NCT04003714

Brief Summary

Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after surgery for lumbar disk herniation (LDH). Repetitive transcranial magnetic stimulation (r-TMS) is a technique that allows non-invasive and relatively painless stimulation of cerebral cortex. It can reduce the experience of chronic pain by using magnetic field to produce small electrical currents in the cortex.The aim of this study is to determine the effectiveness of r-TMS treatment on patients with FBSS.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

June 28, 2019

Last Update Submit

February 18, 2020

Conditions

Failed Back Surgery Syndrome

Keywords

repetitive transcranial magnetic stimulationback painfailed back surgery syndrome

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    All groups were evaluated for low back and leg pain with Visual Analogue Scale (VAS) for rest, activity, and sleep-disturbing. Patients were instructed to indicate the severity of pain on a 10- point scale, on which 0 meant no pain, 5 meant moderate pain, and 10 meant intolerable pain.

    4 months

  • Oswestry Disability Index

    Functional status in all groups was evaluated with the Oswestry disability index (ODI). The ODI consists of 10 topics concerning pain, lifting, ability of selfcare, ability to walk, sit, stand and travel, social life, and sleep quality and is intended to assess disability and quality of life related to low back pain. ODI scores range from 0 (no disability) to 100 (maximum disability possible).

    4 months

  • DN-4 Interview Questionnaire

    The DN4-interview questionnaire (0-10) was used to identify neuropathic pain.

    4 months

Secondary Outcomes (2)

  • The Pittsburgh Sleep Quality Index

    4 months

  • Beck Depression Inventory

    4 months

Study Arms (2)

Repetitive Transcranial Magnetic Stimulation Group

EXPERIMENTAL

Patients in r-TMS group received r-TMS 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions.

Device: Repetitive Transcranial Magnetic Stimulation

Sham Group

SHAM COMPARATOR

Control group received sham r-TMS with the same protocol.

Device: Sham Repetitive transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Patients in r-TMS group received 5 Hz of r-TMS. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture).

Repetitive Transcranial Magnetic Stimulation Group
Sham Repetitive transcranial Magnetic StimulationDEVICE

Control group received sham r-TMS.

Sham Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 34-65 years
  • Clinically diagnosed as FBSS
  • History of surgery for LDH with persistent back and leg pain
  • Patients with no root compression in postoperative magnetic resonance imaging of lumbar spine

You may not qualify if:

  • Epilepsy
  • Stroke
  • Head trauma
  • History of intracranial operation
  • Cardiac pacemaker
  • Pregnancy
  • Postoperative lumbar root compression
  • Neurologic deficits
  • Prior physiotherapy for low back pain last 6 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Failed Back Surgery SyndromeBack Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Meryem Yılmaz Kaysın, MD

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 1, 2019

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Patients in r-TMS group received 5 Hz of r-TMS, as a 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions. R-TMS was applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture). Control group received sham r-TMS with the same protocol. Lumbar isometric exercises were given to all patients in both groups. Outcome measures were visual analogue scale (VAS) for rest, activity, and sleep-disturbing; Oswestry disability index; DN4-interview questionnaire; Pittsburgh Sleep Quality Index; Beck Depression Inventory (BDI). All patients were assessed at baseline, 5th session, 10th session, 1st and 3rd months after session.