Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03263884
Other study ID # N-20170041
Secondary ID
Status Completed
Phase N/A
First received August 24, 2017
Last updated March 2, 2018
Start date August 1, 2017
Est. completion date February 28, 2018

Study information

Verified date March 2018
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Repetitive trancranial magnetic stimulation (rTMS) group
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 group
A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.

Locations

Country Name City State
Denmark Aalborg University Aalborg Nordjylland

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02901561 - Comparison Between 2 Doses of Misoprostol Before Intrauterine Device Phase 2/Phase 3
Completed NCT02905058 - Efficacy of Ketoprofen Before Intrauterine Device Insertion Phase 3
Completed NCT02905045 - Efficacy of Ketoprofen Before Hysterosalpingography Phase 3
Recruiting NCT00773760 - MOR and COMT SNP Polymorphism and Pain N/A
Completed NCT03733015 - Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM N/A
Completed NCT02943135 - Lidocaine In-situ Gel Before Intrauterine Device Insertion Phase 3
Completed NCT04473508 - Erectus Nerve Block for Lumbar Spine Surgery Phase 3
Completed NCT02969902 - Buzzy Distraction During Venipuncture N/A
Enrolling by invitation NCT03184649 - Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection (RCT) Phase 1/Phase 2
Completed NCT02614391 - Tablet Distraction for Pain Control During Venipuncture Phase 3
Recruiting NCT00768014 - fMRI Measurements on Pain Relief Methods in First Stage Labor Pain N/A
Completed NCT04586712 - Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury Phase 2
Not yet recruiting NCT04781777 - Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel . N/A
Recruiting NCT06456177 - Nociception Monitoring During Epidural Analgesia
Recruiting NCT00914498 - The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section N/A
Completed NCT00638274 - Comparison of Loss of Resistance Techniques Phase 2
Recruiting NCT04656821 - Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster Phase 4
Withdrawn NCT01263652 - Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients N/A
Completed NCT01925469 - Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram Phase 4
Completed NCT00580489 - Lifeflight: Fentanyl Versus Morphine N/A