A pilot study: a randomised controlled trial investigating the effect of therapeutic ultrasound and exercise on active digital flexion following phalangeal fractures

ISRCTN	ISRCTN79669268
DOI	https://doi.org/10.1186/ISRCTN79669268
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Sue Kennedy
Scientific

Physiotherapy Outpatient Department
Derbyshire Royal Infirmary
London road
Derby
DE1 2QY
United Kingdom

Study design	Randomised, double-blind, placebo-controlled
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Added as of 18/06/2008: Nottingham Research Ethics Committee 1. Date of approval: 22/05/2007 (ref: 06/Q2403/42)
Health condition(s) or problem(s) studied	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
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 study start date	27/02/2006
Completion date	17/07/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	27/02/2006
Date of final enrolment	17/07/2006

Physiotherapy Outpatient Department

Derby
DE1 2QY
United Kingdom

Derby University (UK)
University/education

The Cedars
138 Whitaker road
Derby
DE23 6AP
England
United Kingdom

"ROR"	https://ror.org/02yhrrk59

Government

Trent Workforce Confederation, Derby Hospitals NHS Foundation Trust (UK)

No information available

Chartered Society of Physiotherapy (UK)

No information available

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