Acute Injury of Upper Extremity
Conditions
Brief summary
Primary null hypothesis: • Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS \[Patient Reported Outcome Measurement Information System\] upper extremity) 8 weeks after injury. Secondary null hypotheses: * Keeping a personal diary has no effect on avoidance of painful activities (assessed w/ PROMIS pain interference) 8 weeks after injury. * Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS depression) 8 weeks after injury. * There are no factors associated with upper-extremity disability 8 weeks after injury.
Detailed description
Recovery from injury can be counterintuitive and taxing. It is natural to feel protective and prepare for the worst. Healthy exercises can seem unwise. It can seem like things are taking too long or getting off track. We have noticed that small improvements such as being able to resume a cherished activity (e.g. knitting or swimming) or achieving some success with exercises (e.g. obtaining full supination after fracture of the distal radius), can help patients feel like things are going to be okay. That feeling seems to make it easier to do exercises and resume function activities. We wonder if awareness of this process (mindfulness) would help patients recover more rapidly. Keeping a journal is one method for encouraging mindfulness. It allows patients to express themselves and tell their stories. There is evidence that such narrative medicine can be healing. We anticipate that patients who perceive little or no progress will be able to look back on how they were feeling earlier on and appreciate that things are moving in the right direction. We also hope that their journal material might be useful for other patients that are having trouble seeing the light at the end of the tunnel, so as part of this study, we will get permission to use their quotes anonymously in future patient care materials and future research. To our knowledge, research on the impact of keeping a personal diary/journal of recovery is scant, particularly pertaining to recovery from upper extremity trauma. Explanatory variables: * Diary or no Diary * Diagnosis (fracture, sprain, contusion, skin laceration, complex laceration \[tendon, nerve\]) * Location (hand, wrist, forearm, elbow, arm, shoulder) * Sex * Age * Education * Work status * Insurance (worker's compensation, private, public, other) * Visit type * Prior treatment received * Other pain conditions * Smoking status * Marital status * Physical or Occupational Therapy
Interventions
OTHERDiary
Subject keeps diary of recovery
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All new patients (\>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) * English fluency and literacy * Able to take informed consent
Exclusion criteria
* Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Disability Measured by PROMIS Upper Extremity | 8 weeks | Upper Extremity Disability measured by PROMIS Upper Extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Avoidance of Painful Activities Measured by PROMIS Pain Interference | 8 weeks | Avoidance of painful activities measured by PROMIS Pain Interference |
| Symptoms of Depression Measured by PROMIS Depression | 8 weeks | Symptoms of depression measured by PROMIS Depression |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diary Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
Diary: Subject keeps diary of recovery | 6 |
| No Diary Control Group | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | No Diary | Total | Diary |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 7 Participants | 5 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 16 | 51 years STANDARD_DEVIATION 19 |
| Region of Enrollment United States | 3 participants | 9 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
Upper Extremity Disability Measured by PROMIS Upper Extremity
Upper Extremity Disability measured by PROMIS Upper Extremity
Time frame: 8 weeks
Population: All of the subjects were lost to follow up in both groups.
Secondary
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Avoidance of painful activities measured by PROMIS Pain Interference
Time frame: 8 weeks
Population: All of the subjects were lost to follow up.
Secondary
Symptoms of Depression Measured by PROMIS Depression
Symptoms of depression measured by PROMIS Depression
Time frame: 8 weeks
Population: All of the subjects were lost to follow up.