Trial Outcomes & Findings for The Effects of CBT and tDCS on Fibromyalgia Patients (NCT NCT02723175)

The Effects of CBT and tDCS on Fibromyalgia Patients

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.

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.

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) 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.

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.

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.

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.

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.

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) 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) 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.

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.

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.

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.

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.

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.

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.

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.