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Effect of the Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule 64
Clinical Trial NCT06509516 is an interventional study for Shoulder Pain, Shoulder Pain Chronic and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2024 and continue until the study accrues 64 participants. Led by University of Alcala, this study is expected to complete by 1 November 2025. The latest data from ClinicalTrials.gov was last updated on 30 July 2024.
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 elastograph...Show More
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 ...Show More
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
Conditions
Shoulder PainShoulder Pain ChronicPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2024/3/066
NCT ID Number
Start Date (Actual)
2024-09
Last Update Posted
2024-07-30
Completion Date (Estimated)
2025-11
Enrollment (Estimated)
64
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Modified Sleeper-Stretch
Shear Wave Elastography
Posterior Capsule
GIRD
Shear Wave Elastography
Posterior Capsule
GIRD
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalShoulder pain history Execution of the Modified Sleeper-Stretch three times, for thirty seconds each time, with thirty seconds between stretches, daily, for twenty-eight days. The stretch will be applied on the shoulder with history of shoulder pain. | Modified Sleeper-Stretch Self-administered stretch in which the individual remains side-lying on the upper limb to be stretched, keeping the scapula stabilized by his/her own weight, and rolls the trunk 20-30º posteriorly, maintaining a 90º flexion in the shoulder and elbow. Using the opposite hand over the forearm of the limb to be stretched, the individual passively brings the shoulder to maximum internal rotation. |
ExperimentalNo history of shoulder pain Execution of the Modified Sleeper-Stretch three times, for thirty seconds each time, with thirty seconds between stretches, daily, for twenty-eight days. The stretch will be applied on a shoulder randomly assigned. | Modified Sleeper-Stretch Self-administered stretch in which the individual remains side-lying on the upper limb to be stretched, keeping the scapula stabilized by his/her own weight, and rolls the trunk 20-30º posteriorly, maintaining a 90º flexion in the shoulder and elbow. Using the opposite hand over the forearm of the limb to be stretched, the individual passively brings the shoulder to maximum internal rotation. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Posterior glenohumeral capsule elasticity | Elasticity of posterior glenohumeral capsule as determined by quantitative shear-wave elastography | Day 1 (twice), day 28 (twice), day 56 (once) |
Posteroinferior glenohumeral capsule elasticity | Elasticity of posteroinferior glenohumeral capsule as determined by quantitative shear-wave elastography | Day 1 (twice), day 28 (twice), day 56 (once) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Male or female with clinical history of nonspecific shoulder pain on a single shoulder, who had GIRD of 15º or more, asymptomatic for more than one month and less than one year.
- Male or female with no history of shoulder pain.
- Age between 18 and 59 years.
- Glenohumeral osteoarthritis.
- Labrum lesion, Bankart or Hill-Sachs lesion.
- Posterior instability of any of the shoulders.
- Evidence of joint hypermobility as defined by a Beighton Scale score greater or equal to 6.
- Rotator cuff tear.
- Fracture or surgery in the cervical region or in any of the upper limbs, except shoulders, if less than a year has passed since the episode.
- History of surgical intervention in any of the shoulders.
- Tumor growth in the shoulder region.
- Neuromuscular injuries with shoulder muscles motor involvement (myasthenia, spinal cord injury, spastic contracture, paresis).
- Inflammatory diseases (rheumatoid arthritis, psoriatic arthritis) affecting the shoulder region in state of outbreak.
- Metabolic or systemic diseases with potential to modify tissue elastic capacity.
- Diseases or injuries with contraindication to mobilization or physical exercise of the shoulder region.
- Inability to perform the stretch due to pain.
University of AlcalaStudy Responsible Party
Esteban Ramírez Llano, Principal Investigator, Physical Therapist, University of Alcala
Study Central Contact
Contact: Esteban Ramirez-Llano, PT, +34 635221898, [email protected]
1 Study Locations in 1 Countries
Madrid
Departamento de Enfermería y Fisioterapia, Alcalá de Henares, Madrid, 28805, Spain
Esteban Ramirez-Llano, PT, Contact, +34 635221898, [email protected]