Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509516
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Effect of the Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quasi-experimental Study Protocol to Measure the Effect of Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule by Means of Shear Wave Elastography in Adult Population
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:
None
Brief Summary:
The goal of this quasi-experimental study is to determine the effect of the self-administered Modified Sleeper-Stretch on the elasticity of the posterior and posteroinferior glenohumeral capsule in adult individuals of both genders who either have clinical history of non-specific shoulder pain in a single shoulder or have no history of shoulder pain at all being the assessment made by means of shear wave elastography The main hypothesis it aims to confirm is
A soft tissue stretching program using the Modified Sleeper-Stretch aimed at general adult population with history of nonspecific shoulder pain that has occurred with glenohumeral internal rotation deficit improves the elasticity of the posterior and posteroinferior glenohumeral capsules showing no significant effect on general adult population without history of shoulder pain
Researchers will compare the effect of the Modified Sleeper-Stretch in the elasticity of the posterior and posteroinferior glenohumeral capsule in individuals with history of shoulder pain applying the technique on the affected shoulder and comparing with the healthy shoulder In healthy individuals the intervention will be made on a randomly assigned shoulder and the effect will be compared to the non-interventional shoulder Finally a comparison between groups will be made considering only the intervention shoulder to see if there are differences in the effect amongst healthy and affected individuals
Participants will be asked to follow a self-administered Modified Sleeper-Stretch program consisting of the execution of the stretch three times for thirty seconds each time with thirty seconds between stretches daily for twenty-eight days
A soft tissue stretching program using the Modified Sleeper-Stretch aimed at general adult population with history of nonspecific shoulder pain that has occurred with glenohumeral internal rotation deficit improves the elasticity of the posterior and posteroinferior glenohumeral capsules showing no significant effect on general adult population without history of shoulder pain
Researchers will compare the effect of the Modified Sleeper-Stretch in the elasticity of the posterior and posteroinferior glenohumeral capsule in individuals with history of shoulder pain applying the technique on the affected shoulder and comparing with the healthy shoulder In healthy individuals the intervention will be made on a randomly assigned shoulder and the effect will be compared to the non-interventional shoulder Finally a comparison between groups will be made considering only the intervention shoulder to see if there are differences in the effect amongst healthy and affected individuals
Participants will be asked to follow a self-administered Modified Sleeper-Stretch program consisting of the execution of the stretch three times for thirty seconds each time with thirty seconds between stretches daily for twenty-eight days
Detailed Description:
Non-specific shoulder pain is the third most frequent among musculoskeletal pains It causes functional limitation that can lead to capsular stiffness and restriction of movement Interventions aimed at reducing posterior capsule stiffness may improve the symptoms of painful shoulder Modified Sleeper-Stretch is credited with the ability to decrease posterior shoulder stiffness Shear-wave elastography is an imaging technique capable of quantifying the stiffness of the posterior capsule of the shoulder
The objective of this study is to determine the effect of a stretching program using Modified Sleeper-Stretch on the elasticity of the posterior and posteroinferior capsule of the glenohumeral joint in adult population with and without a history of non-specific shoulder pain using shear-wave elastography
A quasi-experimental pre-post study will be conducted over two experimental groups of 32 subjects each The intervention will involve following a self-stretching program of the posterior region of the shoulder using modified sleeper-stretch for 28 days The study subjects will be adult individuals with a history of non-specific shoulder pain in the first group and no history of shoulder pain in the second The first group will follow the program on the affected shoulder the second on a randomly assigned shoulder The elasticity of the posterior and posteroinferior glenohumeral capsule will be measured by shear-wave elastography in both shoulders at the beginning of the intervention at its completion and four weeks after the end of the intervention
The objective of this study is to determine the effect of a stretching program using Modified Sleeper-Stretch on the elasticity of the posterior and posteroinferior capsule of the glenohumeral joint in adult population with and without a history of non-specific shoulder pain using shear-wave elastography
A quasi-experimental pre-post study will be conducted over two experimental groups of 32 subjects each The intervention will involve following a self-stretching program of the posterior region of the shoulder using modified sleeper-stretch for 28 days The study subjects will be adult individuals with a history of non-specific shoulder pain in the first group and no history of shoulder pain in the second The first group will follow the program on the affected shoulder the second on a randomly assigned shoulder The elasticity of the posterior and posteroinferior glenohumeral capsule will be measured by shear-wave elastography in both shoulders at the beginning of the intervention at its completion and four weeks after the end of the intervention
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