Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/01/2006
Date assigned
01/03/2006
Last edited
27/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sue Kennedy

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Derby University (UK)

Sponsor details

The Cedars
138 Whitaker road
Derby
DE23 6AP
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

As of 18/06/2008: Please note that this trial was a pilot study and has been published only as an MSc dissertation.

Publication citations

Additional files

Editorial Notes