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

January 27, 2016 updated by: Mike Szekeres, Western University, Canada
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Roth McFarlane Hand & Upper Limb Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whirlpool
Immersion in Whirlpool during therapy
Procedure: Whirlpool
Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes
Active Comparator: Hot Pack
Hot Pack Application during therapy.
Procedure: Hot Pack
Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Volumetric measurement of the hand using a standardized volunteer
Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: Mike Szekeres, PhD (c), Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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