Distal Radius FractureNCT02667405
The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
A study testing Hot Pack and Whirlpool in people with Distal Radius Fracture, run by Western University, Canada at 1 site in Canada.
Trial summary
This study investigates the effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Hot Pack and Whirlpool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healed DRF,
- allowed to perform motion.
Who cannot join
- Complex regional pain syndrome,
- inability to read/understand english,
- inability to attend follow up sessions due to driving distance from clinic,
- Raynaud's phenomenon
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of motion and volume of the hand are evaluated, with measurements taking place before and immediately after heat during each visit.
Read the detailed description
This study investigates the short term effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF) during a therapy visit. Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits.
Measurements of wrist and forearm range of motion, and volume of the hand are recorded before and immediately after heat for each visit, effectively creating six measurement time points. Change scores are recorded for range of motion and for volume, and analyzed using MANOVA to determine differences between groups.
- Conditions
- Distal Radius Fracture
- Being tested
- Hot Pack, Whirlpool
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot PackProcedure or surgery
Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes
WhirlpoolProcedure or surgery
Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Whirlpool | Experimental | Immersion in Whirlpool during therapy Receives: Procedure: Whirlpool |
| Hot Pack | Active comparator | Hot Pack Application during therapy. Receives: Procedure: Hot Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrist Range of Motion (ROM)
Measurement of wrist flexion/extension, radial/ulnar deviation/ and pro/supination
Measured: Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits
Secondary outcomes (1)
Change in Hand Volume
Volumetric measurement of the hand using a standardized volunteer
Measured: Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike Szekeres, Western University, Canada
- Investigators
- Mike Szekeres, PhD (c), Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667405
- Sponsor's protocol ID
- 6712
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
- ClinicalTrials.gov ID
- NCT02667405
- Acronym / sponsor ID
- 6712
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jan 2016 (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.
This study investigates the effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of motion and volume of the hand are evaluated, with measurements taking place before and immediately after heat during each visit.
Detailed description
This study investigates the short term effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF) during a therapy visit. Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits.
Measurements of wrist and forearm range of motion, and volume of the hand are recorded before and immediately after heat for each visit, effectively creating six measurement time points. Change scores are recorded for range of motion and for volume, and analyzed using MANOVA to determine differences between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whirlpool | Experimental | Procedure: WhirlpoolImmersion in Whirlpool during therapy |
| Hot Pack | Active comparator | Procedure: Hot PackHot Pack Application during therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healed DRF,
- allowed to perform motion.
Key exclusion criteria (4 listed)
- Complex regional pain syndrome,
- inability to read/understand english,
- inability to attend follow up sessions due to driving distance from clinic,
- Raynaud's phenomenon
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 |
|---|---|---|
| Hot PackPatients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes | Procedure or surgery | Hot Pack |
| WhirlpoolPatients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes | Procedure or surgery | Whirlpool |
Primary outcome
Change in Wrist Range of Motion (ROM)
Time frame: Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits
Measurement of wrist flexion/extension, radial/ulnar deviation/ and pro/supination
1 secondary outcome
Change in Hand Volume
Time frame: Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits
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 28 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Mike Szekeres, PhD (c) principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Pack and Whirlpool in people with Distal Radius Fracture, run by Western University, Canada at 1 site in Canada.
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 2 inclusion and 4 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 28 Jan 2016. 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 Canada. 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?
Change in Wrist Range of Motion (ROM) (time frame: Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits). 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 28 Jan 2016.