Condition category
Musculoskeletal Diseases
Date applied
19/11/2015
Date assigned
19/11/2015
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Miss Jessica Nightingale

ORCID ID

Contact details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

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

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes