Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Procedure: repetitive transcranial magnetic stimulation (rTMS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Pre and post test |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immediate and Short-term Effects of Single-session Repetitive Transcranial Magnetic Stimulation on Pain Thresholds In Patients With Chronic Low Back Pain - A Pilot Study |
Actual Study Start Date : | January 19, 2019 |
Estimated Primary Completion Date : | August 31, 2020 |
Estimated Study Completion Date : | August 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Intervention
repetitive transcranial magnetic stimulation
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Procedure: repetitive transcranial magnetic stimulation (rTMS)
A single section of rTMS (2,000 pulses)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon Wang-Price | 2146897715 | swang@twu.edu |
United States, Texas | |
Texas Woman's University | Recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Sharon Wang-Price, PhD 214-689-7715 swang@twu.edu |
Principal Investigator: | Sharon Wang-Price | Texas Woman's University |
Tracking Information | |||||
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First Submitted Date ICMJE | May 30, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | June 4, 2019 | ||||
Actual Study Start Date ICMJE | January 19, 2019 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pain thresholds [ Time Frame: before intervention, immediate after intervention, and one week after intervention ] pressure pain thresholds, cold pain thresholds, and heat pain thresholds, and heat-generated temporal summation using a A Medoc TSA II Neurosensory Analyzer (Medoc ltd., Ramat Yishai, Israel).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Cortical Excitability [ Time Frame: before intervention and immediate after intervention ] 10 supra-threshold motor evoked potentials (MEP) amplitudes recorded from the first interosseous index (FDI) muscle using a transcranial magnetic stimulation machine (Rapid2, Magstim Co., UK)
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of Repetitive Transcranial Magnetic Stimulation on Pain Thresholds in Patients With Chronic Low Back Pain | ||||
Official Title ICMJE | Immediate and Short-term Effects of Single-session Repetitive Transcranial Magnetic Stimulation on Pain Thresholds In Patients With Chronic Low Back Pain - A Pilot Study | ||||
Brief Summary | Chronic low back pain (CLBP) is a common reason for which patients are treated with opioids. Because the misuse of prescription opioids has become a serious problem in the Uinted States, finding effective alternative non-pharmaceutical interventions for chronic pain management has become an urgent matter. A phenomenon termed central sensitization (i.e. mal-adaption of the brain) has been hypothesized to be an underlying mechanism for the development of chronic pain, leading to sensory hypersensitivity to extremal stimuli. Therefore, non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS) may be an effective intervention to regulate brain excitability, thus reducing chronic pain. However, research has shown inconclusive evidence regarding the rTMS effects on chronic pain reduction, partly due to the heterogeneity of participants in studies to date. Therefore, the primary purpose of this study is to investigate the immediate and short-term effects of rTMS on neurosensory changes (i.e., pain thresholds) in patients with CLBP. The secondary purpuse of the study is to explore the relationship between changes of cortical excitability (TMS parameters) and changes of pain thresholds after the rTMS intervention in patients with CLBP. | ||||
Detailed Description |
Research Design A pre- and post-test research design will be used to examine the immediate and one-week carry-over effects of a single-session of rTMS intervention on individuals with CLBP. The primary outcome measures, including PPT, cold pain threshold (CPT), heat pain threshold (HPT), and heat-generated temporal summation (TS), will be collected three times: before the rTMS intervention, immediately after the intervention, and one week after the intervention. Participants Eligible participants are adults 18 years of age or older and who have had LBP for more than 6 months. According to the Centers for Disease Control and Prevention, chronic pain is defined as pain lasts more than 3 months or past the time of normal tissue healing. In order to ensure the development of central sensitization in the investigator's participants, only individuals with LBP for more than 6 months will be enrolled in this study. Participants will be excluded from the study if they have previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis), evidence of red flags (e.g. fracture, infection, tumor, cauda equina syndrome), cancer, neurological disorders, neuropathy, Raynaud's Disease or pregnancy, and inability to maintain the testing and treatment positions (i.e. sitting, supine hook-lying and prone-lying) for 15 minutes at a time. Additional exclusion criteria for the rTMS intervention include: 1) history of significant head trauma, 2) electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip), 3) metal implantation in the head and neck areas, 4) history of seizures or unexplained loss of consciousness, 5) immediate family member with epilepsy, 6) use of seizure threshold lowering medicine, 7) current abuse of alcohol or drugs, and 8) history of psychiatric illness requiring medication controls. Procedure After the participant is enrolled the study, the participant will be asked to complete an intake form, collecting their demographic data (age, gender, height, weight, occupation, hand dominance), past medical history, and questions related to their low back pain (onset, injury mechanism if any, location, duration, type, and nature). In addition, 4 self-reported questionnaires will be collected from all of the participants before the rTMS treatment, including pain intensity determined using the NPRS, disability determined using the Modified Oswestry Low Back Pain Disability Questionnaire quality of life determined by the Patient-Reported Outcomes Measurement Information System® - short form (PROMIS-29), and severity of central sensitization determined by the Central Sensitization Inventory (CSI ). These questionnaires are commonly used in research studies of chronic pain or CLBP.
After the corticospinal excitability assessment, participants will receive 10Hz rTMS delivered to the hot-spot contralateral to the painful side in the form of twenty 10-second pulse trains (a total of 2,000 pulses) with a 50-second inter-train interval. The rTMS will be delivered via an air-filled coil (see figure to the right). The stimulation intensity will be set at 90% of RMT. After the rTMS intervention, the participant's corticospinal excitability will be re-assessed using the single-pulse TMS method as described earlier. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Pre and post test Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Low Back Pain | ||||
Intervention ICMJE | Procedure: repetitive transcranial magnetic stimulation (rTMS)
A single section of rTMS (2,000 pulses)
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Study Arms ICMJE | Experimental: Intervention
repetitive transcranial magnetic stimulation
Intervention: Procedure: repetitive transcranial magnetic stimulation (rTMS)
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 31, 2020 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03973788 | ||||
Other Study ID Numbers ICMJE | 20394 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sharon Wang-Price, Texas Woman's University | ||||
Study Sponsor ICMJE | Texas Woman's University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Texas Woman's University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |