Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAfyonkarahisar Health Sciences University
About this trial
The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, uncontrolled hypertension,arrhythmia, pacemaker)
Neurodegenerative disease
Epilepsy
History of antiepileptic drug use
Trial design
Design model
Parallel
Treatments tested in this trial
High-frequency real-time rTMS DLPF cortex protocol
DeviceIt was planned to apply the dorsolateral prefrontal cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
High-frequency real-time rTMS M1 motor cortex protocol
DeviceIt was planned to apply the M1 motor cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
Sham rTMS Protocol
DeviceIt was planned to apply the daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: First GroupExperimental treatment 1 intervention
Group B: Second GroupExperimental treatment 1 intervention
Group C: Third GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months.
The Brief Pain Inventory Short Form (SPI-SF) is designed to examine pain in terms of sensory (pain intensity) and impact on daily functioning. The BPI-SF consists of two parts. The first part assesses the severity of worst, mildest, average and momentary pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates "no pain at all" and a response of 10 indicates "the most severe pain imaginable". The second part consists of seven questions assessing how much pain affects daily functioning, including general activity and enjoyment of life. A response of 0 indicates "not at all affected" and a response of 10 indicates "completely affected". The total score ranges from 0-70. Higher scores indicate worsening symptoms.
Time frame
To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.Secondary outcomes
1
Change from baseline International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version at 1. and 2 months.
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool. All variables are rated on a scale ranging from 0 (no pain at all) to 10(the most severe pain imaginable).Higher scores indicate higher pain intensity.
Time frame
To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.2
Change from baseline Quality of Life Index Spinal Cord Injury version (QLI-SCI) at 1. and 2 months.
Quality of life and satisfaction with aspects of quality of life will be assessed using the QLI-SCI instrument. This questionnaire focuses on the categories of health and functioning, social and economic, psychological/spiritual, and family. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10(completely satisfied) with a total of 40 points. Higher scores indicates better quality of life.
Time frame
To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.3
Change from baseline Pain Catastrophizing Scale (PCS) at 1. and 2 months.
Pain experience will be assessed using the PCS. Participants are asked to rate how much they agree with the listed thoughts and feelings they may have when experiencing pain from 0 (not at all) to 4 (all the time). The total score ranges from 0-52. Higher scores indicate increase level of catastrophizing.
Time frame
To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.4
Change from baseline Beck Depression Inventory (BDI) Scores at 1. and 2 months.
Validated measure of clinical depression symptoms to quantify and track mood over time. Scores index depression severity and range from 0-63: 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.Total score is 63. Higher scores indicates depressive mood.
Time frame
To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.Sponsors and contacts
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Source ClinicalTrials.gov