Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000400268
Ethics application status
Approved
Date submitted
1/06/2009
Date registered
2/06/2009
Date last updated
2/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multimodal Manipulative Therapy for Shoulder Pain
Scientific title
A Randomised Controlled Clinical Trial of Multimodal Manipulative Therapy for Shoulder Pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 4888 0
Condition category
Condition code
Musculoskeletal 237243 237243 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manipulation, soft tissue procedures, rehabilitation exercises.
The active therapeutics include a combination of manipulation, soft tissue therapy and rehabilitation exercises (multimodal therapy)
Manipulation involves a high velocity low amplitude procedure directed at either the low cervical spine, upper thoracic spine, glenohumeral or acromioclavicluar joints dependent on clinical finings i.e. detection of manipulable lesion or fixated joint.
Soft tissue therapy includes ischaemic pressure massage administered to tight or spasmed muscles and tight muscle stretches.
Rehabilitation exercises including isometric followed by isotonic strengthening exercies directed at the rotator cuff muscles. These exercises are to be performed at home by the participants.
The duraion of each treatment session is between 15-20 minutes.
Each participant will recieve a total of 8 treatments at a frequency of 2 times per week for 4 weeks.
Intervention code [1] 236676 0
Treatment: Other
Comparator / control treatment
Control group is treated with therapeutic ultrasound set at a zero setting.
The control group will recieve a sham intervention where the ultrasound unit is switched on but with zero (non therapeutic settings on the unit).
The clinician will still use aquasonic gel and will move the transducer head over the area of the shoulder to be treated for a total of 15 minutes.
The treatment frequency is the same as the active therapeutic; total of 8 treatments, 2 times a week for 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 238056 0
Visual analogue scale (VAS) pain levels
Orthoaedic tests
Timepoint [1] 238056 0
At baseline
At 4 weeks after therapy completion
At 4 months after therapy completion
Secondary outcome [1] 242243 0
Orthopaedic range of motion
All ranges of motion of the glenohumeral joint and cervical spine will be measured.
Measurement will be conducted by a blinded research assistant with a hand held goniometer and pleurimeter.
Measurements taken at baseline, at 4 weeks after treatment completion and at 4 months after treatment completion
Timepoint [1] 242243 0
At baseline
At 4 weeks after therapy completion
At 4 months after therapy completion

Eligibility
Key inclusion criteria
Presence of shoulder pain in the anterior , lateral and posterior aspects of the shoulder inclduing the low cervical spine
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any yellow and red flag symptoms

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)
Enrollment via newspaper advertisments
Prescreening telephone interview to determine suitability for the trial and the presence of inclusion and exclusion criteria.
Allocation of participants to treatment groups performed by the blinded research assistant, all the names of the participants were placed in a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was accomplished
by utilising 45 folded sheets of paper
(15 marked multimodal, 15 marked manipulation group and 15 marked control group) thoroughly
mixed together to assure discontinuity
and then placed in a hat. At each participation randomisation
timepoint, the hat was held so that
all folded slips were completely obscured.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
To show that the study and interventions are safe and effective
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5067 0
Self funded/Unfunded
Name [1] 5067 0
Mario Pribicevic
Country [1] 5067 0
Australia
Primary sponsor type
Individual
Name
Mario Pribicevic
Address
91 Bennett St, Curl Curl 2096 NSW
Country
Australia
Secondary sponsor category [1] 4575 0
None
Name [1] 4575 0
Address [1] 4575 0
Country [1] 4575 0
Other collaborator category [1] 697 0
University
Name [1] 697 0
Assoc Pro Henry Pollard
Address [1] 697 0
Department of Chiropractic
Faculty of Science
Macquarie University, Ryde 2109 NSW
Country [1] 697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239168 0
Ethics Review Committee (human Research)
Ethics committee address [1] 239168 0
Ethics committee country [1] 239168 0
Australia
Date submitted for ethics approval [1] 239168 0
Approval date [1] 239168 0
28/11/2003
Ethics approval number [1] 239168 0
HE28nov2003-no2727

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

Contacts
Principal investigator
Name 29674 0
Address 29674 0
Country 29674 0
Phone 29674 0
Fax 29674 0
Email 29674 0
Contact person for public queries
Name 12921 0
Mario Pribicevic
Address 12921 0
91 Bennett St, Curl Curl 2096 NSW
Country 12921 0
Australia
Phone 12921 0
+61 2 99386623
Fax 12921 0
Email 12921 0
[email protected]
Contact person for scientific queries
Name 3849 0
Mario Pribicevic
Address 3849 0
91 Bennett St, Curl Curl 2096 NSW
Country 3849 0
Australia
Phone 3849 0
+61 2 99386623
Fax 3849 0
Email 3849 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.