Plain English Summary
Background and study aims
A distal radius fracture, commonly referred to as a broken wrist, is where bone running between the elbow and the thumb (radius) is broken. It can be extremely painful, making it difficult or even impossible to use the affected arm. If the break is “clean” and the broken pieces of bone are in the correct position, then they are usually treated by applying a plaster or fibreglass cast. This works by holding the broken sections of bone together so that they heal in the right position (immobilisation). The cast usually stays in place for at least 6 weeks, to give the bones a chance to heal. Once the cast is removed, many doctors recommend physiotherapy, to help restore strength in the arm muscles and to restore full movement. Physiotherapy is not always available and can be very expensive however, and many health professionals do not feel that it is a necessary part of recovery for those with a broken wrist. It can be argued that many patients could benefit equally well from managing their rehabilitation themselves, such as through self-directed exercises at home. The aim of this study is to compare the long-term effects of having physiotherapy to self-directed exercises on long-term recovery following a distal radius fracture.
Who can participate?
Adults who have had a broken wrist treated using a cast or splint for between 5-7 weeks.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are given an advice sheet including information about the process of recovery. Those in the second group are given an outpatient appointment with a physiotherapist. Those in the third group are provided with a video that they can watch at home, and will instruct them how to perform rehabilitation exercises that may help their recovery. At the start of the study and then at 6, 12 and 52 weeks, participants complete a number of questionnaires in order to monitor their recovery.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Queens Medical Centre, Nottingham (UK)
When is the study starting and how long is it expected to run for?
October 2015 to August 2017
Who is funding the study?
AOUK (UK)
Who is the main contact?
Miss Jessica Nightingale
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19314
Study information
Scientific title
Outcomes and cost effectiveness of physiotherapy, self directed therapy and advice sheets following conservatively managed distal radius fractures: A prospective randomised controlled trial
Acronym
Study hypothesis
The aim of this study is to investigate the effects of physiotherapy, self directed therapy and advice sheets on recovery following a distal radial fracture.
Ethics approval
East Midlands - Nottingham 2 Research Ethics Committee, 30/07/2015, ref: 15/EM/0297
Study design
Three-arm prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Participants are randomly allocated to one of three groups.
Group 1: Participants are given an advice sheet and a physiotherapy department leaflet (control group)
Group 2: Participants are provided with an outpatient appointment with physiotherapist
Group 3: Participants are provided with an instructional video that will help them to perform rehabilitation exercises at home.
Participants recovery is assessed at baseline, 6, 12 and 52 weeks for all groups.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Symptoms and ability in the affected arm are measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at baseline, 6 , 12 and 52 weeks.
Secondary outcome measures
1. EQ5D at baseline, 6 , 12 and 52 weeks
2. Patient Evaluation Measure (PEM) at baseline, 6, 12 and 52 weeks
3. Routine Outcome Measures (ROM) at 6, 12 and 52 weeks
Overall trial start date
12/10/2015
Overall trial end date
01/08/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 70 years at the time of fracture
2. Able to give informed consent
3. Any fracture of the distal radius within 3cm of the radiocarpal joint will be considered for inclusion (including intraarticular fractures, fractures with comminution, associated ulnar styloid fracture, dorsal and volar displacement patterns) provided it has been deemed suitable for conservative management by the treating physician.
4. Fracture treated with immobilisation (plaster of paris / fibreglass cast / splint) worn constantly for between 5 and 7 weeks
5. English should be the patient's first language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. A fracture which extends beyond 3cm of the radiocarpal joint
2. Any patient with bilateral fractures
3. A fracture which has been immobilised outside of the range of 5 and 7 weeks
4. Any patient who is deemed to be unlikely to be able to adhere to the trial procedure or complete the questionnaires (e.g. drug dependence or cognitive impairment)
5. Current participation in another ongoing study
6. Evidence of complex regional pain syndrome
7. Post plaster stiffness of the fingers which prevents the patient from being able to place their hand flat on a tabletop
8. Any previous fracture of the wrist or carpal bones whether treated operatively or conservatively
Recruitment start date
12/10/2015
Recruitment end date
01/08/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Funders
Funder type
Research organisation
Funder name
AOUK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary