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Trial registered on ANZCTR


Registration number
ACTRN12618000016235
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
11/01/2018
Date last updated
3/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does taping help reduce pain for patients with broken ribs?
Scientific title
The effect of kinesiotape application on pain and mobility for patients with fractured ribs: an introductory study.
Secondary ID [1] 293558 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fractured ribs 305784 0
Condition category
Condition code
Injuries and Accidents 305000 305000 0 0
Fractures
Physical Medicine / Rehabilitation 305001 305001 0 0
Physiotherapy
Respiratory 305002 305002 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kinesiotape is an elastic, adhesive, cotton-based tape. Apart from the application of taping, no other aspect of medical, nursing or allied health management will be changed. The study protocol comprises an ABAB design, where A = baseline (i.e. no taping) and B = intervention (i.e. kinesiotaping). Each phase will last 24 hours, resulting in a study duration for each participant of 4 days. During B phases, kinesiotape will be applied by one of the study investigators in the interval between 0800 and 1000 hours and removed 24 hours later. The location of the rib fracture(s) will be confirmed by review of the chest xray and/or computed tomography. The application of the kinesiotaping (50-100mm width) will be similar to that described by Sareen et al and as recommended by physiotherapy colleagues in The Netherlands. A length of tape will be applied initially over the fractured area, with ~ 50% tension, and then the tape will be extended anteriorly and posteriorly along the margins of the involved ribs (0% tension), with repeated lengths of tape as required to support the fractured ribs. Due to the ABAB design of the study, adherence to the intervention will be monitored daily by one of the investigators.
Intervention code [1] 299801 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304168 0
Self-reported pain levels using a verbal analogue scale (0 = no pain and 10 = worst pain imaginable).
Timepoint [1] 304168 0
Twice daily for the 4 days of the study period.Given the introductory nature of this study, there is, at this stage, no primary timepoint.
Secondary outcome [1] 341126 0
Respiratory complications. These will be identified by daily review of each participant's medical records and medical observation charts to detect occurrence of respiratory complications and/or escalation of respiratory therapy (e.g. need for higher inspired fraction of oxygen, antibiotics for respiratory tract infection).
Timepoint [1] 341126 0
Daily over the 4 day study period.
Secondary outcome [2] 341127 0
Skin irritation measured using a verbal analogue scale. Rated by patient and physiotherapist.
Timepoint [2] 341127 0
Daily over the 4 day study period.
Secondary outcome [3] 341128 0
Pulmonary function tests (spirometer).
Timepoint [3] 341128 0
Daily over the 4 day study period.
Secondary outcome [4] 341129 0
Analgesia type and dosage. This will be measured by review of medical records and charts to identify type of analgesia used and dosage.
Timepoint [4] 341129 0
Daily over the 4 day study period.

Eligibility
Key inclusion criteria
Admitted to the Royal Adelaide Hospital with acute (< 48 hours) rib fracture(s) and aged at least 18 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refuse consent; intubated and mechanically ventilated; non-invasive mechanical ventilation; other major medical conditions or injuries that could affect the biomechanics of the rib cage and/or application of the kinesiotape; previous skin condition in the affected area; previous history of allergy to tape; pregnancy; inability to communicate effectively and easily in English..

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
This is an introductory study to allow us to become familiar with the application of kinesiotaping and assess the ease of recruitment and best outcome measures. We are only recruiting a total of 5 patients. Analyses will be predominantly descriptive in nature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9512 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 18257 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298170 0
Hospital
Name [1] 298170 0
Royal Adelaide Hospital
Address [1] 298170 0
Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country [1] 298170 0
Australia
Primary sponsor type
Individual
Name
Simone Dafoe
Address
Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 297266 0
Individual
Name [1] 297266 0
Leigh Rushworth
Address [1] 297266 0
Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country [1] 297266 0
Australia
Secondary sponsor category [2] 297267 0
Individual
Name [2] 297267 0
Kathy Stiller
Address [2] 297267 0
Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country [2] 297267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299187 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 299187 0
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Ethics committee country [1] 299187 0
Australia
Date submitted for ethics approval [1] 299187 0
24/11/2017
Approval date [1] 299187 0
04/12/2017
Ethics approval number [1] 299187 0
R20170803 HREC/17/RAH/327

Summary
Brief summary
People in hospital with broken ribs can experience a lot of chest pain which makes it hard to take a deep breath, cough and move around. The treatment of broken ribs includes various types of pain relief and physiotherapy to improve breathing ability and help you get up and moving. However, people with broken ribs may still have pain despite this treatment. We are doing a study to see if kinesiotaping is helpful for people with broken ribs. Kinesiotape is an elastic, adhesive, cotton-based tape that is applied to the skin. Its elastic properties mean it can be stretched over the involved area to support the tissues underneath. Kinesiotape is most often used for sporting injuries (e.g. knee, shoulder), but little research has been done about its effectiveness for people with broken ribs.
While our usual practice at the Royal Adelaide Hospital has been to not use any type of taping after broken ribs, we are interested in doing a study to look at the effectiveness of kinesiotaping for people with broken ribs. This is an introductory study and if we find that kinesiotaping is beneficial and has no side effects we may consider doing a larger study in the future.
The Royal Adelaide Hospital admits approximately 100 patients per year with rib fractures. Given our relative inexperience with kinesiotaping and the heterogeneity of this patient group we do not believe a randomised controlled trial would be a practicable study design in the first instance. Instead, this introductory study will comprise a series of 5 single-subject studies using an ABAB design. Depending on the ease of recruitment, sensitivity of the outcome measures and the results, a randomised controlled trial may be considered in the future.
Two of the investigators will screen all in-patients admitted with rib fractures regarding their eligibility to participate. This screening is already part of physiotherapy routine clinical practice. For pragmatic reasons concerning the availability of the investigators and ability to follow-up with taping interventions and outcome measurements over the 4-day study period, patients will only be recruited on Mondays and Tuesdays. Any decision to exclude an otherwise eligible person will be reviewed by one of the other study investigators to minimise the potential for selection bias. When a potential participant is identified, one of the investigators will approach the person regarding participation from 0800 on that day. A written information form that explains the aims and format of the study will be supplied. Informed consent will be obtained from those willing to participate. If the patient agrees to participate, the study period will commence later that same morning.
Apart from the application of taping, no other aspect of medical, nursing or allied health management will be changed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79586 0
Ms Simone Dafoe
Address 79586 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 79586 0
Australia
Phone 79586 0
61 8 70742639
Fax 79586 0
Email 79586 0
Simone.Dafoe@sa.gov.au
Contact person for public queries
Name 79587 0
Dr Kathy Stiller
Address 79587 0
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 79587 0
Australia
Phone 79587 0
61 8 70742639
Fax 79587 0
Email 79587 0
Kathy.Stiller@sa.gov.au
Contact person for scientific queries
Name 79588 0
Dr Kathy Stiller
Address 79588 0
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 79588 0
Australia
Phone 79588 0
61 8 70742639
Fax 79588 0
Email 79588 0
Kathy.Stiller@sa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary