NCT02667405

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

December 7, 2015

Last Update Submit

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

EXPERIMENTAL

Immersion in Whirlpool during therapy

Procedure: Whirlpool

Hot Pack

ACTIVE COMPARATOR

Hot Pack Application during therapy.

Procedure: Hot Pack

Interventions

Hot PackPROCEDURE

Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes

Hot Pack
WhirlpoolPROCEDURE

Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes

Whirlpool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Mike Szekeres, PhD (c)

    Western University, Canada

    PRINCIPAL INVESTIGATOR

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

Locations