Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001172291
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
16/07/2018
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Telehealth for the treatment of chronic shoulder pain in wheelchair users with spinal cord injury: a randomised controlled trial
Scientific title
The effectiveness of Telehealth for the treatment of chronic shoulder pain in wheelchair users with spinal cord injury: a randomised controlled trial
Secondary ID [1] 295509 0
Nil known
Universal Trial Number (UTN)
U1111-1213-7262
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 308775 0
Condition category
Condition code
Neurological 307710 307710 0 0
Other neurological disorders
Injuries and Accidents 307711 307711 0 0
Other injuries and accidents
Musculoskeletal 307712 307712 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the Intervention group will receive 6 weeks of advice and a home-exercise program along with encouragement, reassurance and support delivered through an initial face-to-face session with a physiotherapist and then weekly telephone calls and text messages.

The initial face-to-face session with a physiotherapist will be of 1 to 3 hours duration. During this session, the physiotherapist will provide advice about ways to modify the environment and activities to prevent shoulder pain, and will provide encouragement, reassurance and support. The physiotherapist will also prescribe a home-exercise program using freely available web-based exercise-prescribing software (www.physiotherapyexercises.com). The exercises will then be sent to the participant’s mobile device by an App associated with the software. The types of exercises prescribed will be personalised to the needs of each participant and based on the participant’s strength, endurance, mobility and shoulder/ trunk stability as well as his/her goals. The home-exercise programs will typically comprise up to 8 shoulder strengthening exercises that will take approximately 20 minutes to complete. Participants will be required to perform their exercise 6 times a week and use the App to record exercise adherence which will be remotely monitored by the trial physiotherapist. The exercises will be progressed by either increasing the repetitions or load, or decreasing the rest time.

The text messages will be sent weekly. They will be generic messages encouraging participants to adhere to the advice and home-exercise program.

The weekly telephone calls will be made by the treating physiotherapist. They are estimated to last for between 5 and 30 minutes. During these telephone calls, the physiotherapist will provide ongoing advice, encouragement, reassurance and support. The physiotherapist will also use this opportunity to progress participants’ home-exercise programs and ensure that participants are not experiencing any problems or notable increases in symptoms. The trial physiotherapist has the option of visiting the participant in his/her home if concerned or if deemed necessary.
Intervention code [1] 301824 0
Rehabilitation
Intervention code [2] 301825 0
Treatment: Other
Comparator / control treatment
Those randomised to the Control group will not receive any treatment for their shoulder pain. They will be put on a waiting list to receive the same care provided to the Intervention group at the completion of the trial if they chose to pursue.
Control group
Active

Outcomes
Primary outcome [1] 306697 0
Wheelchair Users Shoulder Pain Index (WUSPI)
Timepoint [1] 306697 0
6 weeks from randomisation
Secondary outcome [1] 349282 0
Average shoulder pain on movement measured by the 0-10 Numerical Rating scale
Timepoint [1] 349282 0
6 weeks from randomisation
Secondary outcome [2] 349283 0
Average shoulder pain at rest measured by the 0-10 Numerical Rating scale
Timepoint [2] 349283 0
6 weeks from randomisation
Secondary outcome [3] 349284 0
Average interference with ADL measured by the 0-10 Numerical Rating scale
Timepoint [3] 349284 0
6 weeks from randomisation
Secondary outcome [4] 349285 0
Canadian Occupational Performance Measure - Performance (COPM - Performance)
Timepoint [4] 349285 0
6 weeks from randomisation
Secondary outcome [5] 349286 0
Canadian Occupational Performance Measure - Satisfaction (COPM - Satisfaction)
Timepoint [5] 349286 0
6 weeks from randomisation
Secondary outcome [6] 349287 0
Patient Global Impression of Change (PGIC) – strength
Timepoint [6] 349287 0
6 weeks from randomisation
Secondary outcome [7] 349288 0
Patient Global Impression of Change (PGIC) – pain
Timepoint [7] 349288 0
6 weeks from randomisation
Secondary outcome [8] 349289 0
Participant satisfaction with healthcare service delivery. Participants will be asked the following question: “How satisfied have you been with the care you have received for the management of your shoulder pain over the last 6 weeks?” Participants will be instructed to rate their satisfaction on a 0-10 visual analogue scale where 0 indicates“not at all satisfied” and 10 indicates “extremely satisfied”.
Timepoint [8] 349289 0
6 weeks from randomisation
Secondary outcome [9] 349302 0
World Health Organization Quality of Life-BREF scale (WHOQOL-BREF)
Timepoint [9] 349302 0
6 weeks from randomisation

Eligibility
Key inclusion criteria
People with spinal cord injuries will be included if they:
• have any neurological level (as defined by the International Standards for Neurological classification of SCI) sustained more than 3 months prior to baseline testing and provided they had an upper motor score equal to or greater than 10 and/or sufficient upper limb strength to engage in active exercise
• have unilateral or bilateral shoulder pain that has been present for 3 months or longer
• are over 16 years of age and are able to provide informed consent
• are willing to participate in the trial
• do not have any other type of neurological lesion
• are living in the community
• are wheelchair dependent
• have access to and are able to use a phone, cell phone and internet
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they:
• have had shoulder surgery
• have pain radiating to cervical area
• have a suspected serious shoulder problem that could not reasonably be managed by remotely-provided treatment (e.g. for example, suspected complete rotator cuff tear, substantial shoulder weakness high riding humerus on plain radiograph, or very severe shoulder pain
• are unlikely or unwilling to co-operate
• unable to speak Portuguese
• currently receiving physiotherapy or any other type of therapy for their shoulder pain and/ or are likely to seek treatment in the next 6 weeks

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)
Staff determining a participant's eligibility to a trial will not have access to the randomisation schedule. The staff member will determine suitability and then request randomisation from an independent and off-site person. A participant will be entered into the trial when baseline details are logged at the central site and the allocation is provided. The person responsible for central randomisation will notify the trial staff of participants’ allocation by email. Trial staff will then notify the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure random-allocation schedule will be computer-generated prior to commencement of the trial by an independent person and kept at a central off-site location. The randomisation schedule will not be stratified, but will be blocked (1:1) ensuring equal numbers of participants are randomised to the Intervention and Control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be done using the principles of ‘intention to treat’. Between-group comparisons of continuous data will be conducted using regression models in which the outcome will be a linear function of a dummy-coded variable representing group membership (Intervention or Control group). Baseline scores will be included in the model to increase statistical precision. The dependent variables in the linear regression analyses will be transformed to approximate a normal distribution where necessary and possible. Alternatively, it may be necessary to use a median regression model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
12/09/2019
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 10637 0
Brazil
State/province [1] 10637 0
Brasilia

Funding & Sponsors
Funding source category [1] 300092 0
University
Name [1] 300092 0
The University of Sydney
Country [1] 300092 0
Australia
Funding source category [2] 300094 0
University
Name [2] 300094 0
Universidade de Brasília
Country [2] 300094 0
Brazil
Primary sponsor type
University
Name
Universidade de Brasília
Address
Universidade de Brasília, Campus de Ceilândia, Faculdade de Ceilândia, Programa de Pós-Graduação em Ciências e Tecnologias em Saúde
Country
Brazil
Secondary sponsor category [1] 299493 0
University
Name [1] 299493 0
University of Sydney
Address [1] 299493 0
John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute, C/- Royal North Shore Hospital, St Leonards, NSW, 2065, Australia
Country [1] 299493 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300939 0
UnB - Faculdade De Ceilândia Da Universidade De Brasília
Ethics committee address [1] 300939 0
UnB - Prédio da Unidade de Ensino e Docência (UED), Centro Metropolitano, conj. A, lote 01, Sala AT07/66 - Brasília - Distrito Federal
Ethics committee country [1] 300939 0
Brazil
Date submitted for ethics approval [1] 300939 0
Approval date [1] 300939 0
04/05/2018
Ethics approval number [1] 300939 0
2.636.339

Summary
Brief summary
The trial is a pragmatic single-centre, single-blinded between-participant randomised controlled trial. The primary aim is to determine the effect of advice and a home-exercise programme delivered through an App, text messages and weekly telephone contact versus no intervention on chronic shoulder pain during performance of daily activities in wheelchair users with spinal cord injury (SCI). Eligible participants will be randomised to one of two groups, either the Intervention group or the Control group. Participants randomised to the Intervention group will receive advice and a home-exercise program along with encouragement, reassurance and support delivered through an App, text messages and weekly telephone contact for 6 weeks. The only interaction with a physiotherapist will be at an initial face-to-face session and then weekly contact over the telephone. Participants randomised to the Control group will receive no treatment for their shoulder pain. There will be one primary and nine secondary outcomes measured by blinded assessors at 6 weeks. The primary outcome will be the Wheelchair Users Shoulder Pain Index.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85350 0
Mr Paulo Henrique Ferreira de Araujo Barbosa
Address 85350 0
Universidade de Brasília, Campus de Ceilândia, Faculdade de Ceilândia, Programa de Pós-Graduação em Ciências e Tecnologias em Saúde
Country 85350 0
Brazil
Phone 85350 0
+5561982523198
Fax 85350 0
Email 85350 0
[email protected]
Contact person for public queries
Name 85351 0
Mr Paulo Henrique Ferreira de Araujo Barbosa
Address 85351 0
Universidade de Brasília, Campus de Ceilândia, Faculdade de Ceilândia, Programa de Pós-Graduação em Ciências e Tecnologias em Saúde
Country 85351 0
Brazil
Phone 85351 0
+5561982523198
Fax 85351 0
Email 85351 0
[email protected]
Contact person for scientific queries
Name 85352 0
Prof Lisa Harvey
Address 85352 0
John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute, C/- Royal North Shore Hospital, St Leonards, NSW, 2065
Country 85352 0
Australia
Phone 85352 0
+61 2 9926 4594
Fax 85352 0
Email 85352 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.