Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS) |
The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable). |
baseline, 2 weeks |
|
| Secondary |
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms. |
baseline, 2 weeks |
|
| Secondary |
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form |
The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. |
baseline |
|
| Secondary |
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form |
The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. |
2 weeks |
|
| Secondary |
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form |
The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. |
baseline |
|
| Secondary |
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form |
The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. |
2 weeks |
|
| Secondary |
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form |
The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. |
baseline |
|
| Secondary |
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form |
The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. |
2 weeks |
|
| Secondary |
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS) |
The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome. |
baseline |
|
| Secondary |
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS) |
The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome. |
2 weeks |
|
| Secondary |
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI) |
The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness. |
baseline |
|
| Secondary |
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI) |
The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness. |
2 weeks |
|
| Secondary |
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation |
Conditioned Pain Modulation (CPM) was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).] |
baseline, 2 weeks |
|
| Secondary |
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) |
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation. |
baseline |
|
| Secondary |
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy |
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation. |
2 weeks |
|
| Secondary |
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity |
Participants immersed their hand in a cold water bath, and at thirty seconds after hand immersion, they rated the cold pain intensity on a scale of 0-100. A higher score indicating higher pain intensity. |
baseline, 2 weeks |
|
| Secondary |
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee |
To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT). |
baseline, 2 weeks |
|
| Secondary |
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee |
To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT). |
baseline, 2 weeks |
|
