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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04622137
Other study ID # Kinesiotaping Therapy
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date January 2021

Study information

Verified date November 2020
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter prospective randomized controlled study. Forty patients in whom conservative treatment for clavicle midshaft fractures was indicated between January 2018 and July 2019 were included. The investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. The investigators hypothesized that kinesiotaping reduces the disadvantages of conservative treatment, such as early-phase pain, high nonunion rates, and a prolonged time to return to work, and yields better clinical and functional outcomes by providing good mechanical support and neutralizing the deforming muscle forces around the fractured clavicle.


Description:

The investigators divided into 2 groups and followed one group of patients with clavicle fractures only with shoulder sling, while the other group were followed with kinesiotherapy treatment and shoulder arm sling. They investigated the effect of kinesiotherapy treatment on early pain and returning time to work.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: Participants with midclavicle fracture within 24 hours Exclusion Criteria: Participants with open fractures,

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Kinesiotaping therapy
The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.

Locations

Country Name City State
Turkey SBU Prof. Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (23)

Akça AH, Sasmaz MI, Kaplan S. Kinesiotaping for isolated rib fractures in emergency department. Am J Emerg Med. 2020 Mar;38(3):638-640. doi: 10.1016/j.ajem.2019.11.049. Epub 2019 Dec 20. — View Citation

Alexander CM, Stynes S, Thomas A, Lewis J, Harrison PJ. Does tape facilitate or inhibit the lower fibres of trapezius? Man Ther. 2003 Feb;8(1):37-41. — View Citation

Burnham JM, Kim DC, Kamineni S. Midshaft Clavicle Fractures: A Critical Review. Orthopedics. 2016 Sep 1;39(5):e814-21. doi: 10.3928/01477447-20160517-06. Epub 2016 May 25. Review. — View Citation

Caglar A, Pekyavas NO, Tigli AA, Aytar A, Baltaci G. Are the Kinesio Tape colors effective for patient perception? A randomized single blind trial. J Exerc Ther Rehabil 2016;3:96-101.

Craig EV. Fractures of the Clavicle. In: Rockwood CA, Green DP, Bucholz RW, Heckman JD, Editors. Rockwood and Green's Fractures in Adults. Philadelphia, PA: Lippincott- Raven; 1996. p. 1109-1161.

Ersen A, Atalar AC, Birisik F, Saglam Y, Demirhan M. Comparison of simple arm sling and figure of eight clavicular bandage for midshaft clavicular fractures: a randomised controlled study. Bone Joint J. 2015 Nov;97-B(11):1562-5. doi: 10.1302/0301-620X.97B11.35588. — View Citation

Figueiredo GS, Tamaoki MJ, Dragone B, Utino AY, Netto NA, Matsumoto MH, Matsunaga FT. Correlation of the degree of clavicle shortening after non-surgical treatment of midshaft fractures with upper limb function. BMC Musculoskelet Disord. 2015 Jun 17;16:151. doi: 10.1186/s12891-015-0585-3. — View Citation

Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. — View Citation

Jones GL, Bishop JY, Lewis B, Pedroza AD; MOON Shoulder Group. Intraobserver and interobserver agreement in the classification and treatment of midshaft clavicle fractures. Am J Sports Med. 2014 May;42(5):1176-81. doi: 10.1177/0363546514523926. Epub 2014 Feb 26. — View Citation

Kaplan S, Alpayci M, Karaman E, Çetin O, Özkan Y, Ilter S, Sah V, Sahin HG. Short-Term Effects of Kinesio Taping in Women with Pregnancy-Related Low Back Pain: A Randomized Controlled Clinical Trial. Med Sci Monit. 2016 Apr 18;22:1297-301. — View Citation

Kase K, Wallis J, Kase T. Clinical Therapeutic Applications of the Kinesio Taping® Method. Dallas, TX: Kinesio Taping Association; 2003.

Naveen BM, Joshi GR, Harikrishnan B. Management of mid-shaft clavicular fractures: comparison between non-operative treatment and plate fixation in 60 patients. Strategies Trauma Limb Reconstr. 2017 Apr;12(1):11-18. doi: 10.1007/s11751-016-0272-4. Epub 2017 Jan 4. — View Citation

Postacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):452-6. — View Citation

Qin M, Zhao S, Guo W, Tang L, Li H, Wang X, Zhu Z, Sun T. Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture: A meta-analysis of randomized clinical trials. Medicine (Baltimore). 2019 May;98(20):e15638. doi: 10.1097/MD.0000000000015638. — View Citation

Sang QH, Gou ZG, Zheng HY, Yuan JT, Zhao JW, He HY, Liu C, Liu Z. The Treatment of Mid-shaft Clavicle Fractures. Chin Med J (Engl). 2015 Nov 5;128(21):2946-51. doi: 10.4103/0366-6999.168068. Review. — View Citation

Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function plateaus by one year in patients with surgically treated displaced midshaft clavicle fractures. Clin Orthop Relat Res. 2011 Dec;469(12):3351-5. doi: 10.1007/s11999-011-1915-x. — View Citation

Stanley D, Trowbridge EA, Norris SH. The mechanism of clavicular fracture. A clinical and biomechanical analysis. J Bone Joint Surg Br. 1988 May;70(3):461-4. — View Citation

Tamaoki MJS, Matsunaga FT, Costa ARFD, Netto NA, Matsumoto MH, Belloti JC. Treatment of Displaced Midshaft Clavicle Fractures: Figure-of-Eight Harness Versus Anterior Plate Osteosynthesis: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Jul 19;99(14):1159-1165. doi: 10.2106/JBJS.16.01184. — View Citation

Thormodsgard TM, Stone K, Ciraulo DL, Camuso MR, Desjardins S. An assessment of patient satisfaction with nonoperative management of clavicular fractures using the disabilities of the arm, shoulder and hand outcome measure. J Trauma. 2011 Nov;71(5):1126-9. doi: 10.1097/TA.0b013e3182396541. — View Citation

Waldmann S, Benninger E, Meier C. Nonoperative Treatment of Midshaft Clavicle Fractures in Adults. Open Orthop J. 2018 Jan 17;12:1-6. doi: 10.2174/1874325001812010001. eCollection 2018. Review. — View Citation

Wiesel B, Nagda S, Mehta S, Churchill R. Management of Midshaft Clavicle Fractures in Adults. J Am Acad Orthop Surg. 2018 Nov 15;26(22):e468-e476. doi: 10.5435/JAAOS-D-17-00442. Review. — View Citation

Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000. Review. — View Citation

Woltz S, Krijnen P, Schipper IB. Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Meta-Analysis of Randomized Controlled Trials. J Bone Joint Surg Am. 2017 Jun 21;99(12):1051-1057. doi: 10.2106/JBJS.16.01068. Review. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the two groups in terms of early return to work The investigators aim is to examine the effect of kinesiotaping treatment on clavicle fracture union. 6. months
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