Pain Relief Clinical Trial
Official title:
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Verified date | March 2018 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 28, 2018 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Healthy men and women - Speak and understand English. Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain relief | Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable) | Change from baseline at 2 weeks | |
Secondary | 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' | Change from baseline at 2 weeks | |
Secondary | Patient-rated Tennis Elbow Evaluation | The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm | Change from baseline at 2 weeks | |
Secondary | Attention network test | This task assesses cognitive function in 3 domains: alerting, orienting, and executive function | Change from baseline at 2 weeks | |
Secondary | Pressure pain thresholds | Pressure applied to the surface of the skin using a handheld algometer. | Change from baseline at 2 weeks | |
Secondary | 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. | Change from baseline at 2 weeks | |
Secondary | EEG recordings | we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT). | Change from baseline at 1 weeks |
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