|- candidate number||3569|
|- NTR Number||NTR1374|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jul-2008|
|- Secondary IDs||NL23237.100.08 |
|- Public Title||Conservative treatment of midclavicular fractures with Kinesio® clavicular tape and sling vs sling
|- Scientific Title||Conservative treatment of midclavicular fractures with Kinesio® clavicular tape and sling vs sling
|- hypothesis||The hypothesis is that patients who recieve treatment with kinesio tape and sling will experience less pain and better shoulder function compared to patients treated with only a sling. |
|- Healt Condition(s) or Problem(s) studied||Quality of life, Fracture , Randomized Controlled Trial (RCT), Sling, Kinesio tape, Clavicula|
|- Inclusion criteria||1. Patients with a midclavicular fracture |
2. In the age from 12 to 60 years
3. With a informed consent
|- Exclusion criteria||1. Age less than twelve or greater than sixty years |
2. A pathological fracture
3. An open fracture
4. A fracture older than 28 days after injury
5. A fracture in the proximal or distal third of the clavicula
6. An associated neurovascular injury with objective neurological findings on physical examination
7. An inability to comply with the follow-up
8. A lack of consent
9. Good understanding of dutch language by word and in writing
10. The use of psychopharmacological drugs
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2008|
|- planned closingdate||1-okt-2010|
|- Target number of participants||128|
|- Interventions||The experimental group gets the Kinesio® clavicle tape application during 3 weeks in combination with sling treatment. The other group gets the sling treatment in combination with a placebo tape application.|
|- Primary outcome||Quality of life measured by the DASH (Disabilities of the Arm, Shoulder and Hand ) questionnaire|
|- Secondary outcome||- VAS (visual analoque scale)|
- Non-union percentage
- Constant score
|- Timepoints||The study will take 2 years to finish. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| B.E. Roberti|
|- CONTACT for SCIENTIFIC QUERIES|| B.E. Roberti|
|- Sponsor/Initiator ||Onze Lieve Vrouwe Gasthuis (OLVG)|
(Source(s) of Monetary or Material Support)
|Onze Lieve Vrouwe Gasthuis (OLVG)|
|- Publications||- Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007b; (89): 1-10.
Andersen K, Jensen P O, Lauritzen J. |
- Treatment of clavicular fractures. Figure-of-eight bandage versus a simple sling. Acta Orthop Scand 1987; (58): 71-74.
Jeray K J.
- Acute midshaft clavicular fracture. J Am Acad Orthop Surg 2007; (15): 239-248.
McKee M D, Pedersen E M, Jones C, Stephen D J, Kreder H J, Schemitsch E H, Wild L M, Potter J.
- Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am 2006; (88): 35-40.
Zlowodzki M, Zelle B A, Cole P A, Jeray K, McKee M D.
- Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma 2005; (19): 504-507.
|- Brief summary||Fractures of clavicula are frequently diagnosed. Of all fractures about 4 % are fractures of the clavicula. Of these about 75% are mid-shaft (3% of all fractures). Conservative sling treatment of the mid-shaft fractures dominates the therapeutic approach. Complications encountered with this procedure are mal-union, non-union, pain, restrictions of arm movements and cosmetic. The treatment has an acceptable prognosis with relative little additional morbidity. When focussing on quality of life after sling treatment there are still many complaints of pain, weakness of muscular strength and rapid fatigue of the arm muscles on exertion during the first weeks. A new type of elastic tape, Kinesio® clavicle tape in combination with sling treatment gave remarkable better results in a small pilot set-up. Relief of pain and better shoulder function was immediately experienced by all patients. These effects lasted the first weeks. |
Tape treatment has never been compared to sling treatment in a RCT.
|- Main changes (audit trail)|
|- RECORD||11-jul-2008 - 25-jul-2008|