Distal Radius FracturesNCT01518179
Compression Gloves for Distal Radius Fracture
A study testing Made-to-Measure Compression Gloves and Routine follow up and treatment in people with Distal Radius Fractures and Fracture of Lower End of Radius, run by Clalit Health Services at 2 sites in Israel.
Trial summary
Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength. Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Distal Radius Fractures, Fracture of Lower End of Radius, Colles' Fracture
- What is being tested?
- Made-to-Measure Compression Gloves and Routine follow up and treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2012to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.
- Patients who demonstrate at enrolment at least two of the following:
- Pain,
- limited range of motion of the fingers and the wrist,
- limited strength (weakness of the hand/fingers),
- swelling /edema,
- Limited hand functions during performance of Activities of Daily Living (ADL).
Who cannot join
- Neuropathy
- Peripheral vascular disease
- End stage renal disease
- Previous impairment of fingers/wrist range of motion.
- Previous Lymphedema of the injured hand
- Receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids).
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Clalit Health Services, Haifa and Western Galilee District
Haifa
Clalit Health Services
Haifa
About this study
Official title: The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.
Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).
Read more
This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.
Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.
ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):
S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).
S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)
Read the detailed description
Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.
- Conditions
- Distal Radius Fractures, Fracture of Lower End of Radius, Colles' Fracture, Smith's Fracture
- Being tested
- Made-to-Measure Compression Gloves, Routine follow up and treatment
- Keywords
- Colles' Fracture, Compression Bandages, Occupational therapy, Rehabilitation, Smith's fracture
- Medical subject headings
- Wrist Fractures, Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Made-to-Measure Compression GlovesDevice
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Routine follow up and treatmentOther
Control
| Study group | Role | What they receive |
|---|---|---|
| Made-to-Measure Compression Gloves | Experimental | Made-to-Measure Compression Gloves in addition to routine follow up and treatment. Receives: Device: Made-to-Measure Compression Gloves |
| Control | Other | Routine follow up and treatment Receives: Other: Routine follow up and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Measured: 1 year
Secondary outcomes (5)
Swelling of the hand and fingers (using CM ribbon)
Swelling of the hand and fingers (using CM ribbon)
Measured: 10 week
Range of motion of the fingers and wrist (using Goniomater)
Range of motion of the fingers and wrist (using Goniomater)
Measured: 10 weeks
Strength of the hand (using the Gamar Dynamometer in KG).
Strength of the hand (using the Gamar Dynamometer in KG).
Measured: 10 weeks
Pain (using VAS as part of PRWE)
Pain (using VAS as part of PRWE)
Measured: 10 weeks
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startApr 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Benny Brnfeld, MD, Principal investigator, Clalit Health ServicesUzi Milman, MD, Study director, Clalit Health ServicesNaomi Schreuer, Ph.D., OTR, Study chair, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAELInbar Miler, OCT, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518179
- Sponsor's protocol ID
- K-11-0131-CTIL
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller-Shahabar I, Schreuer N, Katsevman H, Bernfeld B, Cons A, Raisman Y, Milman U. Efficacy of Compression Gloves in the Rehabilitation of Distal Radius Fractures: Randomized Controlled Study. Am J Phys Med Rehabil. 2018 Dec;97(12):904-910. doi: 10.1097/PHM.0000000000000998.
PubMed 29994792
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
- ClinicalTrials.gov ID
- NCT01518179
- Acronym / sponsor ID
- K-11-0131-CTIL
- Conditions
- Distal Radius Fractures, Fracture of Lower End of Radius, Colles' Fracture, Smith's Fracture
- Keywords
- Colles' Fracture, Compression Bandages, Occupational therapy, Rehabilitation, Smith's fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- Apr 2012
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.
Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).
This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.
Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.
ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):
S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).
S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)
Detailed description
Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Made-to-Measure Compression Gloves | Experimental | Device: Made-to-Measure Compression GlovesMade-to-Measure Compression Gloves in addition to routine follow up and treatment. |
| Control | Other | Other: Routine follow up and treatmentRoutine follow up and treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.
- Patients who demonstrate at enrolment at least two of the following:
Key exclusion criteria (7 listed)
- Neuropathy
- Peripheral vascular disease
- End stage renal disease
- Previous impairment of fingers/wrist range of motion.
- Previous Lymphedema of the injured hand
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 |
|---|---|---|
| Made-to-Measure Compression GlovesMade-to-Measure Compression Gloves in addition to routine follow up and treatment. | Device | Made-to-Measure Compression Gloves |
| Routine follow up and treatmentControl | Other | Control |
Primary outcome
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Time frame: 1 year
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
5 secondary outcomes
Swelling of the hand and fingers (using CM ribbon)
Time frame: 10 week
Range of motion of the fingers and wrist (using Goniomater)
Time frame: 10 weeks
Strength of the hand (using the Gamar Dynamometer in KG).
Time frame: 10 weeks
Pain (using VAS as part of PRWE)
Time frame: 10 weeks
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Results publication: PubMed 29994792Miller-Shahabar I, Schreuer N, Katsevman H, Bernfeld B, Cons A, Raisman Y, Milman U. Efficacy of Compression Gloves in the Rehabilitation of Distal Radius Fractures: Randomized Controlled Study. Am J Phys Med Rehabil. 2018 Dec;97(12):904-910. doi: 10.1097/PHM.0000000000000998.
Related trials for Distal Radius Fractures
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Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures
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X-BS Ortho Bone Graft Study
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Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
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.
Benny Brnfeld, MD principal investigator
Clalit Health Services
Uzi Milman, MD study director
Clalit Health Services
Naomi Schreuer, Ph.D., OTR study chair
Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Made-to-Measure Compression Gloves and Routine follow up and treatment in people with Distal Radius Fractures and Fracture of Lower End of Radius, run by Clalit Health Services at 2 sites in Israel.
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 7 inclusion and 7 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518179, which also lists 1 linked publication.
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 31 Jan 2019.