Condition category
Signs and Symptoms
Date applied
24/11/2015
Date assigned
10/12/2015
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pain relief is an important part of the care of patients who have undergone major thoracic (chest) surgery. Management of pain relief helps patients to actively perform respiratory (breathing) rehabilitation and to prevent pulmonary (lung) complications. A wide spectrum of medications and techniques for pain control is available, but the best strategy for pain management is still being debated. Kinesio Taping® is a rehabilitation method developed in the 1970s in Japan, and involves applying a specially designed drug-free elastic tape to the patient's skin. Pain control results from reducing local pressure by lifting the skin over the area of treatment. There are few studies exploring the use of Kinesio Taping in surgical patients. The aim of this study is to test the safety and effectiveness of Kinesio Taping in reducing chest pain after lung lobectomy (the removal of one lobe of the lung) to treat lung cancer.

Who can participate?
Patients undergoing lobectomy for lung cancer.

What does the study involve?
Patients are randomly allocated to be treated with either Kinesio Tape or the usual dressing tape. Tapes are applied by a specialized physiotherapist. Thoracic pain severity is self-assessed by all patients at 1, 2, 5, 8, 9 and 30 days after the operation.

What are the possible benefits and risks of participating?
The expected benefits for participants are reduction of chest pain after the operation, less need for pain relief, and shorter length of hospital stay. Local adverse events such as skin allergic reactions are the only potential risk of participating.

Where is the study run from?
The Center for Thoracic Surgery, University of Insubria (Italy)

When is the study starting and how long is it expected to run for?
January 2013 to December 2016

Who is funding the study?
Not provided at time of registration.

Who is the main contact?
Prof Andrea Imperatori
andrea.imperatori@uninsubria.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrea Imperatori

ORCID ID

http://orcid.org/0000-0001-6281-1800

Contact details

Via Guicciardini 9
Varese
21100
Italy
+39 (0)332 393 195
andrea.imperatori@uninsubria.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chest Kinesio Taping® for pain control after lobectomy for lung cancer: a randomized controlled trial

Acronym

Study hypothesis

Pain relief is a relevant component of the postoperative care of patients undergoing major thoracic surgery. Management of analgesia helps patients to actively perform respiratory rehabilitation and to prevent pulmonary complications. A wide spectrum of medications and techniques for pain control is available; however, the optimal strategy for postoperative pain management is still debated. Kinesio Taping® (KT) is a rehabilitation method developed in the 1970s in Japan, consisting of the application of a specially designed drug-free elastic tape to the patient's skin, to achieve therapeutic effects. These include lymphatic, space, functional and mechanical corrections.
Pain control results from reduction of local pressure by lifting the skin over the area of treatment. According to Kase et al., space correction by KT reduces irritation of chemoceptors, improves the circulation of blood and lymph and helps exudate re-absorption, thus reducing pain. There are few studies exploring the use of KT in surgical patients.
We test the safety and efficacy of Kinesio Taping in reducing postoperative chest pain after lung lobectomy.

Ethics approval

Ethics Committee of Ospedale di Circolo Fondazione Macchi, 12/12/2012, No. 1216

Study design

Single-center single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postoperative chest pain after lung lobectomy

Intervention

Standard postoperative analgesia are administered in both groups (paracetamol/NSAID, epidural analgesia including opioids), with supplemental analgesia i.v. boluses at patient request. On postoperative day 1 in addition, a specialized physiotherapist applies KT near the chest wound to the experimental group patients, while usual dressing tapes mimicking KT are applied as placebo to controls.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Thoracic pain severity score [visual analog scale (VAS) ranging 0–10] is self-assessed by all patients on postoperative day 1, 2, 5, 8, 9 and 30

Secondary outcome measures

1. Request for supplemental analgesia; method used to measure: categorical variable: yes if any supplemental analgesic (non-steroidal anti-inflammatory drugs (NSAID) and/or opioids) are administered at patient request, more than standard postoperative analgesia during the postoperative period (from day of surgery to the day of discharge from hospital); no if no supplemental analgesics are requested by the patient nor administered more than standard analgesia during the in-hospital postoperative period; timepoint: day of discharge from the hospital
2. Chest tube duration (days); timepoint: from day of surgery to the day of last chest tube removal
3. Morbidity; method used to measure: categorical variable: yes if any postoperative complication occurs during the postoperative period within 30 days from day of surgery; no if no postoperative complication occurs within 30 days from day of surgery; timepoint: 30th postoperative day from surgery
4. Post-operative length of stay (days); timepoint: from day of surgery to the day of discharge from hospital

Overall trial start date

01/10/2012

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing lung lobectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Age >85
2. Refusal
3. Previous exposure to Kinesio Taping
4. Recent trauma
5. Pre-existing pain or prolonged ICU treatment

Recruitment start date

01/03/2013

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Italy

Trial participating centre

University of Insubria
Center for Thoracic Surgery Via Guicciardini 9
Varese
21100
Italy

Sponsor information

Organisation

University of Insubria (Italy)

Sponsor details

Dipartimento di Scienze Chirurgiche e Morfologiche
Via Guicciardini
9
Varese
21100
Italy
+39 (0)332 393 668
segreteria.dscm@uninsubria.it

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Insubria (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish at least two manuscripts: one about methodology; one about the study results. In case of interest we plan an interim analysis publication on 31/12/2015. The final results will be published on 30/06/2017.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27130717

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.