Pain Clinical Trial
Official title:
Effectiveness of Transcranial and Suboccipital Direct Current Stimulation on Endogenous Pain Modulation System in Healthy Volunteers.
Verified date | March 2020 |
Source | University of Castilla-La Mancha |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized controlled trial, in parallel with cross-control design. Two groups of healthy subjects will be randomly selected to transcranial stimulation group or suboccipital stimulation group. Each group receive in a randomized order a real direct current session and a sham session. The study is based on the hypothesis that the application of direct current sitmulation applied at the suboccipital level produce higher modifications on endogenous pain modulation system than transcranial stimulation.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 40 years. - Healthy volunteers (without neurological injury and no history of pain in the last 6 months). - Ability to perform all clinical test and understand the process of the study, as well as obtaining informed consent. - Tolerance to the application of electrotherapy. Exclusion Criteria: - Previous history of surgical intervention at the cervical level. - Have been treated with an electric current similar to that applied prior to the intervention. - Sensitivity altered in the area of application of the intervention. - No commitment to continuity. - History of neuromuscular disease. - Epilepsy. - Injuries, surgery or pain affecting the upper limb. - Material of osteosynthesis at the cervical level. - Diabetes. - History of cancer. - Cardiovascular disease. - Presence of pacemakers or any other implanted electrical device. - Take medication during the study and in the 7 days prior to the study. - Consumption of narcotic substances during the study and in the 7 days prior to the study. - Presence of tattoos or any other external agent introduced in the treatment and assessment area (hand). - Pregnancy. - Presence of severe and frequent headaches. - Ulcers or scars in the skin at the location of the electrodes |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Nacional de Parapléjicos de Toledo | Toledo |
Lead Sponsor | Collaborator |
---|---|
University of Castilla-La Mancha | Hospital Nacional de Parapléjicos de Toledo, Universidad Rey Juan Carlos |
Spain,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | State-Trait Anxiety Questionnaire (STAI-ES) | We will use the adapted version to the Spanish of the State Scale (STAI-ES) of the "State-Trait Anxiety Questionnaire" (STAI). The STAI is a well-known scale of self-report, comprising two self-assessment subscales that measure two concepts of anxiety: state (S) and trait (T). It is composed of 40 items with 4 possible answers each (score 0 to 3). The total scores for each of the subscales range from 0 to 60 points. Specifically STAI-ES evaluates the anxiety-state in a great variety of situations. | At 0 min | |
Other | Beck Depression Inventory (BDI). | Most commonly used questionnaire at the global and national levels to assess depression. We will use the adaptation to the Spanish of the Beck II depression inventory. It consists of 21 items to measure the affective, cognitive situation and the signs and symptoms of depression during the last two weeks. High scores indicate high levels of depressive symptoms. This inventory has demonstrated excellent psychometric properties | At 0 min | |
Primary | Conditioned Pain Modulation | For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3). | Baseline at 0 min | |
Primary | Change from baseline Conditioned Pain Modulation | For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3). | At 30 min | |
Secondary | Baseline Temporal Summation | For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10). | At 5 min | |
Secondary | Change from baseline Temporal Summation | For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10). | At 35 min | |
Secondary | Baseline Pressure Pain Threshold | To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure. | at 10 min | |
Secondary | Change from baseline Pressure Pain Threshold | To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure. | at 40 min |
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