Distal Radius FracturesNCT00438750
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
A study testing Independent Excercises and Occupational Therapy in people with Distal Radius Fractures, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Independent Excercises and Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater.
- Isolated distal radial fracture.
- Fracture treated with volar plates, stable fixation.
- Initial treatment within 4 weeks of trauma.
Who cannot join
- Complex fractures that require additional or different material than volar plates.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Independent Excercises, Occupational Therapy
- Keywords
- distal radius fracture, rehabilitation, volar plate fixation, DASH questionnaire
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Independent ExcercisesOther
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.
Occupational TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Independent Home Exercises | Experimental | Subjects who learn their therapy exercises from the surgeon and practice them independently at home. Receives: Other: Independent Excercises |
| Formal Therapy | Experimental | Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises. Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
10-point Ordinal Pain Scale
A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Grip Strength
Measured with use of a grip meter as the average of three attempts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438750
- Sponsor's protocol ID
- 2006-P-001157
- Status last verified
- Jun 2012
- First submitted
- 20 Feb 2007
- Last updated
- 8 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
- ClinicalTrials.gov ID
- NCT00438750
- Acronym / sponsor ID
- 2006-P-001157
- Conditions
- Distal Radius Fractures
- Keywords
- distal radius fracture, rehabilitation, volar plate fixation, DASH questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Independent Home Exercises | Experimental | Other: Independent ExcercisesSubjects who learn their therapy exercises from the surgeon and practice them independently at home. |
| Formal Therapy | Experimental | Other: Occupational TherapySubjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or greater.
- Isolated distal radial fracture.
- Fracture treated with volar plates, stable fixation.
- Initial treatment within 4 weeks of trauma.
Key exclusion criteria (1 listed)
- Complex fractures that require additional or different material than volar plates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Independent ExcercisesSubjects 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. | Other | Independent Home Exercises |
| Occupational TherapySubjects 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. | Other | Formal Therapy |
Primary outcome
Range of Motion in Degrees of the Wrists
Time frame: 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.
6 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: 6 months
10-point Ordinal Pain Scale
Time frame: 6 months
Pinch Strength
Time frame: 6 months
Gartland and Werley Score
Time frame: 6 months
Mayo Wrist Score
Time frame: 6 months
Grip Strength
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Independent Excercises and Occupational Therapy in people with Distal Radius Fractures, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion in Degrees of the Wrists (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.