Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229964
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-09
Brief Title:
Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
A Double Blinded Randomized Controlled Trial RCT Exploring the Additional Effect of a Suprascapular Nerve Block in Combination With an Intra-Articular Corticosteroid Injection in Patients With Frozen Shoulder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
FROSTBLOCK
Brief Summary:
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years This loss of function can have a severe impact on the patients activities participation and overall quality of life
The use of ultrasound-guided USG suprascapular nerve blocks SSNB andor intra-articular corticoid injections IACI has been supported by many studies However double blinded randomized clinical trials using a combination of SSNB and IACI are rare
The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB compared to a glenohumeral IACI combined with a sham SSNB Outcome measures of interest are shoulder-related disability reported by the patients shoulder pain and shoulder stiffness These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis
As key secondary objectives the investigators aim to identify which physical examination tests or combinations of those are correlated with MRI diagnostic criteria and favor a more positive evolution Finally through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB IACI
The use of ultrasound-guided USG suprascapular nerve blocks SSNB andor intra-articular corticoid injections IACI has been supported by many studies However double blinded randomized clinical trials using a combination of SSNB and IACI are rare
The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB compared to a glenohumeral IACI combined with a sham SSNB Outcome measures of interest are shoulder-related disability reported by the patients shoulder pain and shoulder stiffness These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis
As key secondary objectives the investigators aim to identify which physical examination tests or combinations of those are correlated with MRI diagnostic criteria and favor a more positive evolution Finally through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB IACI
Detailed Description:
Frozen Shoulder FS is common disease affecting 2 to 5 of the general population with a higher prevalence in patients suffering from diabetes and thyroid dysfunctionIt remains frustrating for patients and treating health care professionals as severe shoulder pain and loss of function can last for up to two years 5-7 In the early stage most patients identify the following symptoms strong component of night pain pain with rapid or unguarded movements and aggravated by movement or lying on the affected shoulder8 Combined with marked pain and limitation in all directions of shoulder range of motion it is easy to understand that suffering from Frozen Shoulder will have a detrimental effect on quality of life and the ability to perform activities of daily living
The overall treatment aim for this condition is to improve pain and function and treatment goals should be set individually in a shared decision-making process Patient education on the clinical course and different possible therapeutic interventions including self-management strategies should always come first Clinicians should promote activity modification to utilize pain-free functional ROM and stretching of the shoulder capsule matching the patients current level of irritability
Intra-articular corticosteroid injections IACI into the gleno-humeral GH joint combined with shoulder mobility and stretching exercises have shown to be more effective in providing short-term 4-6weeks pain relief and improved function compared to exercises alone
A recent article by Rex et al places the results of the UK FROST trial in the context of 8 other randomized controlled trials comparing intra-articular corticoid injections IACI to manipulation under anesthesia MUA arthroscopic capsular release ACR and hydrodilatation These findings did not show clinical superiority of either IACI MUA nor ACR and evidence for hydrodilatation was inconclusive
Common sense in accordance with the National Institute of Health and Care Excellence NICE guidelines recommends that treatments should be offered in a stepped approach from least to most invasive In their systematic review from 2020 Challoumas et al show that in the early phase of Frozen Shoulder IA corticosteroid is associated with better short-term outcomes with possible benefits extending in the mid-terms These authors recommend to associate IACI to education for home-based exercises and physiotherapy to increase the chances of resolution of symptoms by 6 months
Unfortunately not all patients show sufficient improvement in pain and function with IACI and need other therapies The suprascapular nerve SSN provides 60 tot 70 of sensory innervation of the shoulder and suprascapular nerve block SSNB has shown in meta-analysis to significantly improve pain and ROM in patients with Frozen Shoulder This systematic review however has several limitations Blinding was not always sufficient to rule out a placebo effect different injections techniques and products local anesthetics with or without corticosteroids were used and only data for pain and ROM shoulder could be aggregated as shoulder function was not evaluated in enough trials
In a rigorous triple blinded RCT we demonstrated that three successive SSNB with local anesthetics did not improve shoulder pain and function more than three sham injections in patients suffering from subacute Frozen Shoulder On the other hand it has been hypothesized that the SSN may be involved in the pathogenesis of Frozen Shoulder and that therefore using optimal approach and drugs combination of local anesthetics and corticosteroids in SSNB should be further evaluated in high-quality RCTs
In a retrospective review of 102 patients Jung et al showed that the combination of an IACI with an SSNB further increased treatment efficacy compared to a single IACI in Frozen Shoulder patients as pain ROM and function scored significantly better at different time points 2weeks 2months and 1 year
To our knowledge there has been no previous prospective RCT investigating the added value of an SSNB in combination with an IACI delivering under ultra-sound guidance the same total amount of corticosteroids in both treatment arms and assuring quadruple blinding participant care provider investigator and outcomes assessor
The aim of this study is to determine if there is any difference in pain relief and function as measured by the Shoulder Pain and Disability Index SPADI in patients with Frozen Shoulder when given an GH IACI with a SSNB compared to an GH IACI with a sham SSNB Furthermore we want to identify which patients will benefit most from GH IACI or the combination of GH IACI and SSNB The results of this trial will help to guide clinical practice treating patients with FS and improve resource allocation
The overall treatment aim for this condition is to improve pain and function and treatment goals should be set individually in a shared decision-making process Patient education on the clinical course and different possible therapeutic interventions including self-management strategies should always come first Clinicians should promote activity modification to utilize pain-free functional ROM and stretching of the shoulder capsule matching the patients current level of irritability
Intra-articular corticosteroid injections IACI into the gleno-humeral GH joint combined with shoulder mobility and stretching exercises have shown to be more effective in providing short-term 4-6weeks pain relief and improved function compared to exercises alone
A recent article by Rex et al places the results of the UK FROST trial in the context of 8 other randomized controlled trials comparing intra-articular corticoid injections IACI to manipulation under anesthesia MUA arthroscopic capsular release ACR and hydrodilatation These findings did not show clinical superiority of either IACI MUA nor ACR and evidence for hydrodilatation was inconclusive
Common sense in accordance with the National Institute of Health and Care Excellence NICE guidelines recommends that treatments should be offered in a stepped approach from least to most invasive In their systematic review from 2020 Challoumas et al show that in the early phase of Frozen Shoulder IA corticosteroid is associated with better short-term outcomes with possible benefits extending in the mid-terms These authors recommend to associate IACI to education for home-based exercises and physiotherapy to increase the chances of resolution of symptoms by 6 months
Unfortunately not all patients show sufficient improvement in pain and function with IACI and need other therapies The suprascapular nerve SSN provides 60 tot 70 of sensory innervation of the shoulder and suprascapular nerve block SSNB has shown in meta-analysis to significantly improve pain and ROM in patients with Frozen Shoulder This systematic review however has several limitations Blinding was not always sufficient to rule out a placebo effect different injections techniques and products local anesthetics with or without corticosteroids were used and only data for pain and ROM shoulder could be aggregated as shoulder function was not evaluated in enough trials
In a rigorous triple blinded RCT we demonstrated that three successive SSNB with local anesthetics did not improve shoulder pain and function more than three sham injections in patients suffering from subacute Frozen Shoulder On the other hand it has been hypothesized that the SSN may be involved in the pathogenesis of Frozen Shoulder and that therefore using optimal approach and drugs combination of local anesthetics and corticosteroids in SSNB should be further evaluated in high-quality RCTs
In a retrospective review of 102 patients Jung et al showed that the combination of an IACI with an SSNB further increased treatment efficacy compared to a single IACI in Frozen Shoulder patients as pain ROM and function scored significantly better at different time points 2weeks 2months and 1 year
To our knowledge there has been no previous prospective RCT investigating the added value of an SSNB in combination with an IACI delivering under ultra-sound guidance the same total amount of corticosteroids in both treatment arms and assuring quadruple blinding participant care provider investigator and outcomes assessor
The aim of this study is to determine if there is any difference in pain relief and function as measured by the Shoulder Pain and Disability Index SPADI in patients with Frozen Shoulder when given an GH IACI with a SSNB compared to an GH IACI with a sham SSNB Furthermore we want to identify which patients will benefit most from GH IACI or the combination of GH IACI and SSNB The results of this trial will help to guide clinical practice treating patients with FS and improve resource allocation
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?:
False
Is an FDA AA801 Violation?:
None