Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000134325
Ethics application status
Approved
Date submitted
10/03/2008
Date registered
14/03/2008
Date last updated
14/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of icing a swollen knee joint on quadriceps muscle activation.
Scientific title
The effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee injury 2917 0
Knee surgery 2918 0
Knee arthritis 2919 0
Condition category
Condition code
Injuries and Accidents 3050 3050 0 0
Other injuries and accidents
Surgery 3051 3051 0 0
Other surgery
Musculoskeletal 3052 3052 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 subjects with no previous history of knee joint pathology had their knee joint infused with dextrose saline to a standardised intra-articular pressure of 50mmHg to mimic the swelling associated with knee injury, surgey and arthritis.

Subjects were randomly assigned to a cryotherapy (n=8) or control (n=7) group.

The cryotherapy group had crushed ice wrapped around their knee joint on a single occasion for a 20 minute duration.
Intervention code [1] 2647 0
Treatment: Other
Comparator / control treatment
The control group did not receive an intervention but remained in a seated position for the 20 minute intervention period.
Control group
Active

Outcomes
Primary outcome [1] 3935 0
Quadriceps peak torque during maximum voluntary isometric contractions performed at 60 degrees of knee joint flexion.
Timepoint [1] 3935 0
Baseline, pre knee joint infusion (10 minutes later), post knee joint infusion, post intervention
Secondary outcome [1] 6615 0
Quadriceps electromyography amplitude (root mean square)
Timepoint [1] 6615 0
Baseline, pre knee joint infusion (10 minutes later), post knee joint infusion, post intervention
Secondary outcome [2] 6616 0
Quadriceps muscle fibre conduction velocity (estimated using custom designed surface electrode)
Timepoint [2] 6616 0
Baseline, pre knee joint infusion (10 minutes later), post knee joint infusion, post intervention

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A previous history of knee joint pathology to both knee joints.

A history of spinal surgery or lower limb surgery in the past 5 years.

Back pain in the last 6 months with associated neurological signs or symptoms

Any pathology that precluded the participation in maximum strength testing

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested volunteers were instructed to contact an administrative assistant at the Health and Rehabilitation Research Centre, AUT University. Once recruited, subjects were randomly allocated to either the control or cryotherapy group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 817 0
New Zealand
State/province [1] 817 0
Auckland

Funding & Sponsors
Funding source category [1] 3169 0
University
Name [1] 3169 0
AUT University
Country [1] 3169 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
55 Wellesly Street East
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 2841 0
University
Name [1] 2841 0
University of Auckland
Address [1] 2841 0
Park Road
Grafton Auckland 1023
Country [1] 2841 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5149 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5149 0
650 Great South Road
Penrose Auckland
Ethics committee country [1] 5149 0
New Zealand
Date submitted for ethics approval [1] 5149 0
Approval date [1] 5149 0
12/09/2006
Ethics approval number [1] 5149 0
NTX06/07/075

Summary
Brief summary
Objective:
Arthrogenic muscle inhibition (AMI) contributes to quadriceps weakness and atrophy in knee arthritis and following joint injury. This laboratory based study examined the efficacy of cryotherapy in reducing quadriceps AMI caused by intra-articular swelling.

Methods:
Fifteen subjects without knee pathology participated, and were randomly assigned to a cryotherapy (n=8) or control (n=7) group. Electromyographic signals (EMG) from vastus medialis and quadriceps torque measurements were recorded during maximum effort isometric contractions. All subjects then received an experimental joint infusion, whereby dextrose saline was injected into the knee to an intra-articular pressure of 50 mmHg. EMG and torque measures were repeated. Thereafter, the cryotherapy group had ice applied to the knee for 20 minutes while the control group did not receive an intervention. EMG and torque measures were then collected again. Quadriceps peak torque, muscle fibre conduction velocity (MFCV) and the root mean square (RMS) of EMG signals from vastus medialis were analysed.

Results:
Quadriceps peak torque, MFCV and RMS declined significantly following joint infusion (p = 0.001). Cryotherapy led to a significant increase in quadriceps torque and MFCV compared to control subjects (p < 0.05). There was a trend for RMS to increase more in the cryotherapy group relative to the control group (p = 0.09).

Conclusions:
The study demonstrated that cryotherapy is effective in reducing AMI induced by swelling. Cryotherapy may allow earlier and more effective quadriceps strengthening to take place in patients with knee joint pathology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28430 0
Address 28430 0
Country 28430 0
Phone 28430 0
Fax 28430 0
Email 28430 0
Contact person for public queries
Name 11587 0
Jane Galle
Address 11587 0
Health and Rehabilitation Research Centre
AUT University
90 Akoranga Drive
Northcote Auckland 0627
Country 11587 0
New Zealand
Phone 11587 0
+64 9 9219999 ext. 7194
Fax 11587 0
Email 11587 0
jane.galle@aut.ac.nz
Contact person for scientific queries
Name 2515 0
David Rice
Address 2515 0
Health and Rehabilitation Research Centre
AUT University
90 Akoranga Drive
Northcote Auckland 0627
Country 2515 0
New Zealand
Phone 2515 0
+64 9 9219999 ext. 7032
Fax 2515 0
Email 2515 0
david.rice@aut.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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