Physiotherapy in conservatively managed distal radius fractures
| ISRCTN | ISRCTN62731680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62731680 |
| Secondary identifying numbers | 19314 |
- Submission date
- 19/11/2015
- Registration date
- 19/11/2015
- Last edited
- 13/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Three-arm prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | East Midlands - Nottingham 2 Research Ethics Committee, 30/07/2015, ref: 15/EM/0297 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 12/10/2015 |
| Completion date | 01/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Total final enrolment | 120 |
| Key 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 |
| Key exclusion criteria | 1. A fracture which extends beyond 3 cm 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 |
| Date of first enrolment | 12/10/2015 |
| Date of final enrolment | 01/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/05y3qh794 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 13/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/05/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
