None listed
Conditions
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.
Interventions
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 s
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.
Sponsors
Universidade de Brasília
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed