Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Digits with fracture will have improved total active flexion following six weeks of ultrasound and a standard therapy programme when compared to digits exposed to placebo ultrasound or no ultrasound and the same programme of therapy care
Ethics approval
Added as of 18/06/2008: Nottingham Research Ethics Committee 1. Date of approval: 22/05/2007 (ref: 06/Q2403/42)
Study design
Randomised, double-blind, placebo-controlled
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Proximal and middle phalangeal fractures in digits 2-5
Intervention
Therapeutic ultrasound and standard hand therapy programme of care (including exercise, oedema control, splints and advice) versus placebo ultrasound and standard hand therapy programme of care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Active digital flexion of metacarpophalangeal (MCP), interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected and contralateral finger.
Secondary outcome measures
Pain score and a measure of flexor tendon glide of affected and contralateral finger.
Overall trial start date
27/02/2006
Overall trial end date
17/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Closed, extra-articular, proximal or middle phalangeal fractures involving digits 2-5
2. Immobilization with a zimmer splint for 14-21 days
3. Able to attend twice-weekly therapy for six weeks
4. Over 18 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Compound fractures
2. Multiple fractures within the same digit
3. Intra-articular fractures and concomitant interphalangeal joint dislocations
4. Concomitant tendon injuries
5. Patients having undergone open reduction internal fixation of the fracture
6. Patients with mental impairment
7. Patients who are unable to read or understand English
8. Patients with inflammatory arthritis, significant digital osteoarthritic joint changes or diabetes
9. Patients with a pacemaker
10. Patients with carcinoma
11. Patients with previous injury to the fractured digit
12. Patients with osteoporosis
13. Patients presenting with adhered flexor tendons post-immobilization, requiring anaesthetic block
Recruitment start date
27/02/2006
Recruitment end date
17/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physiotherapy Outpatient Department
Derby
DE1 2QY
United Kingdom
Funders
Funder type
Government
Funder name
Trent Workforce Confederation, Derby Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Chartered Society of Physiotherapy (UK)
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
Basic results (scientific)
Publication list
As of 18/06/2008: Please note that this trial was a pilot study and has been published only as an MSc dissertation.