손목 손상 강화 운동(WISE) 대 통증 및 기능 개선을 위한 일반적 치료 조언 (WISE-DK)

Verbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook).

Verbal advice, a leaflet, and instruction in a strength training program delivered by an occupational or physical therapist at the hospital or virtually. This is followed by two additional sessions with a therapist in the municipality, focusing on progression in the exercise program. Participants will receive written instructions (a Supervised Exercise workbook) along with a personal login to access a patient information video.

The exercise program is a highly structured system of hand and upper limb exercises. The program will enable participants to progress their exercises after the initial set-up session with the therapist. The program will utilize a range of resistance exercises based upon functional movements designed to promote recovery of the strength required for activities of daily living (e.g., chopping, lifting, pushing, jar opening).

Verbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook).

The primary outcome is the Patient Rated Wrist Evaluation (PRWE) at 6 months post-randomization: A 15 item patient-reported questionnaire that assesses pain and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area (total score ranges from 0 to 100, higher scores indicate worse wrist pain and function). The pain subscale has 5 items (0 = no pain, 10 = worst pain) and the function subscale has 10 items (0 = no difficulty, 10 = unable to do). A total score on a scale of 100 is computed from the two subscales equally weighted (0 = no disability). The total score is the trial primary outcome, with the two subscales also reported as secondary outcomes.

The PRWE pain subscale contains 5 items each of which is further rated from 0-10 (0 = no pain, 10 = worst pain). The maximum score in this section is 50 and minimum 0.

The PRWE function subscale contains 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items) and is rated from 0-10 (0 = no difficulty, 10 = unable to do). The score of all 10 items is summed and then divided by 2, resulting in a maximum score of 50 and minimum 0.

Self-reported capability focusing on activities that require use of the upper extremity including shoulder, arm, and hand activities. The PROMIS Physical Function Upper Extremity-Short Form 7a contains 7 questions scored 1-5, with 1 being unable to do the activity and 5 being able to do the activity without any difficulty.

The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). A higher score indicates greater disability.

Quality of life measured using the EuroQol 5 Dimensions (EQ-5D-5L) a validated, generalized and standardized instrument comprising a Visual Analogue Scale (VAS) measuring self-rated health and a health status instrument, consisting of a five-level response (no problems, some problems, moderate problems, severe problems and unable) for five domains related to daily activities; (i) mobility, (ii) selfcare, (iii) usual activities, (iv) pain and discomfort and (v) anxiety and depression. Responses to the health status classification system are converted into an overall score using a published utility algorithm for the Danish population. The EQ-5D health status scale ranges from negative scores -0.594 [reflective of a patient's quality of life being worse than death], 0 [death], to 1 [perfect health]. A respondent's EQ-VAS gives self-rated health on a scale where the endpoints are labelled 'best imaginable health state' (100) and 'worst imaginable health state' (0).

A 9-item participant-reported questionnaire (total scores range from 0 to 90, higher scores indicate higher self-efficacy for exercise) will be used to assess the participants' confidence in their ability to exercise

Participants will be asked to indicate how many times in the preceding week they have done specific exercises for their injured hand and upper extremity, to assess engagement with the advised exercises after wrist fracture.

All unexpected serious adverse events related to the randomized interventions will be recorded. These events will be reported by recruitment centers as they become aware of events. Serious adverse events are an adverse event that: results in death; is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapac-ity; is a congenital anomaly or birth defect; or is otherwise considered medically significant by the in-vestigator (i.e., medical events that may jeopardise the participant or may require an intervention to pre-vent one of the above characteristics/consequences).

Foreseeable adverse events will be recorded as complications both by recruitment centers and participants. AEs that are unrelated to the intervention will not be reported. AEs deemed related to the intervention that do not meet the SAE definition and are not classed as foreseeable as per the following (such as discomfort during performance of exercises), will also not be reported. Foreseeable adverse events include: increase in pain lasting more than one week; treatment-related exacerbations of other medical conditions that do not meet the definition of serious (for example angina after exertion); development of Complex Regional Pain Syndrome; surgery to the injured wrist (unless an adverse event directly related to the exercise intervention, in which case this would be an SAE); development of carpal tunnel syndrome requiring medical intervention (corticosteroid injection or surgery); wound complication in the injured wrist.

Health resource use as measured by self-reported bespoke questionnaire (including primary and secondary care consultation, additional therapy, investigations, surgery, prescribed and over-the-counter pain medication), sick leave (days), out-of-pocket expenses. Resource use will be converted into costs using standard unit cost estimates. The components will be aggregated to estimate the total cost per participant.