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The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hot Pack
Whirlpool
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healed DRF,
  • allowed to perform motion.

Exclusion Criteria:

  • Complex regional pain syndrome,
  • inability to read/understand english,
  • inability to attend follow up sessions due to driving distance from clinic,
  • Raynaud's phenomenon

Sites / Locations

  • Roth McFarlane Hand & Upper Limb Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whirlpool

Hot Pack

Arm Description

Immersion in Whirlpool during therapy

Hot Pack Application during therapy.

Outcomes

Primary Outcome Measures

Change in Wrist Range of Motion (ROM)
Measurement of wrist flexion/extension, radial/ulnar deviation/ and pro/supination

Secondary Outcome Measures

Change in Hand Volume
Volumetric measurement of the hand using a standardized volunteer

Full Information

First Posted
December 7, 2015
Last Updated
January 27, 2016
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02667405
Brief Title
The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
Official Title
The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whirlpool
Arm Type
Experimental
Arm Description
Immersion in Whirlpool during therapy
Arm Title
Hot Pack
Arm Type
Active Comparator
Arm Description
Hot Pack Application during therapy.
Intervention Type
Procedure
Intervention Name(s)
Hot Pack
Intervention Description
Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes
Intervention Type
Procedure
Intervention Name(s)
Whirlpool
Intervention Description
Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes
Primary Outcome Measure Information:
Title
Change in Wrist Range of Motion (ROM)
Description
Measurement of wrist flexion/extension, radial/ulnar deviation/ and pro/supination
Time Frame
Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits
Secondary Outcome Measure Information:
Title
Change in Hand Volume
Description
Volumetric measurement of the hand using a standardized volunteer
Time Frame
Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healed DRF, allowed to perform motion. Exclusion Criteria: Complex regional pain syndrome, inability to read/understand english, inability to attend follow up sessions due to driving distance from clinic, Raynaud's phenomenon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Szekeres, PhD (c)
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roth McFarlane Hand & Upper Limb Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist

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