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Trial registered on ANZCTR


Registration number
ACTRN12605000685617
Ethics application status
Approved
Date submitted
19/10/2005
Date registered
24/10/2005
Date last updated
24/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of physiotherapy after hydrodilatation for the painful stiff shoulder: a randomised placebo-controlled trial
Scientific title
Randomised placebo controlled trial of physiotherapy after hydrodilatation for adhesive capsulitis - does it improve pain and function?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesive Capsulitis 833 0
Condition category
Condition code
Physical Medicine / Rehabilitation 900 900 0 0
Pain management
Physical Medicine / Rehabilitation 901 901 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were randomly assigned to a 6-week physiotherapy or placebo treatment group, which commenced 3-5 days after hydrodilatation. All hydrodilatations were performed according a standardized protocol. Depomedrol (40 mg, 1 ml) and normal saline were injected to a total volume of up to 90ml or until filling of the subscapular bursa, capsular rupture or participant requests termination of the procedure.
Project physiotherapists were trained in the standardised protocol for both the physiotherapy and the placebo treatments. Both treatments were performed twice per week for the first two weeks and then once per week for the remaining four weeks (8 visits, 30 minutes each). The placebo treatment consisted of inoperable ultrasound and light application of an inert gel. The physiotherapy treatment was standardised and progressed according to specific criteria. Specific interventions included muscle stretching techniques both passive and self executed to stretch muscles passing over the glenohumeral joint, cervical and thoracic spine mobilisation, glenohumeral joint passive accessory glides, glenohumeral joint passive physiological mobilisation, strength and co-ordination exercises for rotator cuff and scapular stabilisers, and proprioceptive challenge.
Intervention code [1] 728 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1166 0
The Shoulder Pain and Disability Index (SPADI) is a self-administered shoulder-specific disability index consisting of 13 items divided into pain and disability subscales.
Timepoint [1] 1166 0
Measured as baseline, 6 weeks, 3 and 6 months. The primary endpoint was at 3 months.
Secondary outcome [1] 2134 0
1. Participant's overall assessment of pain was measured with a 10-cm Likert scale comprising a vertical line labeled "no pain" at the bottom (0) and "maximal imaginable pain" at the top.
Timepoint [1] 2134 0
Measured at baseline, 6 weeks, 3 and 6 months.
Secondary outcome [2] 2135 0
2. Range of active shoulder movement was measured according to a standardised protocol.
Timepoint [2] 2135 0
Measured at baseline, 6 weeks, 3 and 6 months.
Secondary outcome [3] 2136 0
3. The Assessment of Quality of Life (AQoL) instrument measures health-related quality of life and can be converted into an utility index using utility weights derived from an Australian population sample.
Timepoint [3] 2136 0
Measured at baseline, 6 weeks, 3 and 6 months.
Secondary outcome [4] 2137 0
4. Perceived recovery was measured on a 7-point ordinal scale ranging from much worse to completely recovered to estimate the percentage of patients with a successful outcome, defined as much improved or completely recovered.
Timepoint [4] 2137 0
Measured at baseline, 6 weeks, 3 and 6 months.
Secondary outcome [5] 2138 0
5. Adverse effects elicited by the use of open-ended questions.
Timepoint [5] 2138 0
Measured at baseline, 6 weeks, 3 and 6 months.
Secondary outcome [6] 2139 0
6. Costs including direct health care and non-health care costs and indirect costs were elicited by self completed questionnaire/diary completed weekly for the entire 6-month follow-up period.
Timepoint [6] 2139 0
Measured at baseline, 6 weeks, 3 and 6 months.

Eligibility
Key inclusion criteria
i) symptoms of pain and stiffness in predominantly one shoulder for > 3 months; ii) restriction of passive motion of greater than 30o in two or more planes of movement, measured to onset of pain with a gravity inclinometer; iii) adults.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) severe pain at rest, defined as > 7 out of 10 on a visual analogue scale; ii) systemic inflammatory joint disease (including rheumatoid arthritis, polymyalgia rheumatica); iii) radiological evidence of osteoarthritis of the shoulder or fracture; iv) calcification about the shoulder joint; v) reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound); vi) contraindications to arthrogram and/or hydrodilatation such as current warfarin therapy; allergy to local anaesthetic or iodinated contrast; vii) pregnancy; viii) likely not to attend for physiotherapy sessions or comply with follow up; ix) inability to partake in moderate exercise, x) previous post-hydrodilatation physiotherapy program; xi) lack of written informed consent.

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 concealment was held by the practice manager of the central physiotherapy centre. Patients were randomised immediately prior to treatment by telephone call.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Uneven block randomisation according to computer generated table of random numbers after stratification by physiotherapist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 991 0
Government body
Name [1] 991 0
NHMRC Project Grant 194417
Address [1] 991 0
Country [1] 991 0
Australia
Funding source category [2] 992 0
Charities/Societies/Foundations
Name [2] 992 0
Arthritis Australia
Address [2] 992 0
Country [2] 992 0
Australia
Funding source category [3] 993 0
Other
Name [3] 993 0
Cabrini Education and Research Institute
Address [3] 993 0
Country [3] 993 0
Australia
Primary sponsor type
University
Name
The Monash Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Epidemiology, Monash University initiated and managed the trial.
Address
Country
Australia
Secondary sponsor category [1] 855 0
None
Name [1] 855 0
N/A
Address [1] 855 0
Country [1] 855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2297 0
Monash University
Ethics committee address [1] 2297 0
Ethics committee country [1] 2297 0
Australia
Date submitted for ethics approval [1] 2297 0
Approval date [1] 2297 0
Ethics approval number [1] 2297 0
Ethics committee name [2] 2298 0
Cabrini Hospital
Ethics committee address [2] 2298 0
Ethics committee country [2] 2298 0
Australia
Date submitted for ethics approval [2] 2298 0
Approval date [2] 2298 0
Ethics approval number [2] 2298 0

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

Contacts
Principal investigator
Name 35695 0
Address 35695 0
Country 35695 0
Phone 35695 0
Fax 35695 0
Email 35695 0
Contact person for public queries
Name 9917 0
Associate Professor Rachelle Buchbinder
Address 9917 0
Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 9917 0
Australia
Phone 9917 0
+61 3 95081652
Fax 9917 0
+61 3 95081653
Email 9917 0
rachelle.buchbinder@med.monash.edu.au
Contact person for scientific queries
Name 845 0
Associate Professor Rachelle Buchbinder
Address 845 0
Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 845 0
Australia
Phone 845 0
+61 3 95081652
Fax 845 0
+61 3 95081653
Email 845 0
rachelle.buchbinder@med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary