Clinical trial NCT06509516: Effect of the Modified Sleeper-Stretch on the Elasticity of the Posterior and Posteroinferior Glenohumeral Capsule
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Pain
Shoulder Pain Chronic
Keywords: Modified Sleeper-Stretch
Shear Wave Elastography
Posterior Capsule
GIRD
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The same intervention, a programme of the Modified Sleeper-Stretch, will be applied on two different groups
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Posterior glenohumeral capsule elasticity
timeFrame: Day 1 (twice), day 28 (twice), day 56 (once)
measure: Posteroinferior glenohumeral capsule elasticity
timeFrame: Day 1 (twice), day 28 (twice), day 56 (once)
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Departamento de Enfermería y Fisioterapia
state: Madrid
Study officials:
affiliation: Member of the department
name: Esteban Ramirez-Llano, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.