Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-17
Brief Title:
Kinesiotaping in Trauma
Sponsor:
Onze Lieve Vrouwe Gasthuis
Organization:
Onze Lieve Vrouwe Gasthuis
Study Overview
Official Title:
Kinesiotaping in Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIT
Brief Summary:
Rationale Patients with acute traumatic injury to the shoulder or chest wall in de Emergency Department ED usually have intense pain The patient normally is treated with oral analgesics as standard care and in shoulder injury with a sling Pain of the shoulder or chest wall increases with movement of the affected arm and chest Kinesiotaping is offered regularly as an additional pain treatment but there is no hard evidence about its effectiveness A randomized pilot study in OLVG Bakker 2022 showed the pain decreasing more when using kinesiotaping comparing to no tape However a placebo-effect could not be ruled out and the pilot data need confirmation in a large cohort of patients to study the effectiveness of additional treatment with kinesiotaping in terms of pain comfort and patient satisfaction
Detailed Description:
Objective The primary aim of this study is to evaluate the effect of kinesiotaping on number of patients with clinically meaningful pain reduction after 1 week in patients with acute traumatic injury in shoulder or chest wall compared to sham tape and no tape The secondary aims are to assess the effect of kinesiotaping on pain reduction at 15 min 3 weeks and 8 weeks and the effects on the skin use of oral analgesics independence activity pattern progress of pain symptoms comfort and patient satisfaction at 1 3 and 8 weeks Also the need of physiotherapy is one of the secondary aims
Study design Parallel randomized controlled trial with three arms
Study population Patients of or over 18 years old with an acute single shoulder or chest wall injury rib fracture disruption of the acromioclavicular AC joint Tossy type 1 and 2 not or hardly dislocated fracture of clavicle or proximal humeral bone
Intervention if applicable One group will receive treatment with kinesiotaping another group receives sham taping no elastic tape and the third group receives no taping This treatment is additional to the general treatment with oral analgesics and a sling when shoulder injury
Main study parametersendpoints The main study parameter is the proportion of patients who experienced a clinically meaningful reduction in pain score 2 points on NRS at week 1 compared to T1 The kinesiotape group will be compared to the sham group and to the control group
Nature and extent of the burden and risks associated with participation benefit and group relatedness
At 15 minutes after receiving kinesio tape sham tape or no tape 1 week 3 weeks and 8 weeks after visiting the emergency department the pain of these patients is evaluated using NRS by the Brief Pain Inventory BPI The effect of use of oral analgesics questionnaire on the skin questionnaire on independence activity pattern and progress of pain symptoms Groningen Activity Restriction Scale GARS comfort and patient satisfaction Global Perceived Effect GPE-DV is evaluated after 1 3 and 8 weeks Physiotherapy is elevated after 8 weeks Due to the limited seriousness of the injury and the non-invasive nature of the interventions any serious complication or adverse event is not expected Benefits of participating this study could be pain reduction in the affected body part
Study design Parallel randomized controlled trial with three arms
Study population Patients of or over 18 years old with an acute single shoulder or chest wall injury rib fracture disruption of the acromioclavicular AC joint Tossy type 1 and 2 not or hardly dislocated fracture of clavicle or proximal humeral bone
Intervention if applicable One group will receive treatment with kinesiotaping another group receives sham taping no elastic tape and the third group receives no taping This treatment is additional to the general treatment with oral analgesics and a sling when shoulder injury
Main study parametersendpoints The main study parameter is the proportion of patients who experienced a clinically meaningful reduction in pain score 2 points on NRS at week 1 compared to T1 The kinesiotape group will be compared to the sham group and to the control group
Nature and extent of the burden and risks associated with participation benefit and group relatedness
At 15 minutes after receiving kinesio tape sham tape or no tape 1 week 3 weeks and 8 weeks after visiting the emergency department the pain of these patients is evaluated using NRS by the Brief Pain Inventory BPI The effect of use of oral analgesics questionnaire on the skin questionnaire on independence activity pattern and progress of pain symptoms Groningen Activity Restriction Scale GARS comfort and patient satisfaction Global Perceived Effect GPE-DV is evaluated after 1 3 and 8 weeks Physiotherapy is elevated after 8 weeks Due to the limited seriousness of the injury and the non-invasive nature of the interventions any serious complication or adverse event is not expected Benefits of participating this study could be pain reduction in the affected body part
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None