Distal Radius Fractures
Conditions
Keywords
distal radius fracture, rehabilitation, volar plate fixation, DASH questionnaire
Brief summary
The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.
Detailed description
Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.
Interventions
OTHERIndependent Excercises
Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.
OTHEROccupational Therapy
Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.
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
* Age 18 or greater. * Isolated distal radial fracture. * Fracture treated with volar plates, stable fixation. * Initial treatment within 4 weeks of trauma.
Exclusion criteria
* Complex fractures that require additional or different material than volar plates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion in Degrees of the Wrists | 6 months | Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-point Ordinal Pain Scale | 6 months | A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever. |
| Pinch Strength | 6 months | Pinch strength measured with the B&L pinch gauge. B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym). |
| Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 6 months | The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function. Mean and standard deviations are identical for both arms. |
| Mayo Wrist Score | 6 months | A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent. |
| Grip Strength | 6 months | Measured with use of a grip meter as the average of three attempts. |
| Gartland and Werley Score | 6 months | An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Independent Exercise Cohort Subjects who learn their therapy exercises from the surgeon and practice them independently at home. | 48 |
| Occupational Therapy Cohort Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises. | 46 |
| Total | 94 |
Baseline characteristics
| Characteristic | Occupational Therapy Cohort | Independent Exercise Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 4 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 44 Participants | 81 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 15 | 50 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 46 participants | 48 participants | 94 participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 61 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 2 / 46 |
| serious Total, serious adverse events | 0 / 48 | 0 / 46 |
Outcome results
Primary
Range of Motion in Degrees of the Wrists
Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Range of Motion in Degrees of the Wrists | 129 Degrees | Standard Deviation 22.6 |
| Occupational Therapy Cohort | Range of Motion in Degrees of the Wrists | 118 Degrees | Standard Deviation 17.7 |
Secondary
10-point Ordinal Pain Scale
A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | 10-point Ordinal Pain Scale | 0.8 units on a scale | Standard Deviation 1.4 |
| Occupational Therapy Cohort | 10-point Ordinal Pain Scale | 1.0 units on a scale | Standard Deviation 1.8 |
Secondary
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function. Mean and standard deviations are identical for both arms.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 7.8 units on a scale | Standard Deviation 7.8 |
| Occupational Therapy Cohort | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 6.7 units on a scale | Standard Deviation 6.7 |
Secondary
Gartland and Werley Score
An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Gartland and Werley Score | 0.9 units on a scale | Standard Deviation 1.2 |
| Occupational Therapy Cohort | Gartland and Werley Score | 1.1 units on a scale | Standard Deviation 1.3 |
Secondary
Grip Strength
Measured with use of a grip meter as the average of three attempts.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Grip Strength | 57 Pounds (lbs) | Standard Deviation 18.5 |
| Occupational Therapy Cohort | Grip Strength | 51 Pounds (lbs) | Standard Deviation 17.9 |
Secondary
Mayo Wrist Score
A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Mayo Wrist Score | 83.4 units on a scale | Standard Deviation 12.7 |
| Occupational Therapy Cohort | Mayo Wrist Score | 79.0 units on a scale | Standard Deviation 9.9 |
Secondary
Pinch Strength
Pinch strength measured with the B&L pinch gauge. B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Independent Exercise Cohort | Pinch Strength | 15 Pounds (lbs) | Standard Deviation 4.3 |
| Occupational Therapy Cohort | Pinch Strength | 17 Pounds (lbs) | Standard Deviation 8.6 |