Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000094279
Ethics application status
Approved
Date submitted
23/12/2008
Date registered
10/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aquatic physiotherapy for patients after shoulder surgery
Scientific title
Patients after shoulder surgery: a comparison of usual physiotherapy only, to usual physiotherapy plus six weeks of aquatic physiotherapy on upper limb symptoms, function, range of movement and quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder surgery patients 4288 0
Condition category
Condition code
Musculoskeletal 4365 4365 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aquatic physiotherapy sessions of specific upper limb exercise therapy, prescribed and supervised by a physiotherapist, undertaken in a warm water pool using the hydrostatic properties of the pool. Sessions of 30 minutes duration twice weekly for the first six weeks post surgery. Aquatic physiotherapy sessions provided in addition to usual care.
Usual care physiotherapy determined by treating physiotherapist including active, assisted and resisted exercises and manual therapy techniques aimed at regaining range, strength and function of the upper limb. Sessions of 20 minutes duration provided up to twice weekly post-operatively, for up to 12 weeks, depending on nature of the surgery.
Intervention code [1] 4029 0
Rehabilitation
Comparator / control treatment
Usual care physiotherapy determined by treating physiotherapist including active, assisted and resisted exercises and manual therapy techniques aimed at regaining range, strength and function of the upper limb. Sessions of 20 minutes duration provided up to twice weekly post-operatively, for up to 12 weeks, depending on nature of the surgery.
Control group
Active

Outcomes
Primary outcome [1] 5239 0
Upper limb disability (Disability of Arm, Shoulder, Hand) questionnaire
Timepoint [1] 5239 0
Baseline, six weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [1] 8747 0
Symptoms and function of the shoulder questionnaire
Timepoint [1] 8747 0
Baseline, six weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [2] 8748 0
Active range of shoulder movement (flexion, abduction, external rotation)measured using inclimometer by blinded assessor physiotherapist
Timepoint [2] 8748 0
Baseline, six weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [3] 8749 0
Hospital anxiety and depression scale
Timepoint [3] 8749 0
Baseline, 12 weeks, 52 weeks
Secondary outcome [4] 8750 0
World Health Orgainzation Quality of Life questionnaire (WHO-QOL)
Timepoint [4] 8750 0
Baseline, 12 weeks, 52 weeks

Eligibility
Key inclusion criteria
Adult
Independently living in community
Able to read and speak in English
Resident in Southern Metropolitan area of Adelaide
Shoulder surgery at Flinders Medical Centre or Noarlunga Health Services with one of the following procedure codes (based on International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10 AM) procedures tabular,Medical Benefits Schedule-Extended (MBS), 2000:
1400 48903 (decompression of subacromial space)
1404 48957 ( arthroscopic stabilisation of shoulder)
1404 48930 (stabilisationof shoulder for recurrent dislocation)
140448933 (stabilisation of shoulder for multi-directional instability)
1404 48906 (repair of rotator cuff)
1404 48909 (repair of rotator cuff with decompression of sub-acromial space)
1404 48951 (arthroscopic acromioplasty of shoulder)
1404 48915 (hemi-arthroplasty of shoulder)
1404 48918 (total arthroplasty of shoulder)
1405 48960 (arthroscopic reconstruction of shoulder)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Hydrotherapy exclusions ie:
1. Pre-existing or acquired incontinence
2. Infections of urinary tract
3. Wound infection where adequate protection is not possible
4. Infection of eyes or ears
5. Uncontrolled hypertension or uncontrolled hypotension
6. Renal dialysis patients
7. Cardiac failure especially left ventricular failure
8. Hepatitis B or C or Aquired Immune Deficiency Syndrome (AIDS) patients who are menstruating
9. Gastrointestinal infections ie diarrhoea
10. Cryptosporidium infections
11. Patients requiring full assistance in pool or who are unable to be independent to enter pool
(b) Psychiatric conditions being unable to participate
(c) Unwilling or unable to give informed consent
(d)Previous open shoulder surgery on the operated arm
(e) Unresolved worker's compensation claim for the operated shoulder

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)
Allocation involved contacting the holder of the allocation schedule, a computer generated random number schedule, held at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number chart
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
Completed
Date of first participant enrolment
Anticipated
1/12/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1349 0
5081
Recruitment postcode(s) [2] 1355 0
5042

Funding & Sponsors
Funding source category [1] 4476 0
Charities/Societies/Foundations
Name [1] 4476 0
Flinders Medical Centre (FMC) Foundation
Country [1] 4476 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre (FMC) Physiotherapy Department
Address
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 3875 0
None
Name [1] 3875 0
Address [1] 3875 0
Country [1] 3875 0
Other collaborator category [1] 504 0
Individual
Name [1] 504 0
Associate Professor Adrian Esterman
Address [1] 504 0
North Tce
University of South Australia

Adelaide 5000
Country [1] 504 0
Australia
Other collaborator category [2] 518 0
Individual
Name [2] 518 0
Professor Jegan Krishnan
Address [2] 518 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country [2] 518 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6351 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 6351 0
Ethics committee country [1] 6351 0
Australia
Date submitted for ethics approval [1] 6351 0
Approval date [1] 6351 0
25/11/2002
Ethics approval number [1] 6351 0
45/023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35027 0
Address 35027 0
Country 35027 0
Phone 35027 0
Fax 35027 0
Email 35027 0
Contact person for public queries
Name 12374 0
Joanne Nolan
Address 12374 0
Flinders Medical Centre
Physiotherapy Department
Flinders Drive
Bedford Park
South Australia 5042
Country 12374 0
Australia
Phone 12374 0
+61882045498
Fax 12374 0
+61882043040
Email 12374 0
[email protected]
Contact person for scientific queries
Name 3302 0
Joanne Nolan
Address 3302 0
Flinders Medical Centre
Physiotherapy Department
Flinders Drive
Bedford Park
South Australia 5042
Country 3302 0
Australia
Phone 3302 0
+61882045498
Fax 3302 0
+61882043040
Email 3302 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.