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Trial record 1 of 1 for:    NCT02723175
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The Effects of CBT and tDCS on Fibromyalgia Patients

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ClinicalTrials.gov Identifier: NCT02723175
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 14, 2015
First Posted Date  ICMJE March 30, 2016
Results First Submitted Date  ICMJE May 23, 2018
Results First Posted Date  ICMJE November 28, 2018
Last Update Posted Date November 28, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Baseline Quantitative Sensory Testing (QST) [ Time Frame: Before Treatment ]
    Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
  • Post Baseline Quantitative Sensory Testing (QST) [ Time Frame: One week Post Treatment ]
    After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
Quantitative Sensory Testing [ Time Frame: 1 hour ]
Participants will undergo comprehensive laboratory pain assessment including hot sensory and pain thresholds using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • The Beck Depression Inventory (BDI) at Baseline [ Time Frame: Before Treatment ]
    The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at baseline. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
  • The Beck Anxiety Inventory (BAI) at Baseline [ Time Frame: Before Treatment ]
    The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
  • Brief Pain Inventory-Average Pain at Baseline [ Time Frame: Before Treatment ]
    To assess each participant's average pain at baseline, the Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
  • Percent Change in Average Daily Pain at Treatment Visit 3 [ Time Frame: Treatment Session 3 (week 3) ]
    Participants were asked to rate their pain on average every day from the start of Treatment 1 until Treatment 3. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 1 and treatment 3. The change in average daily pain ratings from treatment 1 to treatment 3 was calculated below. Time points at week 1 and week 3 were included to calculate percent change.
  • Affective Subscale of McGill Pain Questionnaire at Baseline [ Time Frame: Before Treatment ]
    Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores (Sensory and Affective subscales together) is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale awith 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
  • The Short-Form 12 Healthy Survey at Baseline [ Time Frame: Before Treatment ]
    To assess each participant's mental and physical functioning at Baseline, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
  • The Fibromyalgia (FM) Impact Questionnaire at Baseline [ Time Frame: Before Treatment ]
    To assess the impact of fibromyalgia on each participant's function at baseline, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
  • The Beck Depression Inventory (BDI) at 1 Month Follow up [ Time Frame: 1 month follow up ]
    The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at the one month follow up visit. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
  • The Beck Anxiety Inventory (BAI) at 3 Month Follow Up [ Time Frame: 3 Month Follow Up ]
    The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
  • Brief Pain Inventory-Average Pain at 1 Month Follow Up [ Time Frame: 1 Month Follow Up ]
    At the one month follow up visit, The Brief Pain Inventory (BPI)-short form will be administered to assess each participant's pain on average in the past 30 days. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 30 days using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
  • Percent Change in Average Daily Pain at Treatment Visit Six [ Time Frame: Treatment Session 6 (week 6) ]
    Participants were asked to rate their pain on average every day from the start of Treatment 3 until Treatment 6. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 3 and treatment 6. The change in average daily pain ratings from treatment 3 to treatment 6 was calculated below. Time points at week 3, and week 6 were included to calculate percent change.
  • Percent Change in Average Daily Pain at 1 Month Follow Up [ Time Frame: 1 Month Follow Up ]
    Participants were asked to rate their pain on average every day 30 days post treatment 6 (1 month follow up). Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 30 Daily ratings (Post Treatment 6) were averaged and The change in average daily pain ratings from treatment 6 to the 1 month follow up (30 days post completion of treatment visit 6) was calculated below. Time points week 6, and the 1 month follow up were included to calculate percent change.
  • Percent Change in Average Daily Pain at 3 Month Follow Up [ Time Frame: 3 Month Follow Up ]
    Participants were asked to rate their pain on average every day for 60 days, post 1 month follow up visit. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 3 Month Follow Up included 60 Daily Pain ratings (Collected Post 1 Month Follow Up) that were averaged. The change in average daily pain ratings from the 1 month follow up (30 days post completion of treatment visit 6) to the 3 Month Follow Up (60 days post completion of the 1 month follow up visit) was calculated below. Time points 1 month follow up, and 3 month follow up were included to calculate percent change.
  • Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up [ Time Frame: 1 Month Follow Up ]
    Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale of the McGill Pain Questionnaire for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
  • The Short-Form 12 Healthy Survey at 1 Month Follow Up [ Time Frame: 1 Month Follow Up ]
    To assess each participant's mental and physical functioning at the 1 Month Follow Up visit, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
  • The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up [ Time Frame: 1 Month Follow Up ]
    To assess the impact of fibromyalgia on each participant's function at the 1 Month Follow Up visit, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • The Beck Depression Inventory [ Time Frame: 5 mintues ]
    well-researched, brief self-report depression-screening instrument. This instrument will be used for screening purposes in the laboratory study and to characterize depression in the clinical cohort. The BDI scale assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms.
  • The Beck Anxiety Inventory [ Time Frame: 5 minutes ]
    well-researched, brief self-report anxiety-screening instrument. It assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral).
  • The Brief Pain Inventory [ Time Frame: 5 minutes ]
    a self-report questionnaire designed to assess pain intensity and the impact of pain on general functioning, relationships and mood
  • Daily pain diaries [ Time Frame: through study completion, an average of 6 months. ]
    administered via paper and pencil to patients in the clinical pilot Diaries will assess daily (via VAS) average pain, pain at its worst, pain unpleasantness, mood, activity level, and will capture hours of sleep and sleep quality ratings.
  • The Mcgill Pain Questionnaire [ Time Frame: 5 minutes ]
    self-report scale designed to capture the quality and intensity of pain experience. The ratings load onto 4 factors: 1) Sensory, 2) Affective, 3) Evaluative, and 4) Miscellaneous.
  • The Short-Form 12 Healthy Survey [ Time Frame: 5 minutes ]
    used to assess quality of life across the eight QOL domains captured with the measure during the trial.
  • The Fibromyalgia Impact Questionnaire [ Time Frame: 5 minutes ]
    used to assess pain symptoms and functioning specific to FM.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of CBT and tDCS on Fibromyalgia Patients
Official Title  ICMJE The Effects of Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients
Brief Summary Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.
Detailed Description Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Chronic Pain
Intervention  ICMJE Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
Study Arms  ICMJE
  • Experimental: Sham tDCS Stimulation

    30 minutes of the sham transcranial Direct Current Stimulation

    Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

    Intervention: Device: Transcranial Direct Current Stimulation
  • Experimental: Anodal tDCS Stimulation of DLPFC

    30 minutes of the active transcranial Direct Current Stimulation (tDCS)

    Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

    Intervention: Device: Transcranial Direct Current Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
72
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
  2. Between the ages of 21 and 85

Exclusion Criteria:

  1. Other chronic pain conditions
  2. on chronic opioid therapy
  3. history of seizures
  4. are or might be pregnant
  5. metal/electronic implants or devices above the waist
  6. moderate to severe depression (HDRS >19)
  7. moderate to severe anxiety (BAI >16)
  8. Latex allergy
  9. Psychiatric illness other than mild depression or anxiety
  10. on medications that lower seizure threshold
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723175
Other Study ID Numbers  ICMJE Pro00039603
1R21AR066428-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Jeffrey Borckardt, Ph.D. Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP