The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
1 other identifier
interventional
61
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedJanuary 28, 2016
January 1, 2016
1.4 years
December 7, 2015
January 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Wrist Range of Motion (ROM)
Measurement of wrist flexion/extension, radial/ulnar deviation/ and pro/supination
Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits
Secondary Outcomes (1)
Change in Hand Volume
Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits
Study Arms (2)
Whirlpool
EXPERIMENTALImmersion in Whirlpool during therapy
Hot Pack
ACTIVE COMPARATORHot Pack Application during therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Healed DRF,
- allowed to perform motion.
You may not qualify if:
- Complex regional pain syndrome,
- inability to read/understand english,
- inability to attend follow up sessions due to driving distance from clinic,
- Raynaud's phenomenon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roth McFarlane Hand & Upper Limb Centre
London, Ontario, N6A 4L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mike Szekeres, PhD (c)
Western University, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
December 7, 2015
First Posted
January 28, 2016
Study Start
December 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
January 28, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share