Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611001049965
Ethics application status
Approved
Date submitted
3/10/2011
Date registered
6/10/2011
Date last updated
23/04/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
The effectiveness of Bodyflow therapy post Total Knee Replacement surgery: post-operation hospitalization duration and patient recovery.
Query!
Scientific title
The effectiveness of Bodyflow therapy post Total Knee Replacement surgery: post-operation hospitalization duration and patient recovery.
Query!
Secondary ID [1]
273145
0
Nil.
Query!
Universal Trial Number (UTN)
U1111-1124-9736
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement
278897
0
Query!
Condition category
Condition code
Surgery
279072
279072
0
0
Query!
Other surgery
Query!
Musculoskeletal
279105
279105
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Low voltage electrical stimulation of muscles to reduce post-surgery oedema. Therapy is delivered by placing 1 pair of skin electrodes just above the knee, and another pair just below the knee that was operated on. Low voltage (<5V) pulses will slightly stimulate the muscles in thigh and calf which will help reduction of oedema. Treatment is started 2 days post operation with in-hospital treatment, until the day of hospital discharge. From that day on the patient will administer the treatment at home (using a handheld device) until 2 weeks after operation. Treatments are administered in 3-4 sessions of 20 minutes daily. This treatment is in addition to the standard care.
Query!
Intervention code [1]
269484
0
Treatment: Devices
Query!
Comparator / control treatment
Placebo group and Standard Treatment group: the placebo group will have all electrodes etc applied as for 'normal' stimulation, but the intensity of stimulus will be too low (or absent) to trigger any effect on the muscles. The patient is blinded to whether or not stimulation occurs, and will receive the standard care. The Standard group will not get any Bodyflow treatment (or simulation of it), only the standard care of compression socks.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
279721
0
Reduction of post-surgery hospital stay duration
Query!
Assessment method [1]
279721
0
Query!
Timepoint [1]
279721
0
Hospital discharge + 14-days post-op.
Query!
Secondary outcome [1]
294302
0
Reduction of oedema. Assessed by circumferential measurements at 4 specified positions of the treated leg.
Query!
Assessment method [1]
294302
0
Query!
Timepoint [1]
294302
0
Hospital discharge + 14-days post-op.
Query!
Secondary outcome [2]
294357
0
Reduction of pain, as assessed by the patient's score on a 10-point visual scale (VAS).
Query!
Assessment method [2]
294357
0
Query!
Timepoint [2]
294357
0
Hospital discharge + 14-days post-op.
Query!
Eligibility
Key inclusion criteria
Candidates for Total Knee Replacement surgery
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients with a past history of Deep Vein Thrombosis or Thromboembolic event,
Patients with an implanted pacemaker or Internal Cardioverter Defibrillator,
Pregnant women,
Patients suffering from Diabetes type 1,
Patients whom have a bleeding disorder such as Haemophilia or associated Coagulopathy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelopes, opened after end of surgery.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Date of first participant enrolment
Anticipated
7/10/2011
Query!
Actual
31/10/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
5/10/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
72
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
269959
0
Self funded/Unfunded
Query!
Name [1]
269959
0
Query!
Address [1]
269959
0
Query!
Country [1]
269959
0
Australia
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bodyflow International PTY LTD
Query!
Address
2 Islington Street
Collingwood
Victoria 3066
Query!
Country
Australia
Query!
Secondary sponsor category [1]
268956
0
None
Query!
Name [1]
268956
0
Query!
Address [1]
268956
0
Query!
Country [1]
268956
0
Query!
Other collaborator category [1]
252273
0
Hospital
Query!
Name [1]
252273
0
Sportsmed SA
Query!
Address [1]
252273
0
32 Payneham Rd
Stepney SA 5069
Query!
Country [1]
252273
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
271928
0
BellBerry
Query!
Ethics committee address [1]
271928
0
229 Greenhill Road
Dulwich
South Australia 5065
Query!
Ethics committee country [1]
271928
0
Australia
Query!
Date submitted for ethics approval [1]
271928
0
Query!
Approval date [1]
271928
0
03/05/2011
Query!
Ethics approval number [1]
271928
0
2011-01-004
Query!
Summary
Brief summary
This study evaluates the effects of adding Bodyflow therapy to the standard of care treatment after patients underwent a surgical procedure for total knee replacement (TKR). The Bodyflow treatment will consist of an in-hospital component, as well as a self-administered component after the patient has been discharged. The effect of the treatment on the duration of the post-operative hospital stay will be the primary objective, while its effects on peripheral tissue oedema and patient’s pain scores are evaluated as secondary objectives.
Query!
Trial website
nil
Query!
Trial related presentations / publications
nil
Query!
Public notes
Query!
Contacts
Principal investigator
Name
33226
0
Dr Tony Spriggins
Query!
Address
33226
0
Sportsmed SA, orthopaedic dept.
32 Payneham rd
Stepney SA 5069
Query!
Country
33226
0
Australia
Query!
Phone
33226
0
+61 8 8130 1222
Query!
Fax
33226
0
Query!
Email
33226
0
[email protected]
Query!
Contact person for public queries
Name
16473
0
Mr Genn Dods, Physiotherapist
Query!
Address
16473
0
SPORTSMED SA
ORTHOPAEDIC DEPT
32 PAYNEHAM RD
STEPNEY SA 5069
Query!
Country
16473
0
Australia
Query!
Phone
16473
0
+61 8 8130 1222
Query!
Fax
16473
0
+61 8 8130 6635
Query!
Email
16473
0
[email protected]
Query!
Contact person for scientific queries
Name
7401
0
Mr Genn Dods, Physiotherapist
Query!
Address
7401
0
SPORTSMED SA
ORTHOPAEDIC DEPT
32 PAYNEHAM RD
STEPNEY SA 5069
Query!
Country
7401
0
Australia
Query!
Phone
7401
0
+61 8 8130 1222
Query!
Fax
7401
0
+61 8 8130 6635
Query!
Email
7401
0
[email protected]
Query!
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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF