Clavicle Fracture Clinical Trial
Official title:
An Alternative Conservative Treatment Method For Midshaft Clavicular Fractures: Kinesiotaping Therapy
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 |
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.
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, |
Country | Name | City | State |
---|---|---|---|
Turkey | SBU Prof. Cemil Tascioglu City Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization |
Turkey,
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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03094481 -
Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture
|
N/A | |
Recruiting |
NCT04161534 -
KT Tape for Pediatric Clavicle Fractures
|
N/A | |
Completed |
NCT06050473 -
Supraclavicular Nerve During Clavicle ORIF
|
N/A | |
Not yet recruiting |
NCT05579873 -
Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
|
||
Not yet recruiting |
NCT05262998 -
Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures
|
N/A | |
Completed |
NCT02769117 -
Bone Ultrasound to Access Fracture Healing
|
N/A | |
Withdrawn |
NCT04986553 -
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
|
||
Recruiting |
NCT05810129 -
Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture
|
N/A | |
Enrolling by invitation |
NCT05327959 -
A.L.P.S. Clavicle Plating System PMCF
|
N/A | |
Recruiting |
NCT05867355 -
Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
|
||
Completed |
NCT00872105 -
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
|
N/A | |
Withdrawn |
NCT00849771 -
Operative Versus Nonoperative Treatment for Scapula Fractures
|
N/A | |
Completed |
NCT05268874 -
The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery
|
N/A | |
Recruiting |
NCT04250415 -
Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
|
||
Withdrawn |
NCT01133769 -
Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma
|
N/A | |
Completed |
NCT06269562 -
SPSIPB and CPB on Clavicle Surgeries
|
N/A | |
Completed |
NCT01405703 -
Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
|
N/A | |
Completed |
NCT01410032 -
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
|
Phase 2 | |
Suspended |
NCT05454306 -
Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
|
N/A | |
Completed |
NCT03402269 -
Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
|