Trial Outcomes & Findings for Efficacy of the Quell Wearable Device for Fibromyalgia (NCT NCT03714425)

Efficacy of the Quell Wearable Device for Fibromyalgia

The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.

The Brief Pain Inventory assesses the severity of pain and its impact on functioning. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10 (0-10), where 0 means no pain and 10 is worst possible pain. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10 (0-10), where 0 means does not interfere and 10 means completely interferes. Lower values represent a better outcome.

The Revised Fibromyalgia Impact Questionnaire (FIQR) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQR has 3 domains: function, overall impact and symptoms. FIQR has 21 individual questions and all questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three domain scores. The total score of the FIQR ranges from 0 to 100. Lower values represent a better outcome.

The Pain Catastrophizing Scale (PCS) instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The total score is computed by summing responses to all 13 items (scale 0-4). PCS total scores range from 0 - 52. The higher the score, the more catastrophizing thoughts are present. Lower values represent a better outcome.

The Pain Disability Index is a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. The total score is a sum of all 7 categories of life activity listed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which people would normally be involved have been totally disrupted or prevented by the pain. The total index ranges from 0 to 70. The higher the index the greater the person's disability due to pain. Lower values represent a better outcome.

The Hospital Anxiety and Depression Scale (HADS) was developed to assess depression and anxiety in patients. Responses are rated on a scale from 0 to 3, with higher scores indicating higher severity. The ratings of the 14 items are summed to yield a total score (0 to 42), or for each subscale separately (0 to 21). 0 to 7 for normal or no anxiety/depression, 8 to 10 for mild, 11 to 14 for moderate, and 12 to 21 for severe anxiety/depression. Lower values represent a better outcome.

Self-report rating "How helpful was the TENS for your fibromyalgia?" 0=not at all helpful, 10=very helpful.