Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517680
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Tight Control for Rotator Cuff Tendinopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Tight Treatment in Rotator Cuff Tendinopathy Rotator Cuff Tendinopathy a Randomized Controlled Trial Versus Standard Standard Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREAT
Brief Summary:
The main objective of the study is to determine whether tight management of patients in early rotator cuff tendinopathy would lead to better clinical improvement than standard management In a randomized study we propose to compare two types of management with a tight control group having one consultation per month for the first 3 months in order to readapt or intensify management whereas the control group will only be seen at 3 months after inclusion We hypothesize that this close follow-up will lead to more rapid clinical improvement and reduce the transition to chronicity and the associated costs inclusion of a medico-economic analysis taking into account in particular healthcare consumption and time off work
Detailed Description:
Shoulder pain is a frequent reason for consultation with a lifetime prevalence of 67 Every year around 1 of adults over 45 consult primary care because of shoulder pain Of these rotator cuff disorders account for around 70 Pain associated with limited function has an impact on activities of daily living and on professional activities since the peak prevalence is between the ages of 45 and 64 They also represent a very costly problem given the repeated absences from work they entail Musculoskeletal disorders recognized as occupational illnesses are on the rise with over 42000 cases reported in France in 2012 32 of them involving the shoulder In 2006 the disease was estimated to have caused the loss of 7 million working days A Swedish study also showed that the cost associated with painful shoulders was mainly represented by sick leave 84
Management of rotator cuff disorders initially involves symptomatic drug therapy painkillers and non-steroidal anti-inflammatories combined with rest and rehabilitation Then in case of insufficient improvement subacromial steroid injection is often proposed Despite the frequency of the condition there are no established recommendations for the management of these patients However a recent study showed that the combination of posture advice and subacromial steroid injection was a more cost-effective strategy than either physiotherapy alone or infiltration alone When we look at patients outcome chronic pain and impaired function are frequently seen since 30-50 of patients still have symptoms after 1-2 years It is therefore important to optimize the medical management of these patients especially as at the stage of tendinopathy without rupture because surgical management is not always able to provide clinically significant benefits in terms of pain function or quality of life
In some chronic diseases such as rheumatoid arthritis it has been shown that early and tight control leads to better clinical results as treatments are regularly and closely adapted to predefined objectives remission or low disease activity A significant improvement was also observed in diabetic patients under tight control leading to reduction in the risk of progression of retinal and neurological complications and significantly decreased risk of cardiovascular events
The GREAT protocol is a prospective randomized multicenter study comparing two groups of patients
In the experimental or tight control group patients will be seen every month for the first 3 months of follow-up During these consultations shoulder pain and function will be assessed Treatment adjustments will be proposed in line with predefined objectives
In the control group patients will have the usual follow-up for this indication ie a follow-up consultation 3 months after the 1st consultation with the rheumatologist to assess their clinical course
Management of rotator cuff disorders initially involves symptomatic drug therapy painkillers and non-steroidal anti-inflammatories combined with rest and rehabilitation Then in case of insufficient improvement subacromial steroid injection is often proposed Despite the frequency of the condition there are no established recommendations for the management of these patients However a recent study showed that the combination of posture advice and subacromial steroid injection was a more cost-effective strategy than either physiotherapy alone or infiltration alone When we look at patients outcome chronic pain and impaired function are frequently seen since 30-50 of patients still have symptoms after 1-2 years It is therefore important to optimize the medical management of these patients especially as at the stage of tendinopathy without rupture because surgical management is not always able to provide clinically significant benefits in terms of pain function or quality of life
In some chronic diseases such as rheumatoid arthritis it has been shown that early and tight control leads to better clinical results as treatments are regularly and closely adapted to predefined objectives remission or low disease activity A significant improvement was also observed in diabetic patients under tight control leading to reduction in the risk of progression of retinal and neurological complications and significantly decreased risk of cardiovascular events
The GREAT protocol is a prospective randomized multicenter study comparing two groups of patients
In the experimental or tight control group patients will be seen every month for the first 3 months of follow-up During these consultations shoulder pain and function will be assessed Treatment adjustments will be proposed in line with predefined objectives
In the control group patients will have the usual follow-up for this indication ie a follow-up consultation 3 months after the 1st consultation with the rheumatologist to assess their clinical course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None