Cannabis Oil for Chronic Non-Cancer Pain Treatment

Pain Severity Score

Decrease in Pain Severity Score measured by composite of 4 pain items (worst, least, average, now with 0=No Pain and 10=Pain as bad as you can imagine) (mean severity score) from the Brief Pain Inventory

Time frame: Baseline, week 4, 8, 12 and 16

Pain Intensity Score

Improved Pain Intensity Score measured by mean of 7 severity items (general, activity, walking, work, mood, enjoyment of life, relations with others and sleep with 0=No Pain and 10=Pain as bad as you can imagine) from the Brief Pain Inventory

Time frame: Baseline, week 4, 8, 12 and 16

Physical Functioning Score

Increase in Physical Functioning Score measured by the SF-36V2. 10 items in this scale represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling or stooping and walking moderate distances. One self-care item is included to represent limitations in self-care activities. This scale captures both the presence and existent of physical limitations using a three-level response continuum. Low scores indicate significant limitations in performing physical activities, while high scores reflect little or no such limitations.

Time frame: Baseline, week 4, 8, 12 and 16

Mental Health Score

Increase in Mental Health (MH) Score measured by the SF-36V2. This 5-item scale includes one or more items from each of four major mental health dimensions (anxiety, depression, loss of behavioral/emotional control, and psychological wellbeing). Low scores on MH are indicative of frequent feelings of nervousness and depression, while high scores indicate feelings of peace, happiness, and calm all or most of the time.

Time frame: Baseline, week 4, 8, 12 and 16

Social Functioning Score

Increase in Social Functioning (SF) Score measured by the SF-36V2. This 2-item scale assesses health-related effects on quantity and quality of social activities, asking specifically either physical or emotional problems on social activities. The degree to which physical and emotional problems interfere with normal social actives increases with decreasing SF scores. The lowest score is related to extreme or frequent interference with normal social actives due to physical and emotional problems; the highest score indicates that the individual performs normal social activities without interference from physical or emotional problems..

Time frame: Baseline, week 4, 8, 12 and 16

Physical Health-related Role Limitations

Decrease in Physical Health-related Role Limitations measured by the SF-36V2. This 4-item scale covers an array of physical health-related role limitations, including a) limitations in the kind of work or other usual activities, b) reduction in the amount of time spend on work or other usual activities, c) difficulty performing work or other usual activities, and d) accomplishing less. Low scores on this scale reflect problems with work or other actives as a result of physical problems. High scores indicate little or no problems with work or other daily activities.

Time frame: Baseline, week 4, 8, 12 and 16

Depression Score

Improvement in Depression score measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 depression severity is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

Time frame: Baseline, week 4, 8, 12 and 16

Anxiety Score

Improvement in Depression score measured by the Generalized Anxiety Disorder (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.

Time frame: Baseline, week 4, 8, 12 and 16

Sleep Quality

Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI).Improvement in the Sleep Quality Score measured by the Insomnia Severity Index (ISI). Seven question added to get total score (0-28). Score of 0-7 has no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia - moderate severity and 22-28 clinical insomnia - severe.

Time frame: Baseline, week 4, 8, 12 and 16

Pain Medication

Decrease in prescription pain medication use. Measured by recording initial and changes in prescription medication names, dose and frequency

Time frame: Baseline, week 4, 8, 12 and 16

Other non-pain prescription medications

Decrease in other no-pain prescription medications. Measured by recording initial and changes in non-prescription medications names, dose and frequency

Time frame: Baseline, week 4, 8, 12 and 16

Average Pain Score

Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale

Time frame: Baseline, week 4, 8 and 12