Chest Kinesio Taping for pain control after lung lobectomy
| ISRCTN | ISRCTN37253470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37253470 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/11/2015
- Registration date
- 10/12/2015
- Last edited
- 05/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Scientific
Via Guicciardini 9
Varese
21100
Italy
 ORCID ID |
0000-0001-6281-1800 |
|---|---|
| Phone | +39 (0)332 393 195 |
| andrea.imperatori@uninsubria.it |
Study information
| Study design | Single-center single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Chest Kinesio Taping® for pain control after lobectomy for lung cancer: a randomized controlled trial |
| 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(s) | Ethics Committee of Ospedale di Circolo Fondazione Macchi, 12/12/2012, No. 1216 |
| 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 |
| Primary outcome measure | 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 study start date | 01/10/2012 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Participant inclusion criteria | Patients undergoing lung lobectomy |
| 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
Study participating centre
Via Guicciardini 9
Varese
21100
Italy
Sponsor information
University/education
Dipartimento di Scienze Chirurgiche e Morfologiche
Via Guicciardini, 9
Varese
21100
Italy
| Phone | +39 (0)332 393 668 |
|---|---|
| segreteria.dscm@uninsubria.it | |
"ROR" |
https://ror.org/00s409261 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added.
