- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04622137
Kinesiotaping Therapy for Clavicular Fractures FRACTURES:
An Alternative Conservative Treatment Method For Midshaft Clavicular Fractures: Kinesiotaping Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34040
- SBU Prof. Cemil Tascioglu City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants with midclavicle fracture within 24 hours
Exclusion Criteria:
Participants with open fractures,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Arm sling only group (group S)
Participants used only arm sling for clavicula fracture
|
|
|
Active Comparator: Arm sling with kinesiotaping therapy group (group K).
Participants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture
|
The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the two groups in terms of early return to work
Time Frame: 6. months
|
The investigators aim is to examine the effect of kinesiotaping treatment on clavicle fracture union.
|
6. months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1302/0301-620x.79b4.7529.
- Kaplan S, Alpayci M, Karaman E, Cetin O, Ozkan 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. doi: 10.12659/msm.898353.
- Akca 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.
- 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. doi: 10.1054/math.2002.0485.
- 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.
- 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. doi: 10.1302/0301-620X.70B3.3372571.
- 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.
- 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.
- 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.
- 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.
- Postacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):452-6. doi: 10.1067/mse.2002.126613.
- 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.
- Kase K, Wallis J, Kase T. Clinical Therapeutic Applications of the Kinesio Taping® Method. Dallas, TX: Kinesio Taping Association; 2003.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kinesiotaping Therapy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clavicle Fracture
-
Medipol UniversityWithdrawnClavicle Fracture | Clavicle InjuryTurkey
-
Al-Azhar UniversityRecruitingClavicle Fracture | Clavicle InjuryEgypt
-
Zimmer BiometActive, not recruiting
-
Medipol UniversityWithdrawn
-
McGill University Health Centre/Research Institute...CompletedMalunion of Fracture of Clavicle | Delayed Union of Fracture of ClavicleCanada
-
University Hospital, BrestActive, not recruitingClavicle Fracture | Pseudarthrosis | Clavicle Fracture, Non Union/MalunionFrance
-
Naval Medical Center Camp LejeuneEnrolling by invitationClavicle Fracture | Acromioclavicular Joint | Clavicle Surgery | Coracoclavicular LigamentUnited States
-
Medipol UniversityCompletedClavicle Fracture | Clavicle InjuryTurkey
-
Prince of Songkla UniversityRecruiting
-
Bichat HospitalNot yet recruiting
Clinical Trials on Kinesiotaping therapy
-
Riphah International UniversityCompletedSacral DisorderPakistan
-
Sultan Abdulhamid Han Training and Research Hospital...Completed
-
Foundation University IslamabadRecruiting
-
Dokuz Eylul UniversityUnknown
-
Cairo UniversityRecruitingMyofascial Pain SyndromeEgypt
-
Cairo UniversityCompleted
-
Foundation University IslamabadActive, not recruiting
-
Riphah International UniversityCompleted
-
Cairo UniversityCompleted
-
Yuzuncu Yıl UniversityCompletedTrapezius Muscle StrainTurkey