ANZCTR - Registration

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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

25/01/2024

Date data sharing statement initially provided

25/01/2024

Date results provided

25/01/2024

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]

None.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

fractured ribs

Condition category

Condition code

Injuries and Accidents

Fractures

Physical Medicine / Rehabilitation

Physiotherapy

Respiratory

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]

Treatment: Devices

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Self-reported pain levels using a verbal analogue scale (0 = no pain and 10 = worst pain imaginable).

Timepoint [1]

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]

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]

Daily over the 4 day study period.

Secondary outcome [2]

Skin irritation measured using a verbal analogue scale. Rated by patient and physiotherapist.

Timepoint [2]

Daily over the 4 day study period.

Secondary outcome [3]

Pulmonary function tests (spirometer).

Timepoint [3]

Daily over the 4 day study period.

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

12/02/2018

Date of last participant enrolment

Anticipated

27/03/2018

Actual

7/05/2018

Date of last data collection

Anticipated

30/03/2018

Actual

12/05/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000

Country [1]

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]

Individual

Name [1]

Leigh Rushworth

Address [1]

Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Kathy Stiller

Address [2]

Physiotherapy Department
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
Port Road
Adelaide
South  Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2017

Approval date [1]

04/12/2017

Ethics approval number [1]

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

Ms Simone Dafoe

Address

Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000

Country

Australia

Phone

61 8 70742639

Fax

Simone.Dafoe@sa.gov.au

Contact person for public queries

Name

Kathy Stiller

Address

Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000

Country

Australia

Phone

61 8 70742639

Fax

Kathy.Stiller@sa.gov.au

Contact person for scientific queries

Name

Kathy Stiller

Address

Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000

Country

Australia

Phone

61 8 70742639

Fax

Kathy.Stiller@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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