Plain English Summary
Background and study aims:
The use of cryotherapy (cooling therapy) in the form of ice packs, gel packs, and ice immersion are frequently used to treat minor muscle injuries. Although ice is known to be effective in decreasing pain and feeling, its effect on balance has received comparatively little attention. In addition to the various benefits of cryotherapy, reduced performance scores have been reported immediately after treatment. The role of quadriceps (thigh) and hamstring (calf) muscles for maintaining standing balance is well established, but the effect of cooling of these muscles on standing balance has not been reported previously. The aim of this study therefore is to compare the effect cooling the quadriceps and hamstring muscles on standing balance in healthy men.
Who can participate?
Healthy men aged between 20 and 30.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are asked to lie down on their back and have a cool pack placed on their thigh for 20 minutes. Those in the second group are asked to lie down on their front and have a cool pack placed on their calf for 20 minutes. Those in the third group rest for 20 minutes and do not receive any cooling. At the start of the study and after the cooling period (20 minutes), participants in all groups stand on a special plate which measures their balance.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
Rehabilitation Research Chair, King Saud University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2014 to March 2016
Who is funding the study?
Rehabilitation Research Chair, King Saud University (Saudi Arabia)
Who is the main contact?
Mr Shahnawaz Anwer
Trial website
Contact information
Type
Scientific
Primary contact
Mr Shahnawaz Anwer
ORCID ID
http://orcid.org/0000-0003-3187-8062
Contact details
King Saud University
Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
Riyadh
11433
Saudi Arabia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of quadriceps and hamstrings muscle cooling on standing balance in healthy young males
Acronym
Study hypothesis
1. The effects of quadriceps or hamstring muscles cooling on standing balance are significant in healthy individuals
2. The differences in the effects of quadriceps and hamstring muscles cooling on standing balance are significant in healthy individuals
Ethics approval
CAMS Research ethics committee, King Saud University, Saudi Arabia, 08/01/2015, ref: CAMS 21/3536
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Balance following muscle cooling
Intervention
Participants are randomised to one of three groups by lottery method.
Quadriceps cooling (QC) group: Participants are asked to lie down in a supine position and a cold pack (gel pack, temperature -60 C to -120 C) is placed on the anterior thigh (from apex of patella to mid-thigh) of the both limbs for 20 minutes.
Hamstrings cooling (HC) group: Participants are asked to lie down in a prone position and a cold pack (gel pack, temperature -60 C to -120 C) is placed on the posterior thigh (from base of the popliteal fossa to mid-thigh) of the both limbs for 20 minutes.
Control (no cooling) group: Participants rest without any intervention.
At baseline and post-cooling/rest (20 minutes) participants have their sway velocity assessed using a force plate.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Sway velocity (degree/sec) for the Unilateral Stance (US) is tested on a force plate (NeuroCom Balance Master®) at baseline and immediately after the cooling protocol.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
12/12/2014
Overall trial end date
01/03/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male
2. Age 20-30 years
3. Healthy
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
30
Participant exclusion criteria
1. History of recent previous knee injury
2. Sensory deficits in lower extremity
3. History of previous recent lower extremity surgery
Recruitment start date
10/02/2015
Recruitment end date
20/12/2015
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Rehabilitation Research Chair
College of Applied Medical Sciences, King Saud University
Building Number 24 G095/1
Riyadh
11433
Saudi Arabia
Sponsor information
Organisation
King Saud University
Sponsor details
Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
Riyadh
11433
Saudi Arabia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Rehabilitation Research Chair, King Saud University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Shahnawaz Anwer (sanwer@ksu.edu.sa)
Intention to publish date
01/07/2017
Participant level data
Available on request
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28860419