Pain ReliefNCT03263884
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
A study testing Repetitive trancranial magnetic stimulation (rTMS) group in people with Pain Relief, run by Aalborg University at 1 site in Denmark.
Trial summary
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Relief
- What is being tested?
- Repetitive trancranial magnetic stimulation (rTMS) group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 28 Feb 2018
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Speak and understand English.
Who cannot join
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Previous experience with rTMS
- Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.
Read the detailed description
This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).
- Conditions
- Pain Relief
- Being tested
- Repetitive trancranial magnetic stimulation (rTMS) group, Sham group
- Keywords
- nerve growth factor, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive trancranial magnetic stimulation (rTMS) groupDevice
Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Sham groupDevice
A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real treatment group | Experimental | Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.
The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses. Receives: Device: Repetitive trancranial magnetic stimulation (rTMS) group |
| Sham treatment group | Sham comparator | Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation Receives: Device: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Measured: Change from baseline at 2 weeks
Secondary outcomes (6)
Muscle soreness
7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'
Measured: Change from baseline at 2 weeks
Patient-rated Tennis Elbow Evaluation
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Measured: Change from baseline at 2 weeks
Attention network test
This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
Measured: Change from baseline at 2 weeks
Pressure pain thresholds
Pressure applied to the surface of the skin using a handheld algometer.
Measured: Change from baseline at 2 weeks
Cuff pressure algometry
The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.
Measured: Change from baseline at 2 weeks
EEG recordings
we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
Measured: Change from baseline at 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Nov 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
- Investigators
- Enrico De Martino, MD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263884
- Sponsor's protocol ID
- N-20170041
- Status last verified
- Mar 2018
- First submitted
- 24 Aug 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
- ClinicalTrials.gov ID
- NCT03263884
- Acronym / sponsor ID
- N-20170041
- Conditions
- Pain Relief
- Keywords
- nerve growth factor, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.
Detailed description
This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real treatment group | Experimental | Device: Repetitive trancranial magnetic stimulation (rTMS) groupTranscranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction. The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses. |
| Sham treatment group | Sham comparator | Device: Sham groupSham coil is used to mimic the clicking sound of the TMS coil and skin stimulation |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Speak and understand English.
Key exclusion criteria (8 listed)
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- History of chronic pain or current acute pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive trancranial magnetic stimulation (rTMS) groupRepetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses. | Device | Real treatment group |
| Sham groupA sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation. | Device | Sham treatment group |
Primary outcome
Pain relief
Time frame: Change from baseline at 2 weeks
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
6 secondary outcomes
Muscle soreness
Time frame: Change from baseline at 2 weeks
Patient-rated Tennis Elbow Evaluation
Time frame: Change from baseline at 2 weeks
Attention network test
Time frame: Change from baseline at 2 weeks
Pressure pain thresholds
Time frame: Change from baseline at 2 weeks
Cuff pressure algometry
Time frame: Change from baseline at 2 weeks
EEG recordings
Time frame: Change from baseline at 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Pain Relief
Recruiting
Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis
Cryoneurolysis, Bipolar Radiofrequency Ablation
RecruitingPhase 4
Comparison Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block
Post Operative Pain Relief After Thyroidectomy
Not yet recruiting
Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection
Overactive Bladder (OAB), Botulinum Toxin Injection
Not yet recruiting
PBM Patch for Postoperative Pain Relief After Urological Surgery
Urological Surgery, Photobiomodulation (PBM)
Recruiting
Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain
Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico De Martino, MD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive trancranial magnetic stimulation (rTMS) group in people with Pain Relief, run by Aalborg University at 1 site in Denmark.
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 8 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 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?
Pain relief (time frame: Change from baseline at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.