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Trial record 21 of 33561 for:    Placebo AND placebo effect

Neuromodulation of Placebo Effect on Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT03046017
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Brief Summary:
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: tDCS Other: Lidocaine cream Other: Control cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Neuromodulation of Placebo Effect on Chronic Pain Patients
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: real tDCS
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.

Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).

Other: Control cream
A neutral cream will be applied as a control.

Sham Comparator: sham tDCS
In this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.

Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).

Other: Control cream
A neutral cream will be applied as a control.

control group
In this group, participants will receive tDCS but will only receive a cream on their lower back.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.

Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).

Other: Control cream
A neutral cream will be applied as a control.




Primary Outcome Measures :
  1. fMRI signal changes [ Time Frame: 2 days; Sessions 5 and 7 ]
  2. Gracely Scale pain rating changes [ Time Frame: 2 days; Sessions 2 and 7 ]
  3. resting state functional connectivity changes [ Time Frame: 2 days; Sessions 5 and 7 ]


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteers 21-60 years of age.
  • Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
  • At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
  • At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria:

  • Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
  • Complicated back problems (e.g., prior back surgery, medicolegal issues).
  • The intent to undergo surgery during the time of involvement in the study.
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
  • Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
  • History of medical or psychiatric illness.
  • History of substance / alcohol abuse or dependence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046017


Contacts
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Contact: Georgia Wilson, BA 617-726-5004 gjwilson@mgh.harvard.edu

Locations
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United States, Massachusetts
Martinos Center for Biomedical Imagin Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Jian Kong, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03046017     History of Changes
Other Study ID Numbers: 2015P001440
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action