Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000680965
Ethics application status
Approved
Date submitted
19/06/2011
Date registered
5/07/2011
Date last updated
5/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The rehabilitation of glenohumeral Range of Motion in Patients with Frozen Shoulder: A Comparison Between Conventional Therapy, Placebo and 'SCENAR' Electrical Stimulation Therapy.
Scientific title
The rehabilitation of glenohumeral Range of Motion in Patients with Frozen Shoulder: A Comparison Between Conventional Therapy, Placebo and 'SCENAR' Electrical Stimulation Therapy.
Secondary ID [1] 260110 0
Nil
Universal Trial Number (UTN)
U1111-1121-1594
Trial acronym
'SCENAR' Self Controlled Energy Neurological Adaptive Device
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frozen Shoulder 265786 0
Condition category
Condition code
Musculoskeletal 265940 265940 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 268367 268367 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SCENAR electrical stimulation therapy.
1 X 30 minute treatment sessions on the shoulder joint per week for 12 weeks. SCENAR is administered in a setting similar to massage therapy, with the patient sitting or lying on a massage table. The device is then placed on the patients skin and moved around the area of the injury. During this the patient may feel a slight tingling sensation.

SCENAR Placebo stimulation therapy.
1 X 30 minute treatment sessions on the shoulder joint per week for 12 weeks. This treatment will be exactly the same as SCENAR therapy, excpet that the patient will not feel a slight tingling sensation, this is a custom made placebo device that turns on but does not emit any electrical signal. The patients be assured that some people are more sensitive than others and may or may not feel anything during treatment.
Intervention code [1] 264526 0
Rehabilitation
Comparator / control treatment
Previous research conducted on the conventional therapies for the rehabilitation of frozen shoulder will be used as a control for the average recovery time.
Conventional therapies include:
Acupuncture
Massage
Arthroscopy/Manipulation Under Anaesthesia
Historial data was obtained from a literature undertaken using studies invloving conventional therapies that were completed between 2000-2011
Control group
Historical

Outcomes
Primary outcome [1] 266693 0
Shoulder range of motion.
The Constant Shoulder Score and the Shoulder Assessment Form will be used.
Timepoint [1] 266693 0
After weeks 1, 4, 8 and 12, measurements will be taken.
Secondary outcome [1] 276229 0
To measure changes in pain and quality of life during recovery using, SF (Specific Function)-36 PIQ (Pain Impact Questionnaire)-6.
Timepoint [1] 276229 0
After weeks 1, 4, 8 and 12, measurements will be taken.

Eligibility
Key inclusion criteria
Patients must present with frozen shoulder.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Pacemakers, Tumours, Any cognitive impairment, intellectual disability or mental illness that affects their ability to understand written and verbal instructions.

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)
After initial contact is made with the potential participant a meeting is then arranged. During the meeting the research project is explained to the participants, what their role is and what they are required to do. If they wish to proceed then the participant then completes the informed consent and medical forms. Once the individual meets with the practitioner they will be allocated to a randommly assigned. Allocation is not concealed from the practitioner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to groups using a sequence of numbers generated by www.random.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3999 0
4556

Funding & Sponsors
Funding source category [1] 265026 0
University
Name [1] 265026 0
University of the sunshine Coast
Country [1] 265026 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
Sippy Downs Drive,
Sippy Downs, QLD, 4556
Country
Australia
Secondary sponsor category [1] 264124 0
None
Name [1] 264124 0
Address [1] 264124 0
Country [1] 264124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267017 0
University of the Sunshine Coast Ethics Committee
Ethics committee address [1] 267017 0
Sippy Downs Drive,
Sippy Downs, QLD, 4556
Ethics committee country [1] 267017 0
Australia
Date submitted for ethics approval [1] 267017 0
18/04/2011
Approval date [1] 267017 0
03/05/2011
Ethics approval number [1] 267017 0
S/11/343

Summary
Brief summary
What is the effect of 12 weeks of SCENAR electrical stimulation therapy on glenohumeral range of motion in subjects with frozen shoulder?
As no literature exists relating specifically to SCENAR therapy, the null hypothesis is supported. This is that the device does not cause any changes to glenohumeral ROM.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32570 0
Address 32570 0
Country 32570 0
Phone 32570 0
Fax 32570 0
Email 32570 0
Contact person for public queries
Name 15817 0
Dr Dale Lovell
Address 15817 0
University of the Sunshine Coast
Sippy Downs Drive,
Sippy Downs, QLD, 4556
Country 15817 0
Australia
Phone 15817 0
+61754594464
Fax 15817 0
Email 15817 0
[email protected]
Contact person for scientific queries
Name 6745 0
Dr Dale Lovell
Address 6745 0
University of the Sunshine Coast
Sippy Downs Drive,
Sippy Downs, QLD, 4556
Country 6745 0
Australia
Phone 6745 0
+61754594464
Fax 6745 0
Email 6745 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.