Condition category
Musculoskeletal Diseases
Date applied
25/12/2016
Date assigned
06/01/2017
Last edited
06/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 MasterĀ®) 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

http://ksu.edu.sa/en/

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

Publication citations

Additional files

Editorial Notes