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Shoulder PainNCT06509516

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

A study testing Modified Sleeper-Stretch in people with Shoulder Pain and Shoulder Pain Chronic, run by University of Alcala at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Shoulder Pain, Shoulder Pain Chronic
What is being tested?
Modified Sleeper-Stretch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSpain
Study dates
Sep 2024to Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Esteban Ramirez-Llano, PT contact

+34 635221898

esteban.ramirez@edu.uah.es

Spain1 site
  • Departamento de Enfermería y Fisioterapia

    Alcalá de Henares, Madrid, 28805

    Esteban Ramirez-Llano, PT, +34 635221898, esteban.ramirez@edu.uah.es

Other trials in Spain

About this study

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

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.
Read more

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.

Read the 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.

Being tested
Modified Sleeper-Stretch
Keywords
Modified Sleeper-Stretch, Shear Wave Elastography, Posterior Capsule, GIRD
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Sleeper-StretchOther

    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.

Study groups in NCT06509516
Study groupRoleWhat they receive
Shoulder pain historyExperimentalExecution 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.
Receives: Other: Modified Sleeper-Stretch
No history of shoulder painExperimentalExecution 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.
Receives: Other: Modified Sleeper-Stretch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Posterior glenohumeral capsule elasticity

    Elasticity of posterior glenohumeral capsule as determined by quantitative shear-wave elastography

    Measured: Day 1 (twice), day 28 (twice), day 56 (once)

  2. Posteroinferior glenohumeral capsule elasticity

    Elasticity of posteroinferior glenohumeral capsule as determined by quantitative shear-wave elastography

    Measured: Day 1 (twice), day 28 (twice), day 56 (once)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The same intervention, a programme of the Modified Sleeper-Stretch, will be applied on two different groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509516
Sponsor's protocol ID
2024/3/066
Status last verified
Jul 2024
First submitted
13 Jul 2024
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Jacome-Lopez R, Tejada-Gallego J, Silberberg JM, Garcia-Sanz F, Garcia-Muro-San Jose F. Glenohumeral internal rotation deficit in general population with shoulder pain: A descriptive observational study. Medicine (Baltimore). 2023 Dec 15;102(50):e36551. doi: 10.1097/MD.0000000000036551.

    PubMed 38115341
  • Rosa DP, Borstad JD, Ferreira JK, Gava V, Santos RV, Camargo PR. Comparison of specific and non-specific treatment approaches for individuals with posterior capsule tightness and shoulder impingement symptoms: A randomized controlled trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):648-658. doi: 10.1016/j.bjpt.2021.04.003. Epub 2021 May 4.

    PubMed 34001426
  • Borstad JD, Dashottar A. Quantifying strain on posterior shoulder tissues during 5 simulated clinical tests: a cadaver study. J Orthop Sports Phys Ther. 2011 Feb;41(2):90-9. doi: 10.2519/jospt.2011.3357. Epub 2010 Nov 10.

    PubMed 21169717
  • Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.

    PubMed 18668168
  • Wilk KE, Hooks TR, Macrina LC. The modified sleeper stretch and modified cross-body stretch to increase shoulder internal rotation range of motion in the overhead throwing athlete. J Orthop Sports Phys Ther. 2013 Dec;43(12):891-4. doi: 10.2519/jospt.2013.4990. Epub 2013 Oct 30.

    PubMed 24175603
  • Mine K, Nakayama T, Milanese S, Grimmer K. Effectiveness of Stretching on Posterior Shoulder Tightness and Glenohumeral Internal-Rotation Deficit: A Systematic Review of Randomized Controlled Trials. J Sport Rehabil. 2017 Jul;26(4):294-305. doi: 10.1123/jsr.2015-0172. Epub 2016 Aug 24.

    PubMed 27632891
  • Izumi T, Aoki M, Muraki T, Hidaka E, Miyamoto S. Stretching positions for the posterior capsule of the glenohumeral joint: strain measurement using cadaver specimens. Am J Sports Med. 2008 Oct;36(10):2014-22. doi: 10.1177/0363546508318196. Epub 2008 Jun 20.

    PubMed 18567716
  • McClure P, Balaicuis J, Heiland D, Broersma ME, Thorndike CK, Wood A. A randomized controlled comparison of stretching procedures for posterior shoulder tightness. J Orthop Sports Phys Ther. 2007 Mar;37(3):108-14. doi: 10.2519/jospt.2007.2337.

    PubMed 17416125
  • Yamauchi T, Hasegawa S, Nakamura M, Nishishita S, Yanase K, Fujita K, Umehara J, Ji X, Ibuki S, Ichihashi N. Effects of two stretching methods on shoulder range of motion and muscle stiffness in baseball players with posterior shoulder tightness: a randomized controlled trial. J Shoulder Elbow Surg. 2016 Sep;25(9):1395-403. doi: 10.1016/j.jse.2016.04.025. Epub 2016 Jul 27.

    PubMed 27475455
  • Tawfik A, Toci GR, Sirch F, Gibbs B, Conte E, Fletcher D, Hornstein J, Aland C. The Effects of Sleeper and Superman Stretches on Time-Zero Shoulder Range of Motion in Collegiate Athletes. Cureus. 2022 Feb 25;14(2):e22600. doi: 10.7759/cureus.22600. eCollection 2022 Feb.

    PubMed 35371739
  • Chepeha JC, Magee DJ, Bouliane M, Sheps D, Beaupre L. Effectiveness of a Posterior Shoulder Stretching Program on University-Level Overhead Athletes: Randomized Controlled Trial. Clin J Sport Med. 2018 Mar;28(2):146-152. doi: 10.1097/JSM.0000000000000434.

    PubMed 28731885
  • Takenaga T, Sugimoto K, Goto H, Nozaki M, Fukuyoshi M, Tsuchiya A, Murase A, Ono T, Otsuka T. Posterior Shoulder Capsules Are Thicker and Stiffer in the Throwing Shoulders of Healthy College Baseball Players: A Quantitative Assessment Using Shear-Wave Ultrasound Elastography. Am J Sports Med. 2015 Dec;43(12):2935-42. doi: 10.1177/0363546515608476. Epub 2015 Oct 15.

    PubMed 26473012
  • Iida N, Taniguchi K, Watanabe K, Miyamoto H, Taniguchi T, Fujimiya M, Katayose M. Relationship between shear modulus and passive tension of the posterior shoulder capsule using ultrasound shear wave elastography: A cadaveric study. J Biomech. 2020 Jan 23;99:109498. doi: 10.1016/j.jbiomech.2019.109498. Epub 2019 Nov 9.

    PubMed 31735360
  • Iida N, Taniguchi K, Watanabe K, Miyamoto H, Taniguchi T, Teramoto A, Katayose M. Effective stretching positions for the posterior shoulder capsule as determined by shear wave elastography. J Shoulder Elbow Surg. 2021 May;30(5):1186-1195. doi: 10.1016/j.jse.2020.08.021. Epub 2020 Sep 9.

    PubMed 32919046

Questions about this trial

What is this clinical trial studying?

A study testing Modified Sleeper-Stretch in people with Shoulder Pain and Shoulder Pain Chronic, run by University of Alcala at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esteban Ramirez-Llano, PT (+34 635221898, esteban.ramirez@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Posterior glenohumeral capsule elasticity (time frame: Day 1 (twice), day 28 (twice), day 56 (once)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06509516, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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