o 1X1 (daily)

Locations

Country	Name	City	State
Turkey	Giresun University Faculty of Medicine	Giresun
Turkey	Ondokuz Mayis University Faculty of Medicine	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ilker Fatih Sari

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	At baseline, 4th week and 12th week
Secondary	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	At baseline, 4th week and 12th week