NCT04622137

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

October 15, 2020

Last Update Submit

November 4, 2020

Conditions

Clavicle Fracture

Keywords

kinesiotherapyarm sling

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arm sling only group (group S)

NO INTERVENTION

Participants used only arm sling for clavicula fracture

Arm sling with kinesiotaping therapy group (group K).

ACTIVE COMPARATOR

Participants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture

Procedure: Kinesiotaping therapy

Interventions

Kinesiotaping therapyPROCEDURE

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

Arm sling with kinesiotaping therapy group (group K).

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with midclavicle fracture within 24 hours

You may not qualify if:

  • Participants with open fractures,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, 34040, Turkey (Türkiye)

Location

Related Publications (23)

  • 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.

    PMID: 31096481BACKGROUND

  • 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.

    PMID: 26521795BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 28719554BACKGROUND

  • 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.

    PMID: 24573571BACKGROUND

  • 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.

    PMID: 30180095BACKGROUND

  • 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.

    PMID: 26530661BACKGROUND

  • 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.

    PMID: 9250733BACKGROUND

  • 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.

    PMID: 27088271BACKGROUND

  • 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.

    PMID: 22124445BACKGROUND

  • 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.

    PMID: 31937442BACKGROUND

  • 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.

    PMID: 12586560BACKGROUND

  • 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.

    PMID: 21590485BACKGROUND

  • 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.

    PMID: 3372571BACKGROUND

  • 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.

    PMID: 28054249BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 28632595BACKGROUND

  • 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.

    PMID: 27220117BACKGROUND

  • 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.

    PMID: 12378163BACKGROUND

  • 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.

    PMID: 22071918BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 29430265BACKGROUND

  • 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.

    PMID: 26080806BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedics and Traumatology specialist,Chief assistant

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 9, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

TU(1)