NCT05200689

Brief Summary

The project is of a comparative nature. It seeks to study pain reduction following two forms of chest surgery and compare results between both procedures. It will use kinesio taping as the studied pain reducer. It will involve 4 study groups, 2 per surgical procedure, and among those 2 main groups, 2 subgroups each where 1 has kinesio taping and the other doesn't. With this, the project hopes to offer new forms of pain reduction that are more cost effective and are associated with less adverse effects. Furthermore it would decrease pain killer intake which is a contemporary challenge of medicine.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 20, 2021

Last Update Submit

January 20, 2022

Conditions

Post Operative Pain

Keywords

KinesiotapingPostoperative PainThoracic SurgeryComparativeUniportal VATSAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain: Change in VAS Pain Scale

    Degree of change in postoperative pain. It will be measured 5 times. Postoperative pain will be measured via the VAS pain scale. It will also be estimated based on the patients' request for further analgesia. The VAS Scale stands for: Visual Analog Scale. Minimum Score: 0 Maximum Score: 100 Higher scores signify worse pain and thus a worse outcome.

    21 days

Study Arms (4)

Thoracotomy, KT

EXPERIMENTAL

Patients in this group will undergo the same analgesia protocol as other groups. They will undergo the thoracotomy protocol, alongside the KT protocol.

Device: Kinesiotaping (KT)

Thoracoscopy, KT

EXPERIMENTAL

Patients in this group will undergo the same analgesia protocol as other groups. They will undergo the thoracoscopy protocol, alongside the KT protocol.

Device: Kinesiotaping (KT)

Thoracotomy, Non-KT

NO INTERVENTION

Patients in this group will undergo the same analgesia protocol as other groups. They will undergo the thoracotomy protocol, without the KT protocol.

Thoracoscopy, Non-KT

NO INTERVENTION

Patients in this group will undergo the same analgesia protocol as other groups. They will undergo the thoracoscopy protocol, without the KT protocol.

Interventions

Kinesiotaping (KT)DEVICE

Kinesio taping will only be applied for a period of 5 days. Initial Kinesio taping will first occur one day after surgery. It will be placed directly on the chest wall on a trigger point. Physiotherapists will be instructed to maintain a standard Tape length (To body size ratio) and tension among all patients of all KT groups. The edges of the tape must be rounded, to prevent premature peeling. The adhesive side of the tape must not be touched after removing its backing, to prevent any decrease in tape adherence. It will be applied using both I and Star applications. Star and I KT application is done directly above the main pain trigger point. This point is found via chest palpitations. The Tape will be replaced every 48 hours by the physiotherapist until the end of therapy. The tape must be placed after stretching the skin.

Also known as: Kinesio Tex Gold, K-active kinesiology tape
Thoracoscopy, KTThoracotomy, KT

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Single port VATS thoracoscopies
  • Patients that undergo thoracotomy or thoracoscopy at associated centers
  • Patients within the age range (18-64) years.

You may not qualify if:

  • Preexisting conditions
  • Certain surgical complication
  • KT and analgesics-related contraindications
  • Patients that offer logistic difficulties.
  • Patients that suffer from recent chest trauma (Within 6 months), pre-existing chest pain
  • Rib resection, pleuralesis, parietal pleura involvement in the surgery
  • Surgeries with increased involvement of the chest, vertebrobasilar insufficiency
  • Inflammatory diseases
  • Neurologic diseases
  • Congenital diseases
  • Fractures, dislocations, infections
  • Dural perforations, spinal cord damage with abscess development due to nerve block
  • Patients who have contraindications to KT, especially those who suffer from DVT (DVT: Deep Vein Thrombosis), skin Pathologies, and diseases, especially relating to the chest area
  • Patient with congestive heart failure
  • Patients that experience skin sensitivity or allergy to the Kinesio taping
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Assiut Uniersity

Asyut, Egypt

NOT YET RECRUITING

Tanta University

Tanta, Egypt

NOT YET RECRUITING

European Institute of Oncology

Milan, Italy

NOT YET RECRUITING

Al-Makased Hospital

East Jerusalem, Palestinian Territories

RECRUITING

Royal Papworth Hospital

Cambridge, United Kingdom

NOT YET RECRUITING

Related Publications (22)

  • Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359.

    PMID: 23649443RESULT

  • Kurt Saruhan H, Toprak M. Pain-diminishing and quality of life-related outcomes of Kinesio taping in patients on non-steroidal anti-inflammatory drug therapy for post-thoracotomy pain syndrome. Turk J Phys Med Rehabil. 2020 May 18;66(2):147-153. doi: 10.5606/tftrd.2020.4068. eCollection 2020 Jun.

    PMID: 32760891RESULT

  • Alzahrani T. Pain relief following thoracic surgical procedures: A literature review of the uncommon techniques. Saudi J Anaesth. 2017 Jul-Sep;11(3):327-331. doi: 10.4103/sja.SJA_39_17.

    PMID: 28757835RESULT

  • Zeng R, Tian K, Xiao Z. Effectiveness of thoracic kinesio taping on respiratory function and muscle strength in patients with chronic obstructive pulmonary disease: A protocol of randomized, double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Apr 9;100(14):e25269. doi: 10.1097/MD.0000000000025269.

    PMID: 33832089RESULT

  • Imperatori A, Grande A, Castiglioni M, Gasperini L, Faini A, Spampatti S, Nardecchia E, Terzaghi L, Dominioni L, Rotolo N. Chest pain control with kinesiology taping after lobectomy for lung cancer: initial results of a randomized placebo-controlled study. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):223-30. doi: 10.1093/icvts/ivw110. Epub 2016 Apr 29.

    PMID: 27130717RESULT

  • Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

    PMID: 18456219RESULT

  • Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.

    PMID: 27160473RESULT

  • Laursen LO, Petersen RH, Hansen HJ, Jensen TK, Ravn J, Konge L. Video-assisted thoracoscopic surgery lobectomy for lung cancer is associated with a lower 30-day morbidity compared with lobectomy by thoracotomy. Eur J Cardiothorac Surg. 2016 Mar;49(3):870-5. doi: 10.1093/ejcts/ezv205. Epub 2015 Jun 18.

    PMID: 26088592RESULT

  • Luz Junior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping(R) is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial. Braz J Phys Ther. 2015 Nov-Dec;19(6):482-90. doi: 10.1590/bjpt-rbf.2014.0128. Epub 2015 Oct 9.

    PMID: 26647750RESULT

  • Ristow O, Pautke C, Victoria Kehl, Koerdt S, Schwarzler K, Hahnefeld L, Hohlweg-Majert B. Influence of kinesiologic tape on postoperative swelling, pain and trismus after zygomatico-orbital fractures. J Craniomaxillofac Surg. 2014 Jul;42(5):469-76. doi: 10.1016/j.jcms.2013.05.043. Epub 2013 Jul 4.

    PMID: 23830769RESULT

  • Laborie M, Klouche S, Herman S, Gerometta A, Lefevre N, Bohu Y. Inefficacy of Kinesio-Taping((R)) on early postoperative pain after ACL reconstruction: Prospective comparative study. Orthop Traumatol Surg Res. 2015 Dec;101(8):963-7. doi: 10.1016/j.otsr.2015.09.025. Epub 2015 Nov 14.

    PMID: 26589192RESULT

  • Parreira Pdo C, Costa Lda C, Hespanhol LC Jr, Lopes AD, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. J Physiother. 2014 Mar;60(1):31-9. doi: 10.1016/j.jphys.2013.12.008. Epub 2014 Apr 24.

    PMID: 24856938RESULT

  • Elabd AM, Ibrahim AR, Elhafez HM, Hussien HA, Elabd OM. Efficacy of Kinesio Taping and Postural Correction Exercises on Levator Scapula Electromyographic Activities in Mechanical Cervical Dysfunction: A Randomized Blinded Clinical Trial. J Manipulative Physiol Ther. 2020 Jul-Aug;43(6):588-596. doi: 10.1016/j.jmpt.2019.05.010. Epub 2020 Jul 21.

    PMID: 32709516RESULT

  • Krajczy M, Bogacz K, Luniewski J, Szczegielniak J. The influence of Kinesio Taping on the effects of physiotherapy in patients after laparoscopic cholecystectomy. ScientificWorldJournal. 2012;2012:948282. doi: 10.1100/2012/948282. Epub 2012 May 3.

    PMID: 22645478RESULT

  • Ulu M, Gozluklu O, Kaya C, Unal N, Akcay H. Three-Dimensional Evaluation of the Effects of Kinesio Taping on Postoperative Swelling and Pain after Surgically Assisted Rapid Palatal Expansion. J Oral Maxillofac Res. 2018 Dec 30;9(4):e3. doi: 10.5037/jomr.2018.9403. eCollection 2018 Oct-Dec.

    PMID: 30746052RESULT

  • Chan MC, Wee JW, Lim MH. Does Kinesiology Taping Improve the Early Postoperative Outcomes in Anterior Cruciate Ligament Reconstruction? A Randomized Controlled Study. Clin J Sport Med. 2017 May;27(3):260-265. doi: 10.1097/JSM.0000000000000345.

    PMID: 27428680RESULT

  • Brockmann R, Klein HM. Pain-diminishing effects of Kinesio(R) taping after median sternotomy. Physiother Theory Pract. 2018 Jun;34(6):433-441. doi: 10.1080/09593985.2017.1422205. Epub 2018 Jan 8.

    PMID: 29308962RESULT

  • Nobel TB, Adusumilli PS, Molena D. Opioid use and abuse following video-assisted thoracic surgery (VATS) or thoracotomy lung cancer surgery. Transl Lung Cancer Res. 2019 Dec;8(Suppl 4):S373-S377. doi: 10.21037/tlcr.2019.05.14. No abstract available.

    PMID: 32038918RESULT

  • Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.

    PMID: 18713924RESULT

  • Guner S, Alsancak S, Koz M. Effect of two different kinesio taping techniques on knee kinematics and kinetics in young females. J Phys Ther Sci. 2015 Oct;27(10):3093-6. doi: 10.1589/jpts.27.3093. Epub 2015 Oct 30.

    PMID: 26644651RESULT

  • Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.

    PMID: 2213777RESULT

  • Joyce CR, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. Eur J Clin Pharmacol. 1975 Aug 14;8(6):415-20. doi: 10.1007/BF00562315.

    PMID: 1233242RESULT

Related Links

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Peter R. Bael

    Al-Quds University

    PRINCIPAL INVESTIGATOR

  • Raya Amro

    Al-Quds University

    PRINCIPAL INVESTIGATOR

  • Mayar Idkedek

    Al-Quds University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Firas Abu Akar, MD

CONTACT

00972522200688firasabuakar@gmail.com

Bayan F. Al-Qtishat, MD

CONTACT

00972597579562bayan.alqtishat@students.alquds.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 21, 2022

Study Start

January 9, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)GB(1)PA(1)EG(2)