Clavicle FractureNCT04622137
Kinesiotaping Therapy for Clavicular Fractures FRACTURES:
A study testing Kinesiotaping therapy in people with Clavicle Fracture, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Kinesiotaping therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with midclavicle fracture within 24 hours
Who cannot join
- Participants with open fractures,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Prof. Cemil Tascioglu City Hospital
Istanbul, 34040
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Clavicle Fracture
- Being tested
- Kinesiotaping therapy
- Keywords
- kinesiotherapy, arm sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotaping therapyProcedure or surgery
The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Kinesiotaping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622137
- Sponsor's protocol ID
- Kinesiotaping Therapy
- Status last verified
- Nov 2020
- First submitted
- 15 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31096481Sang 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.
PubMed 26521795Craig 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.
PubMed 28719554Jones 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.
PubMed 24573571Wiesel 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.
PubMed 30180095Ersen 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.
PubMed 26530661Hill 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.
PubMed 9250733Kaplan 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.
PubMed 27088271Williams 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.
PubMed 22124445Akca 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.
PubMed 31937442Alexander 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.
PubMed 12586560Schemitsch 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.
PubMed 21590485Stanley 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.
PubMed 3372571Naveen 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.
PubMed 28054249
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Conservative Treatment Method For Midshaft Clavicular Fractures: Kinesiotaping Therapy
- ClinicalTrials.gov ID
- NCT04622137
- Acronym / sponsor ID
- Kinesiotaping Therapy
- Conditions
- Clavicle Fracture
- Keywords
- kinesiotherapy, arm sling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Kinesiotaping therapyParticipants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with midclavicle fracture within 24 hours
Key exclusion criteria (1 listed)
- Participants with open fractures,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotaping therapyThe investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula. | Procedure or surgery | Arm sling with kinesiotaping therapy group (group K). |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 31096481Qin 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.
- Background: PubMed 26521795Sang 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.
- BackgroundCraig 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: PubMed 28719554Tamaoki 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.
- Background: PubMed 24573571Jones 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.
- Background: PubMed 30180095Wiesel 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.
- Background: PubMed 26530661Ersen 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.
- Background: PubMed 9250733Hill 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.
- Background: PubMed 27088271Kaplan 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.
- Background: PubMed 22124445Williams 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.
- Background: PubMed 31937442Akca 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.
- Background: PubMed 12586560Alexander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping therapy in people with Clavicle Fracture, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the two groups in terms of early return to work (time frame: 6. months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04622137, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.