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FibromyalgiaNCT05937711

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

A study testing Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG and Duloxetine 30 MG in people with Fibromyalgia, run by Ilker Fatih Sari at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Fibromyalgia
What is being tested?
Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG and Duloxetine 30 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesTurkey (Türkiye)
Study dates
2 Nov 2020to 23 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Giresun University Faculty of Medicine

    Giresun, 28200

  • Ondokuz Mayıs University Faculty of Medicine

    Samsun, 55139

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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
Being tested
Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG, Duloxetine 30 MG
Keywords
Chronic pain, Electric stimulation therapy, Fibromyalgia, Quality of life, Small fiber neuropathy
Medical subject headings
Fibromyalgia, Chronic Pain, Small Fiber Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MGOther

    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 MGDrug

    Duloxetine 30 mg p.o 1X1 (daily)

Study groups in NCT05937711
Study groupRoleWhat they receive
PTNS+DuloxetineExperimentalPosterior 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
Receives: Other: Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG; Drug: Duloxetine 30 MG
DuloxetineActive comparatorDuloxetine 30 mg 1X1 p.o
Receives: Drug: Duloxetine 30 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At baseline, 4th week and 12th week

  2. 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)

    Measured: At baseline, 4th week and 12th week

Secondary outcomes (2)

  1. 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.

    Measured: At baseline, 4th week and 12th week

  2. 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

    Measured: At baseline, 4th week and 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start2 Nov 2020
  3. Primary completion23 May 2022
  4. Study completion23 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05937711
Sponsor's protocol ID
90139838-000-E.61673
Status last verified
Jun 2023
First submitted
24 Jun 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33024295

  • 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.

    PubMed 30212264

  • 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.

    PubMed 23474848

  • 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.

    PubMed 32804230

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

    PubMed 18164488

  • 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.

    PubMed 23748113

  • 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.

    PubMed 29238215

  • 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.

    PubMed 18028042

  • 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.

    PubMed 37568391

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG and Duloxetine 30 MG in people with Fibromyalgia, run by Ilker Fatih Sari at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12 (time frame: At baseline, 4th week and 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05937711, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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