Effect of the Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule

July 28, 2024 updated by: Esteban Ramírez Llano, University of Alcala

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Departamento de Enfermería y Fisioterapia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shoulder 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.
Other: 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.
Experimental: No 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posterior glenohumeral capsule elasticity
Time Frame: Day 1 (twice), day 28 (twice), day 56 (once)
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
Time Frame: Day 1 (twice), day 28 (twice), day 56 (once)
Elasticity of posteroinferior glenohumeral capsule as determined by quantitative shear-wave elastography
Day 1 (twice), day 28 (twice), day 56 (once)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Esteban Ramirez-Llano, PT, Member of the department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 13, 2024

First Submitted That Met QC Criteria

July 13, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/3/066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All the information obtained in the study will be only published on a statistical basis. Only the principial investigator of the study will be able to associate information of the study with any individual participant.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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