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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.
Scientific title
The effectiveness of Bodyflow therapy post Total Knee Replacement surgery: post-operation hospitalization duration and patient recovery.
Secondary ID [1] 273145 0
Nil.
Universal Trial Number (UTN)
U1111-1124-9736
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 278897 0
Condition category
Condition code
Surgery 279072 279072 0 0
Other surgery
Musculoskeletal 279105 279105 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269484 0
Treatment: Devices
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.
Control group
Placebo

Outcomes
Primary outcome [1] 279721 0
Reduction of post-surgery hospital stay duration
Timepoint [1] 279721 0
Hospital discharge + 14-days post-op.
Secondary outcome [1] 294302 0
Reduction of oedema. Assessed by circumferential measurements at 4 specified positions of the treated leg.
Timepoint [1] 294302 0
Hospital discharge + 14-days post-op.
Secondary outcome [2] 294357 0
Reduction of pain, as assessed by the patient's score on a 10-point visual scale (VAS).
Timepoint [2] 294357 0
Hospital discharge + 14-days post-op.

Eligibility
Key inclusion criteria
Candidates for Total Knee Replacement surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
sealed envelopes, opened after end of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
7/10/2011
Actual
31/10/2011
Date of last participant enrolment
Anticipated
Actual
5/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269959 0
Self funded/Unfunded
Name [1] 269959 0
Country [1] 269959 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bodyflow International PTY LTD
Address
2 Islington Street
Collingwood
Victoria 3066
Country
Australia
Secondary sponsor category [1] 268956 0
None
Name [1] 268956 0
Address [1] 268956 0
Country [1] 268956 0
Other collaborator category [1] 252273 0
Hospital
Name [1] 252273 0
Sportsmed SA
Address [1] 252273 0
32 Payneham Rd
Stepney SA 5069
Country [1] 252273 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271928 0
BellBerry
Ethics committee address [1] 271928 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 271928 0
Australia
Date submitted for ethics approval [1] 271928 0
Approval date [1] 271928 0
03/05/2011
Ethics approval number [1] 271928 0
2011-01-004

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.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 33226 0
Dr Tony Spriggins
Address 33226 0
Sportsmed SA, orthopaedic dept.
32 Payneham rd
Stepney SA 5069
Country 33226 0
Australia
Phone 33226 0
+61 8 8130 1222
Fax 33226 0
Email 33226 0
[email protected]
Contact person for public queries
Name 16473 0
Genn Dods, Physiotherapist
Address 16473 0
SPORTSMED SA
ORTHOPAEDIC DEPT
32 PAYNEHAM RD
STEPNEY SA 5069
Country 16473 0
Australia
Phone 16473 0
+61 8 8130 1222
Fax 16473 0
+61 8 8130 6635
Email 16473 0
[email protected]
Contact person for scientific queries
Name 7401 0
Genn Dods, Physiotherapist
Address 7401 0
SPORTSMED SA
ORTHOPAEDIC DEPT
32 PAYNEHAM RD
STEPNEY SA 5069
Country 7401 0
Australia
Phone 7401 0
+61 8 8130 1222
Fax 7401 0
+61 8 8130 6635
Email 7401 0
[email protected]

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.