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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667405
• Other study ID #: 6712
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: January 27, 2016
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures

Intervention

Procedure:
• Hot Pack
Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes
• Whirlpool
Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes

Locations

Country	Name	City	State
Canada	Roth McFarlane Hand & Upper Limb Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Hand Volume	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	No