Clinical Outcomes of USCTR vs. mOCTR

Primary outcomes

1. Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.

   Time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

   QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).

   For the primary analysis, change in QuickDASH score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in QuickDASH will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.

2. Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-SSS.

   Time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

   The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-SSS) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.

   For the primary analysis, change in BCTQ-SSS score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in BCTQ-SSS will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.

3. Measure the effect of USCTR vs mOCTR on the longitudinal change in hand grip strength.

   Time frame: Change from baseline to 3 months, and 12 months post CTR procedure

   Manually tested using a handheld dynamometer.

   Between the mOCTR and USCTR groups, will compare hand grip strength across each time point (i.e. baseline - 3 months; baseline - 12 months).

4. Measure the effect of USCTR vs mOCTR on the longitudinal change in pinch (tip, palmar, and key) strength.

   Time frame: Change from baseline to 3 months, and 12 months post CTR procedure

   Manually tested using a pinch gauge.

   Between the mOCTR and USCTR groups, will compare pinch (tip, palmar, and key) strength across each time point (i.e. baseline - 3 months; baseline - 12 months).

5. Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition

   Time frame: Change from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

   Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)

   The Global Rate of Change Scale (GROC) will be captured at nine occasions of assessment: baseline and 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.

6. Change in military work status as assessed using single-item self-report assessment

   Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

   Participants will complete a questionnaire to depict when normal work or daily activities commenced.

   The primary focus will be on outcomes up to 1 year.

7. Surgical time during procedure (minutes)

   Time frame: At time of procedure, measured as day 0

   On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes

8. Change in self-reported satisfaction as assessed using a satisfaction rating scale

   Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

   Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.

   Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.

   Will compare participant satisfaction across arms in terms of symptom improvement, incision appearance, and recovery, with the primary focus being on outcomes up to 1 year.

9. Change in self-reported pain as assessed using the 11-item Numeric Pain Rating Scale (NPRS) participant pain levels over 1 month following the CTR procedure.

   Time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure

   The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).

10. Change in pain medication usage as assessed using single-item self-report assessment

    Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

    Participant self-reported pain medication usage. Participant will respond with responses ranging from "less than once a week', "once a week", "several times a week", "daily", "multiple times per day", "or did not use". "Did not use" will represent the minimum value, and "multiple times per day" will represent the maximum value.

    Participant self-reported pain medication usage (e.g., cumulative dosage, drug category, duration of use, etc.) will be captured at nine occasions of assessment: 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.

11. Incision length in cm

    Time frame: At time of procedure, measured as day 0

    On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm

12. Change in self-reported pain as assessed using the 11-item Numeric Pain Rating Scale (NPRS)

    Time frame: At time of procedure, measured as day 0

    Using the 11-item Numeric Pain Rating Scale (NPRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.

    The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).

13. Change in self-reported pain as assessed using the modified 2-item CTS Palmar Pain Scale (4 items) over 1 month following CTR procedure

    Time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure

    The modified 2-item CTS Palmar Pain Scale (4 items on palmar and incision pain) inquires about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms